The authors declares that there is no conflict of interest.
Henrique Nicola Santo Antonio Bernardo (1)
Maria Clara Cardoso Seba (1)
Julia Ribeiro Targa de Lima (1)
Nathália Molleis Miziara (2)
Carmen Sílvia Molleis Galego Miziara (3)
Ivan Dieb Miziara (3)
(1) Faculdade de Medicina do Centro Universitário ABC, Santo André, SP, Brasil (main author).
(2) Universidade de São Paulo, São Paulo, SP, Brasil (main author).
(3) Faculdade de Medicina do Centro Universitário ABC, Santo André, SP, Brasil (supervisor).
The objective of this study was to show the main aspects related to medical responsibility. To achieve that purpose, a literature review was conducted. Results: The patient should always be the center of the doctor’s attention, that is, medicine must be humanistic. It is not possible to approach humanism without strictly following ethical principles of the profession. However, medical liability is not restricted to ethical issues, but also legal. The culpable conduct (negligence, recklessness, and lack of ability) causes damage to the patient and, if there is a link between these two aspects, configures responsibility. Any medical action requires diligence, care and skill. If there was carelessness, then the defendant-physician is liable. The law requires a physician to possess the skill and knowledge which the average member of the medical profession possesses. The physician is not liable for any error, provided he does what he thinks is best after a careful examination. A good result is not a guarantee.
Keywords: damage liability, contract liability, liability Legal, ethics professional, code of ethics.
The choice of the medical profession requires responsibility, competence, conscience, and prudence. The medical doctor must act according to ethical and moral principles (1,2).
Altruism, integrity, honesty, veracity, and empathy are attitudes necessary to good medical practice, being fundamental factors for strengthening the doctor-patient relationship (3).
The commitments made by doctors are not limited to ethical issues, but require actions compatible with legal norms, that primarily target the interests of patients and the community (4).
According to Alexander Lacassagne, cited by Fávero (1991), medical responsibility is the “obligation for doctors to suffer the consequences of misconduct committed by them in the exercise of art, professional misconduct that can lead to double civil and criminal prosecution” (5), to this context, we should add the ethical sanctions from professional malpractice.
França (2014) stated that medical activity is the most vulnerable of all professions, and due to the large number of lawsuits filed by patients against doctors, it would be “seriously threatened” (6).
The doctor must be aware that his actions are potentially capable of generating judicial and/or extrajudicial claims. Therefore, must take the necessary measures to avoid conflicts with ethical and legal standards.
This study aimed to show the main aspects related to medical responsibility, including its possible consequences in the judicial and extrajudicial spheres, based on historical landmarks.
2. MATERIAL AND METHODS
This study was conducted through an integrative literature review with a search for materials in scientific articles available in open-access databases, laws, resolutions of the Medical Councils, and books. The descriptors used were Damage Liability; Contract Liability; Liability, Legal; Ethics, Professional; and Code of Ethics. No search time was established.
3. RESULTS AND DISCUSSION
3.1 HUMANIZED MEDICINE AND THE MORAL OBLIGATION OF THE DOCTOR
Asclepius is a hero and god of medicine in ancient Greek religion and mythology, he had the gift of healing as well as bringing the dead to life. In the other hand, Hippocrates, a philosopher known as the father of medicine, showed the importance of loving the master and his teachings, as well as the patient. Hippocrates taught that in medicine the focus is on the patient, without focusing exclusively on the disease, but placing the human being with all his singularities in the center of attention.
The Ethics and humanism linked by empathy and compassion are fundamental pieces for the base of the physician’s moral obligations. In 1919, shortly before being victimized by the Spanish flu pandemic, William Osler, father of humanistic medicine, summed up medicine in two words: phylotechnics and philanthropy. The first expressing the love of art and the second the love of humanity. Osler referred to the words assigned to Hippocrates centuries before(7).
Historical dates suggested that the forerunner of humanistic medicine is Scribonius Largus, doctor of the emperor Claudius. He lived in the first century after Christ, who, besides being an expert in pharmacology, recognized Medicine as a profession in the sense of vocation, with moral obligations, he quoted “good man, an expert in healing, full of mercy and humanity”, emphasizing the need for compassion and kindness for the perfect exercise of this art (8).
