Medication dosing error causes death of minor — strict liability of pharmacistsError en dosis de medicamento causa muerte de menor — responsabilidad objetiva de farmacéuticas

“VI.- PRELIMINARY ANALYSIS OF CIVIL LIABILITY. Once the aforementioned aspect has been resolved, before addressing the remaining substantive grievances, it is appropriate to refer to the topic of civil liability and its evolution within the framework of so-called strict liability (responsabilidad objetiva). Throughout history and the teaching of law, the image has been promoted that the source of all important legal institutions is found in Roman Law, more specifically in what is known as Roman Law of the classical period. Civil liability does not escape this view. Thus, authors such as Diez Picazo and Ponce de León establish that the initial seed of civil liability is found in that law. Let us analyze why. According to what these authors establish, the possibility of requesting civil compensation in Rome arises within the scope of criminal action. Thus, for example, the civil action was related to the “furtum,” which was an action of a penal nature exercised on the occasion of infringements of rights or of a thing. On the other hand, another action was the “damnun innuria datum” which, thanks to the Tribune Aquilino, gave rise to the so-called “Lex Aquilia.” Among the most important rules of said law, we have the possibility of requesting compensation for the loss of slaves or some quadruped, so that, definitively, said action derives from material damage caused (Digesto 9, 2, 2). Another important element for the evolution of this type of civil action is praetorian law, given that by its nature it was a less formal law and in which equity begins to have important content, in order to determine the nature and quantification of the damage. Within the framework of these normative sources, we can conclude that in “classical” Roman Law the following actions existed: 1. Actions for the injury or destruction of things, this gave rise to the exercise of the so-called “inuiria,” which was an action exercised as long as there was a causal link with the damage. 2. Actions for bodily injury and damages caused to the person. 3. Actions for damages caused by animals or by the negligence of the person (for example, damages while riding). 4. Action for willful misconduct (dolo), that is, having acted with the intention of generating damage. 5. Finally, the “inuiria” evolves to become an action that protects personality rights, but also continues to protect infringements of the right to possession and property. Subsequently, the influence of the glossators and the natural law commentators proves decisive in the evolution of civil liability, mainly for two aspects. The first lies in the fact that the spectrum of liability is broadened to situations generated not only by the person causing the damage, but also for actions carried out by servants, which generated the liability of their master or mistress – beginnings of fault “in vigilando.” The second aspect has to do with the standing to claim compensation, because in this stage the heirs of the victim were allowed to collect compensation upon death, such as could be for maintenance. Within the evolutionary framework of liability, authors such as [Nombre1] and [Nombre2] had an important influence, who formed the Naturalist School that influenced the Code. The contribution of the former consists of deriving the civil action from an “illicit” act that could be caused by willful misconduct (dolo) or by culpable or negligent action. Along these same lines, [Nombre2] classifies the three types of causes from which the right to request compensation could derive; among these we have, quasi-contracts, contractual breaches, and crimes or delicts. The influence of these schools determined that in the year 1792, a rule was enacted in the Prussian Code establishing the following: “Any damage caused by willful misconduct (dolo) or by gross negligence that generates a serious personal illness or death must be punishable.” The Code also takes this same orientation by establishing: “Article 1382. ‘Of delicts and quasi-delicts. Any act of man, which causes damage to another, obliges the one through whose fault it occurred to repair it.’ Article 1383. One is responsible not only for the damage caused by one's own act, but also for the act of the persons for whom one must answer or of the things one has under one's guard.’” Evidently, all this codification has an influence on our national law. Suffice it to read Article 1045 of the Civil Code to perceive it, however, it is necessary to highlight how the perspective on the nature of civil liability cannot be exhausted only within this provision. The provision in question starts, like Napoleonic legislation, from an act that is not only willful but also negligent and imprudent on the part of the agent who generates the damage. Also, as a result of the historical and social moments surrounding France in the 18th century, it starts from an individualistic relationship between the agent and the victim, given that not even in the mentality of the Legislative Power of that era were the effects of the theory of risk inherent to mass industrial or commercial activity assessed. We must remember that in the year 1804, in France, what was developing was an agricultural or artisanal economy, so it was difficult to foresee the changes introduced by the Industrial Revolution. Another important aspect to explain the regulations from which ours derive is the important influence of Canon Law. Evidently, rules such as Article 1045 start from a premise from which derives the obligation of the victim to prove who the person was who generated the willful or culpable action that ultimately caused the damage. When the victim was faced with situations in which they could not prove these circumstances, whether due to lack of evidence or difficulty in obtaining it –due to the impossibility of obtaining it from the agent–, it was indicated that we were in the presence of “acts of God” of those that were executed as punishment upon the victim, therefore not compensable. In this way, the compensation for damage was viewed as the “payment of a sin” and not as an indemnification for the victim. In summary, the criteria of subjective imputation entail that the burden of proof of willful misconduct (dolo) or negligence or imprudence falls on the victim, which in our current society is very difficult, due to the socio-economic development of companies and the accelerated growth of the State. Let us analyze this well. In the last two hundred years, the world has experienced an accelerated evolution, so that social relations have become very complex. This complexity brings as a consequence a greater possibility of generating damages, previously unimaginable, product of scientific and technological development, which are produced not only by the growth of companies but also by the State and its institutions as entities that relate to persons who come before them to consume a good or a service. In the case of state services such as health, education, citizen security, banking services, etcetera, there is an eminently risky activity that is prone to the production of damages. Under this line of thought, it became necessary to provide the consumer of those goods or services with special protection against those possible damages, through a civil liability regime viewed from a new perspective that would break the general principle of subjective imputation, to adapt to the demands imposed by the transformation of social realities. And it is that these realities cause that, due to the structure in the division of the work that is executed, when damage occurs to the detriment of the user, it is very difficult for them to attribute that willful misconduct (dolo) or negligence to any specific employee or official, since in the provision of a service or in the manufacture of a good multiple agents intervene, which on many occasions can lead to a denial of justice. For this reason, faced with the impossibility of the user or consumer to demonstrate the existence of fault, most modern legal systems opt for a system of strict liability civil liability, which essentially addresses the production of the damage, regardless of whether there was fault or willful misconduct (dolo) in its commission. Therefore, the person causing the harmful event can only be exonerated if they manage to demonstrate that there is no causal link between the conduct that generates the damage and the damage itself. Likewise, there are mechanisms that guarantee the possibility of extending the liability generated by the damage not only to companies or state entities, but also to the employees or officials who participate in the provision of the service or in the elaboration of the product. As examples of these rules that establish criteria of strict liability, we have Article 190 of the General Law of Public Administration and, more recently, Article 35 of the Law for the Promotion of Competition and Effective Consumer Defense, which, as we will explain, are not mutually exclusive.

