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The irrelevance of informed consent in the
medical liability lawsuit. An analysis of the
civilian and state experience in Colombia
La irrelevancia del consentimiento informado en los
litigios de responsabilidad médica. Un análisis de la
experiencia civil y estatal en Colombia
Jorge Enrique Cely León
Independent legal researcher
City:
Bogotá
Country:
Colombia
Original article (analysis)
RFJ, No. 11, 2022, pp. 63 - 119, ISSN 2588-0837
ABSTRACT:
This research provides a general review of medical
liability in the Colombian experience, specifically based on
the jurisprudence of the Civil Chamber of the Supreme Court
of Justice and the Third Section of the Council of State. All
the above, intend to raise a critique of the irrelevance of the
figure of informed consent in the liability trial, a matter that
reconsiders some of the basic assumptions for the emergence
of an indemnity obligation in the field of medical liability.
KEYWORDS:
Medical liability, Civil Law, Administrative Law,
Informed Consent.
RESUMEN:
Este artículo ofrece una revisión general de
la responsabilidad médica en la experiencia colombiana,
específicamente, a partir de la jurisprudencia de la Corte
Suprema de Justicia y del Consejo de Estado. Todo lo anterior,
para plantear una crítica a la irrelevancia de la figura del
consentimiento informado en el juicio de responsabilidad,
DOI 10.26807/rfj.vi11.367
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cuestión que replantea algunos de los supuestos básicos para
el surgimiento de una obligación indemnizatoria en materia de
responsabilidad médica.
PALABRAS CLAVE:
Responsabilidad Médica, Derecho Civil,
Derecho Administrativo, Consentimiento Informado.
JEL CODE:
H75, I18.
“There is no light without shadow in the human being”.
Carl Gustav Jung
INTRODUCTION
Civil and State liability, with its different developments,
regimes, and applications, is one of the broadest areas within
the legal world, which is only natural, since determining why
and to what extent damage is attributable to a subject requires
a judicious and detailed argumentative content, which for each
case is accompanied by several particularities (Mazeaud, 1983).
In fact, within this area, several sub-areas have been formed,
including medical liability (Giraldo, 2018, pp. 37-53).
Medical liability is an issue of great relevance in legal
terms, provided that, to date, it has managed to capture the
attention of two jurisdictions: the civil and the contentious-
administrative. From there, several rulings have been
issued that postulate jurisprudential lines in procedural and
substantive aspects.
However, the experience of each of the jurisdictions
has not been uniform, since there are several nuances in
this respect, so much so that the Supreme Court of Justice
considers that medical civil liability is contractual in origin,
but the Council of State considers that the medical liability
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of the State is non-contractual, matters that provide quite
different perspectives concerning the lawsuit that gives rise to
the indemnification obligation.
However, this is an issue that must be approached with
caution and attention, not only because the issues involved
are scattered in jurisprudence, laws, decrees, and resolutions,
but also because the profession of medicine and its practice is
related to the life and physical integrity of all persons who, at
any time, have required or will require health care services, be
they private or public.
Thus, the purpose of this journal article is to provide the
reader with a comparative analysis of the civil and administrative
experience in the field of medical liability, considering the most
important particularities that each of these offers. Now, given
that the complexity of the subject is considerable, we will first
deal with the medical-health activity as a case of civil and State
liability, and then make some criticisms about the irrelevance
of informed consent in the liability trial, a matter that questions
some of the fundamental assumptions of medical liability.
Before starting with the object of the journal article, it
is important to specify that the present work will start from
the assumption that the origin of a compensation obligation
comes from the proof of damage, imputation, and basis or
attribution factor. Where the first of these refers to the
affectation, patrimonial or extramatrimonial, suffered by a
subject. The second, imputation, is the relationship of causality,
factual or normative, that exists between the conduct of the
agent and the damage suffered by the victim. And finally,
the basis or attribution factor is the category that allows the
evaluation or qualification of the agent’s conduct, which can
be subjective or objective. The subjective factor consists of
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fault, which, in contractual matters, constitutes a breach and,
in non-contractual matters, the non-observance of an objective
duty of care, diligence, or expertise. Additionally, the objective
factor deals with the exercise of dangerous activities, which
is concretised by the execution of activities that increase the
normal levels of risk.
Having said the above, the present lines will set out the
main points that must be considered for an indemnity obligation
to arise in terms of medical liability, complemented by a critique
that seeks to reconsider some of the assumptions explained, to
offer effective protection to the right to self-determination of
all persons who seek health care services.