3.2 PHYSICIAN’S MORAL OBLIGATIONS AND THEIR CONSEQUENCES – HISTORICAL DATA
Medicine is as old as humanity, but the first reference to medical responsibility dates from 2030 B.C., with the Hammurabi Code which adopted the principle of reciprocity “eye for an eye, tooth for a tooth” (9).
The punishment given to the doctor for the negative result was proportional to the degree of damage caused or the social importance of the patient. In the 5th century, in Rome, the Law of the Twelve Tables determined the monetary compensation to the victim for the damage caused by the professional, as stated in Table VII, referring to the Hamurabi Code: “If someone hurts another, let him suffer the penalty of Talion, unless there is an agreement” (10).
The lex Aquilia,also called Aquillian law, was a Roman law (3rd century B.C.) that provided financial compensations for damage, launching a type of non-contractual liability. However, the law required the link establishment between the agent’s act and the bad result (injury) (11).
Medical responsibility and morality are demonstrated in the Hippocratic Oath, dated 400 BC, and represents a document of extreme importance and delicacy, bringing as central axes the love for the masters and the extreme dedication to the patient and not to the illness itself, also emphasizing the universal and timeless moral values necessary for medical practice (12).
For bioethicist Diego Gracia, the oath “composed in the fourth century B.C., has been the model of professional ethics throughout Western culture (13).”. According to Garcia, the core of the Hippocratic Oath is the professionals have to “aspire to excellence, and anything beneath this should be considered insufficient by definition”.
This, in our view, also implies responsibility – since at the end of the oath the doctor assumes to answer for all his acts: “If I fulfill this oath with fidelity, may I be happily enjoying life and my profession, honored forever among men; if I depart from or violate it, the opposite will happen.”.
Extreme measurements adopted against the negative outcome of medical treatment emerged between the 4th and 5th centuries A. C. The Ostrogoths and Visigoths granted the family of the patient the authority to apply the penalties to the doctor once they had faced unsatisfactory results (14).
In the 18th century, the emblematic case led by Dr. Hèlie ocurred in 1825, in France, doctor Hèlie penalized to compensate monetarily the patient who had her arms amputated during a difficult birth. In that judgment, the reason that led the doctor to extreme medical conduct was not considered (15).
Another symbolic case that ended with the sentence pronounced on June 18, 1935, by the Attorney General of France, Dr. André Marie Jean-Jacque Dupin, was the one referring to the amputation of an arm resulting from a medical action, bleeding, and negligence, characterized by the failure to follow up the patient’s clinical evolution.
Doctor Thouret-Noroy was hold civilly responsible for the unintended bad medical outcome. In the referred jurisprudence, Dupin instituted the doctrine of medical responsibility, quoting: “for there to be a civil liability, it is not necessary to specify if there was an intention; it is enough that there was negligence, recklessness, gross malpractice and, therefore, inexcusable.”. Continuing, Dupin emphasized: “in responsibility, as can be understood from civil law, is not a matter of capacity, more or less ample, or of talent more or less brilliant, or more or less solid, however, only the guarantee against recklessness, negligence, haste is a gross ignorance of what is necessarily required” (6).
In Brazil, the first legal norm about medical liability in the criminal sphere dates from 1890, articles 297 and 306 of the Penal Code (16):
Art. 297. Anyone who, for recklessness, neglect or malpractice in their art or profession, or for non-observance with any regulatory provision, commits or for involuntary cause, directly or indirectly of homicide, will be punished with cellular imprisonment for two months to two years.
Art. 306. Anyone who, due to recklessness, neglect, or non-observance of any regulatory provision, commits or for involuntary cause, directly or indirectly, of any bodily injury, will be punished with a cell prison sentence of fifteen days to six months.
In addition, the first civil legal determination regarding the obligation to repair damages due to culpable acts dates back of 1916 in the Civil Code of the United States of Brazil (17):
Art. 1,545. Doctors, surgeons, pharmacists, midwives, and dentists are obliged to satisfy the damage, whenever recklessness, negligence, or malpractice in professional acts result in death, disqualification from serving, or injury.
After the end of the Second World War in 1947, Nazi doctors were brought to trial in Nuremberg (Bavaria), accused of practicing clinical experiments on human beings in absolutely cruel and inhumane ways. This trial resulted in the Nuremberg Code, published in 1949, which exalted the respect for the autonomy of the research participant (18).
The Nuremberg Code, however, was ignored by American researchers who maintained the practice of research on vulnerable human beings without the participant free consent. In 1964, at a meeting in Finland, the World Medical Association drafted the Declaration of Helsinki, determining the ethical guidelines for clinical research involving human beings.