“VII.- ARTICLE 35 AND ITS APPLICATION IN THE CASE OF THE COSTA RICAN SOCIAL SECURITY FUND. Article 190 cited above constitutes a rule that, in a general manner, is used to apply a criterion of strict liability in the case of liability of the State and its institutions. The rule states: ‘The Administration shall be liable for all damages caused by its legitimate or illegitimate, normal or abnormal functioning, except for force majeure, fault of the victim, or act of a third party.’ This rule has the particularity that it only allows claiming compensation from the state administration, but not from the public servants who were involved in the commission of the damage to the detriment of the user. However, this rule is not the only one that allows extracting this type of strict liability, especially since the entry into force in our legal system of Article 35 of the Law for the Promotion of Competition and Effective Consumer Defense. The first paragraph of this article states: ‘The producer, the supplier, and the merchant must respond concurrently and independently of the existence of fault, if the consumer is harmed by reason of the good or service, inadequate or insufficient information about them or their use and risks. Only the one who demonstrates that they have been unrelated to the damage is released.’ (The emphasis and underlining is ours). On the other hand, Article 2 of the same law defines the supplier as: ‘Any physical person, legal or de facto entity, private or public, that, in its own name or on behalf of another, is habitually dedicated to offering, distributing, selling, leasing, granting the use or enjoyment of goods or to providing services, without this necessarily being its main activity…’ (The emphasis is ours). From the reading of this paragraph, it is possible to conclude that the Costa Rican Social Security Fund (Caja Costarricense de Seguro Social) is a public entity provider (proveedora) of goods and services to its users, to which the liability derived from Article 35 is applicable. However, unlike Article 190, this liability is not exhausted with the public provider entity, but extends, jointly and severally, to a certain type of specialized personnel who work in it. In this regard, paragraph 2 of Article 35 provides that ‘…The technicians, those in charge of elaboration and control respond jointly and severally, when it so corresponds, for violations of this law to the detriment of the consumer.’ In this case, this category of workers, due to their particular functions, can be imputed liability in the event of damage caused to the consumer or user, whether on the occasion of the good or service provided, or for inadequate or insufficient information regarding these or their use and risks. Specifically, in the case of the persons in charge of the control of goods and services, it refers to those whose function is to verify that all established procedures have been followed to guarantee safety and efficiency in the service ([Nombre3], . ‘Civil liability for products in Mexico, Canada and the United States’, 2001).