1. MEDICAL-HEALTHCARE ACTIVITY AS A CASE OF CIVIL
AND STATE LIABILITY
Within civil and state liability, few factual assumptions
have managed to encompass the multiplicity of debates that
medical-health activity generates and has generated. This
subject is worthy of work and development by the legal academy,
not only because of the large number of cases that are brought
before judges, magistrates, and councillors, but also because
of the significance and usefulness of the medical profession in
society. Thus, Liability Law aims to design models of justice
that respond adequately to the dynamics of medical services,
which, day by day, requires more sophisticated knowledge and
arguments to provide solutions to the legal problems generated
by the damage caused to pre-patients and patients, who are the
object of preventive, diagnostic and treatment measures.
In this section, we will study medical liability as
a special area within the law, which aims to correct, via
reparation and compensation (Díez-Picazo, 2001, pp. 312-
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314), those injustices produced by the activity of doctors and
health systems. Thus, for the present, the figure of the patient
gains indisputable relevance, since he is constituted, together
with his heirs - where applicable - as the direct victim of the
medical negligence, so that, in this case, he is the procedural
subject through which the trial of liability is triggered, which,
will always be the plaintiff. Now, the same does not happen
when we refer to the passive party of the litigation, since in the
case of Colombia, it may well be a health professional (general
practitioner or internist, surgeon, anaesthetist, nurse, etc.),
a Health Provider Institute (IPS), a Health Promoting Entity
(EPS)
1
or, in the case of State liability, a State Social Entity
(ESE) that directly provides the health service.
The main particularity that characterises medical
liability is that which is related to the practice of medicine itself,
understood as a professional activity that is regulated by the
legal system and whose purpose is, in general terms, to improve,
alleviate or cure the illnesses of human beings. However, this
does not indicate that the laws, decrees, or resolutions of the
health sector make it possible to conclude when a doctor, an
insurer, or a medical services entity is liable for an injury. The
difficulty of the issue lies in the imputation and the grounds or
attribution factors of the liability judgment.
Concerning imputation, the problem lies in something
quite evident, this has to do with the set of factual situations
that give rise to the damage, since in medical liability cases there
are always two conditions (Honoré, 2013, pp. 1075-1085) that
play the causal role: the illness and the doctor’s activity (Perin,
1
Regarding the regulation of health in Colombia, especially the
requirements for licensing, authorisation, and obligations of the entities
in the sector, it is important to review the regulations: Law 1164 of 2007,
the Single Decree 780 of 2018, and the Resolutions of the Ministry of
Health and Social Protection.
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2020, pp. 221-228). However, it is important to clarify that
this is a practical problem so that the doctrine has not created
new categories to talk about normative or causal imputation in
matters of medical liability, for which the traditional models
have been useful.
On the other hand, when it comes to the question of
the grounds or, as they are also called, attribution factors, the
professional fault is the central point of the problem, insofar
as patients, lawyers and judges do not have the necessary
knowledge to determine what is considered good or bad
behaviour in the medical profession, among other things,
because this is one of the most complex sciences within human
knowledge and it is developing day by day. As is the case in the
legal world, there may be different positions within medicine
as to the best treatment for a given pathology, as we all know,
medicine is not an exact science.
Now, to determine that a subject has acted with guilt, it
is indispensable to have an idea or concept of what is not guilty,
for which there are the archetypes of “a good father of a family”
or “a good businessman”, which provide a standard idea of
what is understood by care, diligence, prudence, and expertise.
However, guilt in the medical profession is not something that
is exhausted by an archetype; the technicality of the profession
requires a more sophisticated concept. For this reason, the
parameter of non-culpability in medical liability is to be found
in the
duty to be
of the professional technique, i.e., the
lex artis
,
from which it is possible to deduce the minimum level of care,
diligence, expertise, and prudence that any act of prevention,
diagnosis, and treatment must-have.
The
lex artis
is characterised by its dynamism, since
medical science, for each specific moment and case, may be
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different. For this reason, its study requires a retrospective
analysis that responds to the conditions of time, manner,
and place in which a certain medical service occurred, which
prevents the judge from considering a health professional or
entity negligent based on the scientific knowledge that arose
after the time when the facts occurred. Thus, the
lex artis
that is
studied in each case is known as
ad hoc
, which is composed of
the set of usages, customs, and practices applicable at a specific
time and individualised to the pathological conditions of a given
patient (De las Huertas, 2005, p. 22).