After a series of updates, the Declaration of Helsinki persists as a basic source for the construction of the term of informed consent and standards of good practice in clinical research. It represents the gold standard in medical practice and medical research involving the human; it promotes and safeguards the health, well-being, and rights of patients, including those who are involved in medical research (19).
Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights, however, in the United States of America, nowadays, medical researchers continued to carry out experiments with human beings without ethical criteria established by the Declaration of Helsinki. Henry Beecher, an anesthesiologist at Harvard, in 1966, published an article in the New England Journal of Medicine exemplifying 22 clinical trials conducted by American researchers without any ethical criteria. In these examples extracted from the article, the participants were patients in situation of vulnerability who did not give consent (20).
An iconic clinical trial was the Tuskegee experiment, in Alabama, United States of America. The research lasted 40 years (1932 to 1972) and aimed to monitor the natural history of syphilis. The study included 600 black and poor men living in the state of Alabama (399 patients and 201 controls) who served as human “guinea pigs” for the research team. It should note that the referred study did not obtain acceptable scientific results and developed in an expendable way since previously scientific research had been with 2,000 people with the same purpose published in Norway (21).
Two other American experiments also shocked the medical community and society. The first study, in 1963, was injected with cancer cells in elderly patients. The second study, known as the “Willowbrook Case”, lasting 20 years (1950 to 1970), intentionally contaminated people with disease or mental disability with the hepatitis virus (22).
In this devastating scenario, from an ethical and human point of view involving doctors, Van Rensselaer Potter published, in 1971, the book Bioethics: Bridge to The Future, starting the process of bioethics and opening margins for discussing of ethical dilemmas and problems, developing integrative reasoning between human beings and the environment. However, Potter’s globalized view of bioethics was not at first incorporated by society or the scientific community (23).
Herman Tristram Engelhardt Jr. said, “There is no moral of universal content”, refuting this idea (24,25).
Furthermore, in 1978, the Belmont Report published, containing three basic ethical principles guiding modern bioethics: the principle of respect for people, the principle of beneficence and the principle of justice.
The following year, Tom Lamar Beauchamp and James Franklin Childress, based on the ethical-deontological and consequentialist theories of William David Ross and William Frankena, in addition to the Belmont Report (Loch, 2002), unfolded the principle of beneficence in beneficence and non-maleficence. The authors published the book Principles of Biomedical Ethics (26).
From the 1970s onwards, bioethics gained strength in the United States and reached Europe in the following decade. In Brazil, the strong presence of bioethics occurred in the year 1990. Since then, bioethicists and scholars have dedicated special attention to this science, awakening in the medical community an increasing respect for the ethical standards of the profession.
The Hippocratic Oath has a paternalistic context, the doctor was the holder of knowledge, not giving the patient the possibility to question or express an opinion on his treatment. Nowadays, medicine is no longer paternalistic, conferring on the patient the autonomy to decide on the diagnostic investigation and the treatment to instituted, emerging this way the shared medicine.
Society now has greater access to information and means to claim its rights in the face of alleged medical malpractice. As Lisboa et al. (2010) explains, “The doctor previously seen by society with remarkable respect now becomes a service provider, according to the Consumer Protection Code. The relationship with his patients, previously based on trust, is now governed from the contractual point of view.” (27).
3.3 CONTRACTUAL AND NON-CONTRACTUAL RELATIONSHIPS BETWEEN DOCTOR AND PATIENT
Medical liability is always personal and can not be presumed; the doctor’s guilt needs to be proven (28), therefore, this responsibility based on four pillars: the physician’s action or inaction; guilt or willful; causality relationship; and harm to the patient (29).
In the professional performance, the doctor should not promise results, as well as should not assign fees to the result of the treatment or the cure of the disease (Article 62 of the medical code), he should only commit himself to offer the patient all the resources that are possible and available to achieve the success of the treatment. The professional’s responsibility also conditioned to the type of contract established in the provision of services (28).
For Soares, the results do not depend only on the doctor’s skills, influenced by multiple factors such as the severity of the condition, adherence to the guidelines, “anatomy functional and psychic peculiarities” of the patient and the occurrence of adverse events, in other words, unintentional facts (30). The circumstances involved in which the medical act took place, and the degree of predictability should be considered (6).