VIII.- THE DEFENDANTS EXERCISED CONTROL OVER THE PRESCRIPTIONS DISPENSED AT THE HOSPITAL. Once we have set forth the foregoing, it is time to make a brief outline of the essential situations of this case. It has been proven in the proceedings that, on January twenty-sixth, two thousand, the minor (a few days old) [Nombre4], was admitted to the San Rafael de Alajuela Hospital, since he suffered from generalized cyanosis crises. At that moment, due to the convulsive crisis he was presenting, he was treated with sodium valproate, remaining hospitalized until February ninth, two thousand. On that date he was discharged; however, it was recommended to continue applying said medication, so the corresponding medical prescription was issued, which was dispensed to him, along with the dosage instructions by the persons working in the hospital pharmacy, and was delivered to the plaintiff herein, as the child's mother. At that time, the plaintiff herein was barely fifteen years old. On that date, the defendants herein, [Nombre5], [Nombre6], [Nombre7], and [Nombre8], held the position of pharmacists of the hospital and had shared tenure from seven in the morning to ten at night. On the label affixed to the bottle of sodium valproate, it was erroneously indicated that the minor should consume ‘three droppers full’ per day orally and not three drops as, in reality, was correct, according to the recommended dose for a person of that age. Upon withdrawing the medication, the plaintiff returned in order to clarify the dose that the minor should ingest, but she was not attended to, so she made her son take the three droppers full of the medication. Due to this, on February eleventh of the same year, the child suffered a reaction and was taken by his grandmother to the same hospital where he was hospitalized and subsequently referred to the Children's Hospital where, finally, he died on February twentieth, as a result of poisoning with sodium valproate, which also caused him acute brain damage (hypoxic encephalopathy) and multi-organ failure. Evidently, one of the essential aspects of the process revolves around the liability of the defendants, as pharmacists, in charge of controlling the dosage instructions that the child [Nombre4] had to ingest. As we explained previously, this liability is assigned based on criteria of strict liability (with foundation in Article 35 ibidem), given that it was as a consequence of incorrect information contained on the medication bottle that led the adolescent mother to give him a fatal dose that ended her baby's life. In this sense, there is extensive documentary evidence in the file that demonstrates the control and supervision functions that, due to their position, the defendants were obliged to perform. Firstly, the Organization and Administrative Functioning Manual of Pharmacies of the Costa Rican Social Security Fund (folios 384 to 445), in its chapter XV, establishes a whole procedure for the receipt and withdrawal of medications in hospitalization services. It specifies there that it is the doctor who issues the prescription for the patient, which is subsequently sent to the pharmacy to obtain medications (folio 443). Once in the pharmacy, the prescriptions are received by an official, who notes the time and date of receipt (Article 52, folio 443), and then the prescriptions, together with the medical file, are given to the pharmacist for them to carry out an INITIAL REVIEW (Article 52, folio 443). Article 53 establishes that the technical review of the prescription must be done by a pharmacy professional, who must ensure that the therapeutic profile is included, since, otherwise, a new profile is added. Once done, it is sent to the labeling area, where the medicines are labeled by machine or by automatic means; these labels must contain the following information: hospitalization service, name of the patient, name of the medication, strength, DOSE, quantity, date, and special instructions (Article 54). From there they pass to the prescription preparation area, where once the groups of prescriptions are ready with respective labels, they are placed on the FINAL REVIEW table (Article 55). This FINAL REVIEW is performed by the pharmacist whose responsibility it is to review that the prescription is correctly prepared and that the instructions on the labels are correct; the label is affixed, then the medications along with the prescription are passed to the medication delivery area (Article 56). These rules are clear in that they establish the responsibility of the pharmacists, as technical personnel, to control the entire medication delivery procedure and the elaboration of the respective labels with the indication of the doses that the service users must take. As if that were not enough, the Hospital itself where the defendants worked had a whole technical procedure established for the pharmacy department (folios 446 to 481). Said procedure, like the manual cited above, indicated that the initial review of the medical prescription corresponded to the pharmacist, whose duty is to interpret the prescription administratively, technically, making any necessary clarification (folio 466). It also corresponds to said professional to establish the instructions required for labeling and the quantity to be dispensed and to send it to the computer system. In the event that the prescription does not meet the administrative or technical requirements, such as: personal data, legible handwriting, dosing, strength, days of treatment, route of administration, exhausted or non-official medication, drug interaction, etcetera; they must RETURN the prescription to the doctor or to medical records, via the patient or with technical pharmacy personnel if possible (folio 467). Thus, the defendants, as pharmacists who were on duty the day the medications were dispensed and delivered to the plaintiff herein, were responsible for controlling that the label attached to the bottle fulfilled establishing the adequate dose for the plaintiff's son, as this is part of the functions that correspond to them as pharmacy professionals, according to the indicated manual and the internal procedure established in the hospital. Having breached that control function, since the bottle of medicine was delivered with an incorrect dose, the defendants are strictly liable, objectively, for the death of the minor [Nombre4].” As examples of these norms that establish criteria for objective imputation (imputación objetiva), we have numeral 190 of the Ley General de la Administración Pública and, more recently, article 35 of the Ley de Promoción de la competencia y de defensa efectiva del Consumidor, which, as we will explain, are not mutually exclusive. “VII.- NUMERAL 35 AND ITS APPLICATION IN THE CASE OF THE CAJA COSTARRICENSE DEL SEGURO SOCIAL. The aforementioned article 190 constitutes a norm that, in general, is used to apply a criterion of objective imputation (imputación objetiva) in the case of civil liability (responsabilidad civil) of the State and its institutions. The norm states “The Administration shall be liable for all damages caused by its legitimate or illegitimate, normal or abnormal functioning, except in cases of force majeure (fuerza mayor), fault of the victim, or act of a third party.” This norm has the particularity that it only allows demanding compensation from the state administration, but not from the public servants involved in causing the damage to the user. However, this norm is not the only one that allows deriving this type of strict liability (responsabilidad objetiva), especially since the entry into force in our legal system of numeral 35 of the law for the promotion of competition and effective consumer defense. The first paragraph of that numeral establishes “The producer, the provider (proveedor), and the merchant must respond concurrently and independently of the existence of fault, if the consumer is harmed by reason of the good or service, by inadequate or insufficient information about them, or by their use and risks. Only he who demonstrates that he was unrelated to the damage is released. “ (The emphasis and underlining are ours). On the other hand, numeral 2 of the same law defines the provider (proveedor) as “Any natural person, public or private legal entity that, in its own name or on behalf of another, is habitually engaged in offering, distributing, selling, leasing, granting the use or enjoyment of goods, or providing services, without this necessarily being its main activity…” (The emphasis is ours). From reading this paragraph, it is possible to conclude that the Caja Costarricense de Seguro Social is a public entity provider of goods and services to its users, to which the civil liability (responsabilidad civil) derived from numeral 35 is applicable.