However, the professional negligence of the doctor
or the health institutions can be evidenced not only in a lack
of technical knowledge but also, for example, in the non-
performance of medical services or the late performance of
the same, the latter cases, unfortunately, being quite frequent
in the Colombian experience. In that order, by way of
explanation, but not exhaustive, medical fault can occur due
to the non-provision of the service, having the obligation to do
so, due to the late provision of the same, or due to a defective
diagnosis or treatment (De las Huertas, 2005, p. 24). The
above, considering that, in most cases, if not almost all, the
obligations of doctors are of means and not of result, a matter
that will be dealt with later.
Now, within the particularities of fault as a basis
or attribution factor, it is important to mention that it can
be generic or specific. The former occurs when the agent
disregards a generic duty that is mandatory for all persons, and
the latter when a particular or specific duty of a certain trade
or profession is disregarded (Guido, 2015, pp. 100-105). Well,
in the case of medical negligence, the specific fault is quite
relevant, if there are many guidelines and precepts applicable
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to this profession, including international conventions, laws,
decrees, resolutions, guidelines, principles, codes of ethics, etc.
In this regard, there is the international Convention on Human
Rights and Biomedicine - the Oviedo Convention - which, in its
article 4, enshrines the obligations of professionals, indicating
that all medical interventions must comply with the applicable
standards of conduct and regulations. In turn, Article 2
recognises the human being as a subject of prevailing interest
vis-à-vis society and science, and article 3 determines that all
persons shall have equal access to the benefits of health care
(Council of Europe, 1999).
As far as the Colombian legal system is concerned, it is
essential to refer to Article 26 of Law 1164 of 2007, which, in
paragraphs 1 and 5, establishes that health professionals must
act in a respectful, ethical and competent manner, seeking
the greatest benefit for users. In addition, professionals must
respect the limits of the Codes of Ethics, which are issued
by the Ministry of Health and Social Protection (Trujillo and
Patiño, 2019, pp. 21-36; Gómez, 2020)
2
. Additionally, there are
2
At this point it is important to make a caveat, at the time of writing, the
world is facing one of the most important problems in public health,
the SARS-COV 2 virus that leads to the COVID 19 pathology, which has
generated high levels of hospital occupancy, So much so that the National
Government, employing Legislative Decree 538 of 2020, granted the
territorial authorities the possibility of taking control of the supply and
availability of intermediate and intensive care beds in the IPS, intending
to maintain an efficient administration of these resources. In addition, the
Ministry of Health and Social Protection issued a document on
General
recommendations for ethical decision-making in health services during the
COVID-19 pandemic
. As we can see, this series of events has had the
effect of changing the models of care, as long as health care systems have
traditionally focused on patient-by-patient care, but this situation has
proposed - in an obligatory manner - a new paradigm where it is essential
to change the perspective of individual pathology for epidemiological
systems so that it is possible to respond to the health needs of the so-called
“new normality”. Consequently, the prevalence of the individual over
societies, a precept proclaimed by the Oviedo Convention, is a principle
that under current conditions is not being comprehensively protected.
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also other applicable regulatory bodies, such as Law 23 of 1981,
the Single Decree 780 of 2016, and other administrative acts
issued by the National Government.
Up to this point, we have already referred to
lex artis
based on the doctrine and applicable rules. Thus, to understand
what has been explained in greater depth, we will now refer to
case law, to identify how this concept is constructed in the courts.
First, we will review the case-law of the Civil Chamber
of the Supreme Court of Justice, which, in a judgment of 12
January 2018 (C. S. J., Civil Chamber, SC 003-2018, 2018),
studied a case in which the medical fault of a health service
provider was disputed, due to an error of assessment. The facts
of the case were that an entity had misdiagnosed the plaintiff
since she initially went to the health centre with a headache,
which was the result of an anxiety attack, for which the
treating physician ordered some painkillers and anxiolytics.
The following day, with the same symptoms, the patient went
to the same health centre again, claiming that the pain was
very severe, and on this second occasion, the diagnosis and
treatment given were reiterated. After 8 days, the patient went
to another health centre in a state of unconsciousness, where an
examination revealed a sub-acute infarction in a cerebral artery,
which resulted in a thrombosis that affected the mobility of one
arm, the loss of vision in one eye and a neurological disability.
In this case, the judge constructed the
lex artis ad hoc
based on
the principles applicable to the social security health
system, which are found in article 3 of law 1438 of 2011. In
addition, he referred to the Hippocratic oath, from which he
deduced the obligation of professional due diligence and the
application of the principles that make up medical ethics,
concerning technical and ethical aspects. Finally, in the study of
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the circumstances of time, manner, and place, the judge found
that the first diagnosis should be considered a diligent act, since,
according to the management guide for those symptoms, it
was not possible to foresee or infer that the plaintiff’s ailments
would have the consequences.