Therefore, the consideration as to the physician’s obligation to be middle or end (results) needs clarity. For França (2014) the obligation of a means would be that “there is a commitment to use all available resources to achieve a result, without, nevertheless, the obligation to achieve such a legitimate success”. The author adds that all medical actions aim at good results, but when this does not occur in the absence of guilt, there is no question of liability. In contrast, the obligation at last, as the name itself clarifies, would be the promise of result (6).
The relationship between the doctor and the patient stops being contractual when the service has taken place in any urgent or emergency situation in which the patient or his legal guardian has not chosen the professional. When the patient seeks service in a certain public or private institution, thus, the exceptional contractual conditions regarding medical responsibility are still subjective; therefore, it depends on the demonstration of the guilt of the professional, so that the duty of reparation is recognized.
Any medical action is necessary the ordinary diligence, care, and skill, or if there was carelessness, then the defendant-physician is liable. The law requires a physician to possess the skill and learning which the average member of the medical profession possesses. The physician is not liable for a mere error in judgment, provided he does what he thinks is best after a careful examination. He does not guarantee a good result (31).
3.4 CRIMINAL LIABILITY OF THE DOCTOR
The medical act adjusted must be to ethical and legal principles, acting with respect and humanity, having as its main object the protection of the patient and the community. According to the General Medical Council, the expected behavior of the doctor is supported on four domains: knowledge, ability and performance; safety and quality; Communication, partnership, and teamwork; and maintenance of trust (32).
The right to life is an inviolable asset, under the terms of Article 5th of the Brazilian Federal Constitution, and must be protected mainly by the doctor, who will be held responsible for proven bad practice (authorship and materiality), therefore, when he acts culpably, causing the bad result by negligence, recklessness or malpractice, or when he acts fraudulently, acting with the intention of obtaining the result or taking the risk of producing it (16). As an example of a felonious crime, we can cite the practice of abortion in non-exclusive conditions provided by law (“if there is no other way to save the pregnant woman’s life or if the pregnancy is the result of rape”), so the medical act objected to the result, which in the case was the elimination of the concept.
The crime is understood analytically as a typical, anti-legal, and culpable action. The physician may be hold responsible for his acts in the criminal sphere, undergoing criminal sanctions that may include payment of fines, restrictive penalties, or deprivation of liberty, depending on the degree of the injury caused, according to the magistrate’s understanding, based on safeguarding social interests.
Among the common crimes that may be committed by the doctor in his professional activities is the claimed medical error, which may be analyzed through the framework of the criminal types provided in articles 121 and 129 of the Criminal Code (1940). As for the crimes proper to the doctor, also established in the Criminal Code, there is the violation of professional secrecy, the omission of compulsory notification, the falsity of the medical certificate, the omission of medical assistance and the illicit practice of the profession (16).
Another possibility of a medical crime was included in the criminal misdemeanor Law, article 66, and item II, which established the medical obligation to communicate the competent authority in “crime of public act of which he knew about in the exercise of public service, provided that the criminal action does not depend on representation and the communication does not expose the client to criminal procedure” (33). More recently, Law No 13,931 (2019) established the obligation of immediate compulsory communication, that is, in 24 hours, to the police authority of a suspected or confirmed case of violence against a woman without specifying the type of violence (34). Therefore, it may include the sexual crime that, since 2018, with Law No 13,718 which made the nature of the criminal action of crimes against sexual freedom and of sexual crimes against vulnerable public and unconditioned, revoking the provision of Decree-law No. 3,688 of October 3, 1941 (Law of Criminal Misdemeanor) (35).
Regarding the criminal responsibility of the physician, the wide sense of guilt must always be demonstrated (sensu stricto guilt or malice), and it is not possible to have a criminal sentence without the proof of this subjective element (the agent did not want the negative outcome or the risk, there being only the predictability of the damage); thus, the fulfillment of the technical standards of the profession is a fundamental element to “avoid damages to the protected legal assets” (6).
3.5 PHYSICIAN’S LIABILITY
Life is an inviolable asset to be protected, as established in article 5 of the Constitution (36), in the Hippocratic Oath and the Medical Code of Ethics (37).
The obligation of the physician to repair the damages caused to the patient, by means of a culpable action, committed by negligence, recklessness and/or malpractice, from which material damage (patrimonial) or moral (off-balance sheet) resulted, arises from the general clause of responsibility for guilt, stated in art. 186 of the Civil Code (38), as well as art. 14, § 4 of the Consumer Defense Code (39). In this aspect, it is clear the need for the existence of a causal link between the doctor’s wrongful action and the damage suffered by the patient, being necessary the compensation (38,39).