However, unlike Article 190, this liability is not limited to the public provider entity but extends, on a joint and several basis, to certain types of specialized personnel working within it. In this regard, paragraph 2 of Article 35 provides that "</span><span style=\"font-weight:bold; font-style:italic\">…The technicians, those in charge of preparation and control are jointly and severally liable, when applicable, for violations of this law to the detriment of the consumer"</span><span>. Under this assumption, this category of workers, due to their particular functions, may be charged with liability in the event of harm caused to the consumer or user, whether on the occasion of the good or service provided, or due to inadequate or insufficient information regarding them or their use and risks. Specifically, in the case of the persons in charge of controlling goods and services, it refers to those whose function is to verify that all established procedures have been followed to guarantee safety and efficiency in the service ([Name3], "Civil liability for products in Mexico, Canada and the United States", 2001). </span><span style=\"font-weight:bold\">VIII.- THE DEFENDANTS EXERCISED CONTROL OVER THE PRESCRIPTIONS DISPENSED AT THE HOSPITAL. </span><span>Having set forth the foregoing, it is now time to make a brief outline of the essential circumstances of this case. It has been proven in the record that, on January twenty-sixth, two thousand, the minor (a few days old) [Name4]</span><span style=\"-aw-import:spaces\">&#xa0;&#xa0; </span><span>, was admitted to the Hospital de San Rafael de Alajuela, as he was suffering from generalized cyanosis crises. At that time, due to the convulsive crisis he was presenting, he was treated with sodium valproate, remaining hospitalized until February ninth, two thousand. On that date he was discharged; however, it was recommended to continue administering said medication, so the corresponding medical prescription was issued, which was dispensed, together with the dosage instructions, by the persons working in the hospital pharmacy and delivered to the plaintiff herein, as the child's mother. At that time, the plaintiff herein was barely fifteen years old. On that date, the defendants herein, [Name5]</span><span style=\"-aw-import:spaces\">&#xa0; </span><span>, [Name6]</span><span style=\"-aw-import:spaces\">&#xa0; </span><span>, [Name7]</span><span style=\"-aw-import:spaces\">&#xa0;&#xa0; </span><span>and [Name8]</span><span style=\"-aw-import:spaces\">&#xa0; </span><span>, held the position of pharmacists at the hospital and were jointly in charge of the pharmacy from seven in the morning to ten at night. On the label affixed to the sodium valproate bottle, it was erroneously indicated that the minor should consume "three droppers" per day orally and not three drops, as was, in fact, correct according to the recommended dose for a person of that age.</span><span>&#xa0;</span><span> Upon picking up the medication, the plaintiff returned with the purpose of clarifying the dose the minor should ingest, but she was not attended to, and therefore, she made her son take the three droppers of the medication. As a result, on February eleventh of the same year, the child suffered a reaction and was taken by his grandmother to the same hospital where he was admitted and later referred to the Hospital de Niños where he finally died on February twentieth, as a result of sodium valproate poisoning, which also caused acute brain damage (hypoxic encephalopathy) and multi-organ failure. Evidently, one of the essential aspects of the proceedings revolves around the liability of the defendants, as pharmacists, in charge of controlling the dosage instructions that the child [Name4] was to ingest. As we explained previously, said liability is assigned based on strict liability criteria (based on Article 35 ibidem), given that it was as a consequence of incorrect information contained on the medication bottle that led the adolescent mother to give a fatal dose that ended her baby's life. In this sense, the case file contains extensive documentary evidence demonstrating the control and supervision functions that, due to their position, the defendants were obliged to perform. First, the Manual de Organización y Funcionamiento Administrativo de Farmacias of the Caja Costarricense del Seguro Social (pages 384 to 445), in its chapter XV, establishes an entire procedure for the receipt and dispensing of medications in hospitalization services. It specifies there that it is the physician who issues the prescription for the patient, which is subsequently sent to the pharmacy to obtain medications (page 443). At the pharmacy, the prescriptions are received by an official, who notes the time and date of receipt (Article 52, page 443) and </span><span style=\"font-weight:bold; font-style:italic\">then the prescriptions, along with the medical record, are delivered to the pharmacist to carry out an INITIAL REVIEW </span><span>(Article 52, page 443). Article 53 </span><span style=\"font-weight:bold\">establishes that the technical review of the prescription must be done by a professional pharmacist</span><span>, who must ensure that the therapeutic profile is included, since, otherwise, a new profile is added. Once done, it is sent to the labeling area, where the medicines are labeled by machine or by an automatic means; said labels must contain the following information: hospitalization service, patient's name, name of the medication, strength, </span><span