The occurrence of a bad result does not necessarily imply a culpable action on the part of the doctor. The unpredictable and unavoidable situations are examples of this condition, as it occurs in anatomical variations or anaphylactic shock by the use of medication. When the bad result comes from a predictable and inevitable condition, it is necessary to analyze if the patient’s autonomy in the face of risk has been respected, otherwise the doctor may be held responsible. In predictable and avoidable situations, it is evident that the unfavorable outcome resulted from the professional’s culpable action. Consequently, according to the aforementioned article 186 of the Civil Code (2002) “Whoever, by voluntary action or omission, negligence or recklessness, violates the law and causes damage to another, even if exclusively moral, commits an illicit act” (38).
In civil liability there are subjective theory and objective theory. In subjective theory, guilt is an intrinsic component of the illicit act. This theory is applied in the criminal doctrine, understanding that the agent, in this case the doctor, did not desire the result and did not take the risk of causing the harm. Due to the unpredictability of the damage, subjectivity is established, making it difficult to establish the criminal responsibility of the physician (6,39).
In the consumer defense code, in objective theory, guilt is not necessary, since the agent assumed the risk of the damage caused and must, therefore, repair, no matter if there was or not the intention. In this case, there was the presumption of guilt, since it is based on the “assumption of unequivocal responsibility, not on the need to establish guilt” (40).
According to Law 8078 of 1990, objective responsibility is applied to all service providers, regardless of the existence of guilt. However, still with regard to this law, doctors are excluded to the extent that the writing exposes: “with the exception of the liberal professional class, for carrying out their activities mainly as being of means and, therefore, considered subjective responsibility”, in accordance with the fourth paragraph of article 14 of the referred law (39,40).
3.6 ADMINISTRATIVE RESPONSIBILITY – ETHICS
Since the Hippocratic Oath, 400 B.C., until the present day, the medical performance is based on the ethical principles that govern the profession, especially when it comes to not causing harm to the patient. In 1774, Thomas Percival published the first known code of medical ethics. Since then, countries have adopted deontological and diceological criteria for the organization of the profession.
In Brazil, the Code of Medical Ethics, Resolution CFM No. 2,217/2018, maintains the obligation of the physician to obey the ethical precepts of the profession under penalty in case of noncompliance and establishes the imperative of responsibility as a way to ensure the prestige and credibility of the profession, with the physician acting with diligence, expertise and prudence (28).
According to Abreu (1998), “any intervention on the human person, his fundamental characteristics, life, physical integrity and mental health, must be subordinated to ethical precepts (41).”. Thus, according to the Medical Ethics Code, “the target of all doctor’s attention is the health of the human being, for the benefit of which he should act with the maximum care and the best of his professional capacity”, indicating alignment with the four fundamental principles of medical ethics: autonomy; beneficence; non-maleficence; and justice (28).
Upon denouncing an ethical infraction, the Regional Council of Medicine will follow the rite of fact-finding and judgment and, if justified, the establishment of a physician’s penalization, as provided in Law No. 3,268, 1957 (42), regulated by Decree No. 44,045, 1958 (43).
The rules of procedure, investigations, ethical-professional process, and the rite of judgment, to be followed by the Medical Councils are determined in the Code of Ethical-Professional Process, CFM Resolution No. 2,145 of 2016 (44). The penalties that may be applied to the doctor are five: a) confidential warning in a reserved notice; b) confidential censorship in a reserved notice; c) public censorship in an official publication; d) suspension of professional practice up to 30 (thirty) days; and e) termination of professional practice. As stated by the Federal Council, according to article 22 of Law No. 3.268, of September 30, 1957.
The physician’s actions must be guided in accordance with the ethical norms of the profession, established in the Code of Medical Ethics, which brings in its core the obligation of compassion and empathy, which are fundamental pieces for the exercise of humanized medicine. Certainly, the results will not always be satisfactory, considering the complexity of the profession, but the doctor who acts according to the ethical dictates will have enough elements to support his defense in case he is legally or ethically responsible for his acts. The responsibility of the doctor goes beyond the barrier of purely technical knowledge, advances in social, legal, moral and ethical issues. Knowing and exercising professional rights and duties is the centerpiece of the medical profession.
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