style=\"font-weight:bold; font-style:italic\">DOSE, </span><span>quantity, date, and special instructions (numeral 54). From there they go to the prescription fulfillment area, where once the groups of prescriptions are ready with their respective labels, they are placed on the </span><span style=\"font-weight:bold\">FINAL REVIEW </span><span>table (Article 55). Said </span><span style=\"font-weight:bold\">FINAL REVIEW </span><span>is performed by the pharmacist, whose responsibility it is to check that </span><span style=\"font-weight:bold; text-decoration:underline\">the prescription is prepared correctly and that the label instructions are correct</span><span style=\"text-decoration:underline\">,</span><span> the label is affixed, then the medications together with the prescription are passed to the medication delivery area (Article 56). These rules are clear in that they establish the responsibility of the pharmacists, as technical personnel, to control the entire procedure for delivering medications and preparing the respective labels indicating the doses that the service users must take. As if that were not enough, the Hospital itself where the defendants worked had an entire established technical procedure for the pharmacy department (pages 446 to 481). Said procedure, like the aforementioned manual, indicated that the initial review of the medical prescription corresponded to the pharmacist, whose duty is to interpret the administrative prescription technically, making any necessary clarification (page 466). It also corresponds to said professional to establish the instructions required for labeling and the quantity to dispense and to enter them into the computer system. In the event that the prescription does not meet the administrative or technical requirements, such as: personal data, legible handwriting, dosage, strength, days of treatment, route of administration, depleted or non-formulary medication, drug interaction, etc.; the prescription must be RETURNED to the physician or to medical records, through the patient or with technical pharmacy personnel if possible (page 467). Therefore, the defendants, as pharmacists who were on duty the day they were dispensed and delivered to the plaintiff herein, were responsible for controlling that the label affixed to the bottle correctly established the appropriate dose for the plaintiff's son, as it is part of the functions that correspond to them as pharmaceutical professionals, according to the indicated manual and the internal procedure established at the hospital. Having failed in that control duty, since the medicine bottle was delivered with an incorrect dose, the defendants are strictly liable for the death of the minor [Name4]</span><span style=\"-aw-import:spaces\">&#xa0;&#xa0; </span><span>."</span></p><p style=\"margin-top:0pt; margin-bottom:0pt; font-size:14pt\"><span style=\"font-weight:bold\">&#xa0;</span></p><p style=\"margin-top:0pt; margin-bottom:0pt\"><span>&#xa0;</span></p></div></body></html>"

“VI.- ANALISIS PREVIO ACERCA DE LA RESPONSABILIDAD CIVIL. Una vez resuelto el aspecto citado, de previo a conocer el resto de los agravios de fondo, conviene referirnos al tema de la responsabilidad civil y su evolución en el marco de la llamada responsabilidad objetiva. A través de la historia y de la enseñanza del derecho se ha impulsado la imagen de que la fuente de todas las instituciones jurídicas importantes se encuentra en el Derecho Romano, más específicamente en lo que se conoce como Derecho Romano del período clásico. La responsabilidad civil no escapa de esta visión. Así autores como Diez Picazo y Ponce de León establecen que la semilla inicial de la responsabilidad civil se encuentra en tal derecho. Analicemos el por qué. Según lo establecen tales autores, la posibilidad de solicitar un resarcimiento civil en Roma surge dentro del ámbito de la acción delictiva. Así por ejemplo, se relacionaba la acción civil con el “furtum”, que era una acción de naturaleza penal que se ejercitaba con ocasión de infracciones a los derechos o a una cosa. Por otro lado, otra acción era la “damnun innuria datum” la cual gracias al Tribuno Aquilino, dio origen a la llamada “Lex Aquilia”. Dentro de las normas más importantes de dicha ley tenemos la posibilidad de solicitar un resarcimiento ante la pérdida de los esclavos o de algún cuadrúpedo, por lo que, definitivamente, dicha acción deriva de un daño material causado (Digesto 9, 2, 2). Otro elemento importante para la evolución de este tipo de acción civil lo constituye el derecho pretoriano, dada que por su naturaleza era un derecho menos formal y en que la equidad comienza a tener un contenido importante, a fin de determinar la naturaleza y cuantificación del daño. En el marco de estas fuentes normativas podemos concluir que en el Derecho Romano “clásico” existían las siguientes acciones: 1. Acciones ante la lesión o destrucción de las cosas, esto daba pauta para ejercer la llamada “inuiria” que era una acción ejercida siempre y cuando existiera un nexo causal con el daño. 2. Acciones por lesiones corporales y daños causados a la persona. 3. Acciones por daños causados por animales o por negligencia de la persona (por ejemplo, daños al cabalgar). 4. Acción de dolo, o sea haber actuado con intención de generar un daño. 5. Por último, la “inuiria” evoluciona hasta convertirse en una acción que tutela los derechos de la personalidad, pero también sigue tutelando infracciones al derecho de posesión y de propiedad. Posteriormente, la influencia de los glosadores y de los comentaristas iusnaturalistas, resulta determinante dentro de la evolución de la responsabilidad civil, principalmente por dos aspectos. El primero radica en el hecho de que se amplía el espectro de la responsabilidad ante situaciones generadas ya no solo por la persona que causa el daño, sino también ante actuaciones desplegadas por los o las sirvientes, los cuales generaban la responsabilidad de su amo o ama –inicios de la culpa “in vigilando”-. El segundo aspecto tiene que ver con la legitimación para cobrar el resarcimiento, debido a que esta etapa se permitía que los herederos o las herederas de la víctima cobraran indemnizaciones ante la muerte, tal y como podrían ser los alimentos. Dentro del marco evolutivo de la responsabilidad tiene una importante influencia autores como [Nombre1] y [Nombre2], los cuales conformaban la Escuela Naturalista que influye en el Code. El aporte del primero de ellos consiste en derivar la acción civil de un hecho “ilícito” que podía ser ocasionado con dolo o por actuar culposo o negligente. Bajo esta misma línea, [Nombre2], clasifica los tres tipos de causas de las que podrían derivarse el derecho a solicitar un resarcimiento, entre éstas tenemos, los cuasicontratos, los incumplimientos contractuales y los crímenes o delitos. La influencia de estas escuelas determina que el año 1792 se estatuya en el Código Prusiano una norma que establece lo siguiente: “Todo daño causado por dolo o por negligencia grave que genere una enfermedad personal grave o la muerte debe ser punible”. También el Code toma esta misma orientación al establecer: “Artículo 1382. “De los delitos y cuasidelitos. “Cualquier hecho del hombre, que causa a otro un daño, obliga a repararlo a aquél por cuya culpa ha ocurrido”.”Artículo 1383. Es responsable no solo del daño causado por hecho propio, sino también por el hecho de las personas que deba responder o de las cosas que uno tiene bajo su guarda”. Evidentemente, toda esta codificación tiene una influencia en nuestra normativa nacional. Basta hacer lectura del numeral 1045 del Código Civil para percibirlo, no obstante es necesario destacar cómo la perspectiva acerca de la naturaleza de la responsabilidad civil no puede agotarse tan solo dentro de esta norma. La norma en cuestión parte, al igual que la legislación Napoleónica, de un actuar ya no solo doloso sino también negligente e imprudente de parte de la persona agente que genera el daño. También como fruto de los momentos históricos y sociales que rodeaban a Francia en el siglo XVIII, se parte de una relación individualista entre la persona agente y la víctima, dado que ni siquiera en la mentalidad del Poder Legislativo de esa época se valoran los efectos de la teoría del riesgo propia de la actividad industrial o comercial en masa. Debemos recordar que en el año 1804, en Francia, lo que se desarrolla es una economía agrícola o artesanal, por lo que era difícil prever los cambios introducidos por la Revolución Industrial. Otro aspecto importante para explicar la normativa de la cual deriva la nuestra, es la importante influencia que tiene el Derecho Canónico. Evidentemente, normas como el artículo 1045, parten de una premisa de la que deriva la obligación de la víctima de acreditar cuál fue la persona que generó la acción dolosa o culposa que a fin de cuentas causó el daño. Cuando la víctima se encontraba ante supuestos en los que no podía acreditar estas situaciones, ya sea por falta de prueba o dificultad de conseguirla –debido a la imposibilidad de conseguirla de parte del agente-, se indicaba que estábamos en presencia de “actos de Dios” de aquéllos que se ejecutaban como castigo ante la víctima, por lo tanto no resarcibles. De esta manera el resarcimiento del daño era visualizado como el “pago de un pecado” y no como una indemnización para la víctima. En síntesis, los criterios de imputación subjetiva conllevan que la carga de la prueba del dolo o la negligencia o la imprudencia corresponda a la víctima, lo cual en nuestra sociedad actual es muy difícil, debido al desarrollo socio-económico de las empresas y al crecimiento acelerado del Estado. Analicemos bien esto. En los últimos doscientos años, el mundo ha experimentado una acelerada evolución, por lo que las relaciones sociales se han tornado muy complejas. Dicha complejidad trae como consecuencia una mayor posibilidad de generar daños, antes inimaginables, producto del desarrollo científico y tecnológico, que son producidos ya no solo por el crecimiento de las empresas sino también por el Estado y sus instituciones como entidades que se relacionan con personas que acuden ante ellas para consumir un bien o un servicio. En el caso de los servicios estatales tales como salud, educación, seguridad ciudadana, servicios de banca, etcétera, existe una actividad eminentemente riesgosa que resulta propensa para la producción de daños. Bajo esta línea de pensamiento, se hizo necesario brindarle a la persona consumidora de esos bienes o servicios una protección especial ante esos posibles daños, a través de un régimen de responsabilidad civil visualizado desde una nueva perspectiva que rompiera el principio general de la imputación subjetiva, para adecuarse a las exigencias impuestas por la transformación de las realidades sociales. Y es que esas realidades provocan que, debido a la estructura en la división de los trabajos que se ejecutan, cuando ocurre un daño en perjuicio de la persona usuaria es muy difícil para ella endilgar ese dolo o la negligencia a alguna persona empleada o funcionaria específica, toda vez que en la prestación de un servicio o en la fabricación de un bien intervienen múltiples agentes, lo que en muchas ocasiones puede llevar a una denegación de la justicia. Es por esto que, ante la imposibilidad de la persona usuaria o consumidora de demostrar la existencia de culpa; la mayoría de los ordenamientos jurídicos modernos optan por un sistema de responsabilidad civil de naturaleza objetiva, que atiende esencialmente a la producción del daño, con independencia de que haya mediado culpa o dolo en la comisión de éste. Por ende, la persona causante del hecho dañoso, solo puede eximirse si logra demostrar que no existe un nexo causal entre la conducta que genera el daño y éste. Asimismo, existen mecanismos que garantizan la posibilidad de extender la responsabilidad generada por el daño ya no solo a las empresas o a las entidades estatales, sino también a las personas empleadas o a las funcionarias que participan en la prestación del servicio o en la elaboración del producto. Como ejemplos de estas normas que fijan criterios de imputación objetiva tenemos el numeral 190 de la Ley General de la Administración Pública y, más recientemente, el artículo 35 de la Ley de Promoción de la competencia y de defensa efectiva del Consumidor, las cuales, como explicaremos no resultan excluyentes entre sí. “VII.- EL NUMERAL 35 Y SU APLICACIÓN EN EL CASO DE LA CAJA COSTARRICENSE DEL SEGURO SOCIAL. El artículo 190 supra citado constituye una norma que, en forma general, se utiliza para aplicar un criterio de imputación objetiva en el caso de responsabilidad civil del Estado y sus instituciones. La norma señala “La Administración responderá por todos los daños que cause su funcionamiento legítimo o ilegítimo, normal o anormal, salvo fuerza mayor, culpa de la víctima o hecho de un tercero.” Dicha norma tiene la particularidad que solo permite exigir un resarcimiento a la administración estatal, más no a las personas servidoras públicas que se vieron involucradas en la comisión del daño en perjuicio de la persona usuaria. No obstante, esa norma no es la única que permite extraer este tipo de responsabilidad objetiva, sobre todo a partir de la entrada en vigencia en nuestro ordenamiento del numeral 35 de la ley de promoción de la competencia y defensa efectiva del consumidor. El primer párrafo de ese numeral establece “El productor, el proveedor y el comerciante deben responder concurrente e independiente de la existencia de culpa, si el consumidor resulta perjudicado por razón del bien o el servicio, de informaciones inadecuadas e insuficientes sobre ellos o de su utilización y riesgos. Sólo se libera quien demuestre que ha sido ajeno al daño. “ (Lo destacado y subrayado es nuestro). Por otra parte, el numeral 2 de la misma ley define al proveedor como “Toda persona física, entidad de derecho o de derecho, privada o pública que, en nombre propio o por cuenta ajena, se dedica en forma habitual a ofrecer, distribuir, vender, arrendar, conceder el uso o el disfrute de bienes o a prestar servicios sin que necesariamente ésta sea su actividad principal…” (Lo destacado es nuestro). De la lectura de este párrafo es posible concluir que la Caja Costarricense de Seguro Social es una entidad pública proveedora de bienes y servicios a sus usuarios y usuarias, a la que le es aplicable la responsabilidad civil derivada del numeral 35. Sin embargo, a diferencia del 190, dicha responsabilidad no se agota con la entidad pública proveedora, sino que se extiende, de forma solidaria, a cierto tipo de personal especializado que labora en ella. Al respecto, el párrafo 2° del 35 dispone que “…Los técnicos, los encargados de la elaboración y el control responden solidariamente, cuando así corresponda por las violaciones a esta ley en perjuicio del consumidor”. En este supuesto, esta categoría de trabajadores o de trabajadoras, debido a sus funciones particulares, puede imputárseles responsabilidad en el supuesto de un daño causado a la persona consumidora o usuaria, ya sea con ocasión del bien o servicio brindado, o por informaciones inadecuadas o insuficientes respecto de éstos o de su utilización y riesgos. Específicamente, en el caso de las personas encargadas del control de los bienes y servicios, se refiere a aquéllas cuya función es la de verificar que se han cumplido todos los procedimientos establecidos para garantizar la seguridad y la eficiencia en el servicio ([Nombre3] , . “La responsabilidad civil por productos en México, Canadá y Estados Unidos”, 2001). VIII.- LAS ACCIONADAS EJERCÍAN CONTROL SOBRE LAS RECETAS QUE SE DESPACHABAN EN EL HOSPITAL. Una vez que hemos expuesto lo anterior, es momento de hacer un breve esbozo de las situaciones esenciales de este caso. En los autos ha quedado acreditado que, el veintiséis de enero del dos mil, el menor (de pocos días de nacido) [Nombre4] , fue ingresado en el Hospital de San Rafael de Alajuela, ya que sufría de crisis de cianosis generalizada. En ese momento, debido a la crisis convulsiva que presentaba, se le trató con valproato de sodio, quedando internado hasta el día nueve de febrero del dos mil. En esa fecha se le dio de alta, sin embargo, se recomendó seguirle aplicando el medicamento dicho, por lo que, se emitió la correspondiente receta médica, la cual le fue despachada, junto con las indicaciones de dosis de aplicación por parte de las personas que laboraban en la farmacia del hospital y se le entregó a la aquí actora, como madre del niño. Para esa época, la aquí actora apenas tenía quince años de edad. En esa fecha, las aquí demandadas [Nombre5] , [Nombre6] , [Nombre7] y [Nombre8] , desempeñaban el cargo de farmacéuticas del hospital y tenían la regencia compartida de siete de la mañana a diez de la noche. En la etiqueta rotulada en el frasco de valproato de sodio se indicó por error que el menor de edad debía de consumir “tres goteros” al día por la vía oral y no tres gotas como, en realidad, era lo correcto, de acuerdo a la dosis recomendada para una persona menor de esa edad. Al retirar el medicamento, la accionante, se devolvió con la finalidad de aclarar la dosis que debía ingerir el menor, pero no fue atendida, por lo que, le hizo tomar a su hijo los tres goteros del medicamento. Debido a esto, el once de febrero del mismo año, el niño sufrió una reacción y fue llevado por su abuela al mismo hospital donde fue internado y se le remitió posteriormente al Hospital de Niños donde, finalmente, murió el veinte de febrero, como producto de la intoxicación con valproato de sodio, lo cual también le generó daño agudo cerebral (encefalopatía hipóxica) y fallo multiorgánico. Evidentemente uno de los aspectos esenciales del proceso gira en torno a la responsabilidad de las demandadas, como farmacéuticas, encargadas de controlar las indicaciones de las dosis que debía de ingerir el niño [Nombre4] . Como ya explicamos anteriormente, dicha responsabilidad se asigna con base a criterios de imputación objetiva (con fundamento en el artículo 35 ibídem), dado que fue como consecuencia de una información incorrecta contenida en el frasco de medicamento lo que llevó a la adolescente madre a darle una dosis fatal que acabó con la vida de su bebé. En este sentido, existe en el expediente amplia prueba documental que demuestra las funciones de control y supervisión que, debido a su cargo, estaban obligadas a desempeñar las accionadas. Primeramente, el Manual de Organización y Funcionamiento Administrativo de Farmacias de la Caja Costarricense del Seguro Social (folios 384 a 445), en su capítulo XV establece todo un procedimiento para el recibo y retiro de medicamentos en los servicios de hospitalización. Ahí se especifica que es el médico o la médica quien emite la receta para el o la paciente, que posteriormente es enviado a la farmacia para la obtención de medicamentos (folio 443). Ya en la farmacia las recetas son recibidas por una persona funcionaria, quien anota la hora y fecha de recibidos (artículo 52, folio 443) y luego las recetas, junto con el expediente médico, se le entregan al o a la farmaceuta para que efectúe una REVISIÓN INICIAL (artículo 52, folio 443). El artículo 53 establece que la revisión técnica de la receta debe ser hecha por una persona profesional en farmacia, quien debe fijarse que se encuentre incluido el perfil terapéutico, puesto que, de lo contrario, se le incluye un perfil nuevo. Una vez hecho se remite al área de etiquetado, en donde se rotulan las medicinas a máquina o por un medio automático; dichas etiquetas deben contar con la siguiente información: servicio de hospitalización, nombre del o de la paciente, nombre del medicamento, potencia, DOSIS, cantidad, fecha e indicaciones especiales (numeral 54). De ahí se pasan al área de alistado de recetas, donde una vez que se tienen los grupos de recetas listos con respectivas etiquetas, se colocan en la mesa de REVISIÓN FINAL (artículo 55). Dicha REVISIÓN FINAL es realizada por la persona farmacéutica a quien le corresponde revisar que la receta está preparada correctamente y que las indicaciones de las etiquetas estén bien, se pega la etiqueta, luego los medicamentos junto con la receta se pasan al área de entrega de medicamentos (artículo 56). Dichas normas son claras en cuanto a establecen la responsabilidad de las farmacéuticas, como personal técnico, de controlar todo el procedimiento de entrega de los medicamentos y elaboración de las etiquetas respectivas con la indicación de las dosis que deben tomar las personas usuarias del servicio. Por si eso no fuera poco, en el propio Hospital en el que laboraban las demandadas, tenía todo un procedimiento técnico establecido para el departamento de farmacia (folios 446 a 481). Dicho procedimiento, al igual que el manual supra citado, indicaba que la revisión inicial de la receta médica correspondía a la persona farmacéutica, cuyo deber es el de interpretar la receta administrativa, técnicamente, efectuando cualquier aclaración necesaria (folios 466). También corresponde a dicho o a dicha profesional, establecer las instrucciones requeridas para la rotulación y cantidad a dispensar y enviarla al sistema de cómputo. En el caso, de que la receta no cumpla con los requisitos administrativos o técnicos, como podrían ser: datos personales, letra legible, dosificación, potencia, días de tratamiento, vía de administración, agotado o medicamento no oficial, interacción de medicamentos, etcétera; deberá DEVOLVER la receta al médico o a la médica a registros médicos, a través del paciente o con personal técnico de la farmacia de ser posible (folio 467). Así las cosas, las demandadas como farmacéuticas que se encontraban en turno el día que fueron despachados y entregados a la aquí actora, eran responsables de controlar que la etiqueta adherida al frasco cumpliera con establecer la dosis adecuada para el hijo de la actora, pues es parte de las funciones que como profesionales en farmacéutica les corresponden, de acuerdo al manual indicado y al procedimiento interno establecido en el hospital. Al haber incumplido esa labor de control, puesto que se entregó el frasco de medicina con una dosis incorrecta, las demandadas son responsables, objetivamente, por la muerte del menor [Nombre4] .”