It is important to make a reservation in this case, as
Judge Ariel Salazar saved his vote to clarify that the
lex artis
ad hoc
was not correctly delimited in the motivation of the
judgement, provided that a more demanding level of diligence
should be inferred from the guidelines for the management of
the ailment. But not only that, and this is the interesting point
of the question, the Magistrate affirmed that the indifference of
the doctors to the pain and suffering of the patient disregarded
the principle of benevolence that characterises the medical
profession, so that the actions of the professionals should be
considered negligent, provided that the pain of the patient
was an alarm signal, from which the need for a more rigorous
examination and diagnosis could be inferred. This is a postulate
that, in the opinion of this writer, dignifies the position of the
individual concerning health systems, but also incorporates
ethical principles that must be respected by doctors, which not
only obey the scientific nature of the profession, but also the
humanity that it requires.
Concerning the same matter, the Third Section of the
Council of State, in a judgment of 10 April 2019 (C. E., Third
Section, No. 40916, 2019), studied a case in which the liability
of a social entity of the State is analysed. The case consists of
an obstetric injury, which occurred when a patient underwent
a vaginal hysterectomy, but during the procedure, a perforation
was caused in the rectum, which generated an infection that
resulted in her death.
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For the case, the court determined that the
lex artis
was
the set of all the human, scientific and technical means available
to doctors, considering the development of medical science at the
time of the occurrence of the harmful events. Because of the above,
it was concluded that the health institution acted negligently by
making a hasty diagnosis that did not consider the necessary
means to determine the existence of the infection. Thus, the
treatment ordered for the postoperative period was insufficient
to meet the patient’s needs.
Thus, the judge carried out a study
of the
lex artis ad hoc
based solely on technical considerations.
In summary, considering all that has been explained,
the
lex artis
is made up of two major elements: i) the technique
applicable to the exercise of the medical profession, hence the
so-called
lex artis ad hoc
, and ii) the rules that regulate the health
sector and its professionals, whether these are ethical precepts,
international conventions, laws, decrees or resolutions.
However, this is a particular institution for cases of medical
liability, which, it is worth clarifying, does not prevent a legal or
technical vacuum from solving a specific case, since we cannot
forget that the traditional legal concepts, such as professional
negligence, good faith, the principle of trust, the position of
guarantor (Jakobs, 1998) and others, are also applicable and of
obligatory observance to determine medical malpractice.
Thus, up to this point, we have developed some
particularities that characterise medical liability, this
concerning the trial of liability, which applies to any of the
possible jurisdictions competent to resolve this type of
litigation in Colombia. However, it is important to clarify that
these singularities are not sufficient to understand the civil and
administrative experience on the matter, which is why, in the
following, we will deal with each of these separately.
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1.1. Medical liability
The first thing that is indispensable and necessary
to point out is that medical civil liability arises on a contract.
Nowadays, in the civil jurisdiction, it is not possible to study a
case of medical liability under a non-contractual fact, which has
a quite simple explanation and has to do with the compulsory
application of the health benefit plans (PBS), which are
covered by the insurers (EPS) and executed by the health care
institutions (IPS), the vast majority of which are private. So,
whether it is a contributory or subsidised scheme, it is sufficient
for a private entity to provide a service covered by an insurer
for a contractual relationship to be established between the
doctor, the IPS, and the patient.
On the other hand, it is also possible to assess the liability
of insurers, as these entities are responsible for authorising
procedures, examinations, transfers, and medicines for patients
who are covered by a voluntary or compulsory plan. Thus, a
delay in the processing of a certain service may be attributable
to contractual liability.
Now, the above does not prevent a person, outside the
coverage of their insurer, from deciding to contact a doctor for
a service, which is quite frequent in cases of cosmetic surgery
(liposuction, rhinoplasty, bichectomy, blepharoplasty, among
others) or dental treatment. However, the scenarios are covered
by private contracts, which, as far as the resolution of conflicts
is concerned, are heard before the civil jurisdiction.
However, one of the most important legal debates in
the field of medical civil liability has to do with the type of
contract that gives rise to these services (Hinestrosa, 2015, pp.
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232-234)
3
, which is not a minor matter, since the negotiating
figures allow the obligatory content of the parties to be deduced.
Recalling, contracts have essential, natural, and accidental
elements, where the first are those without which a certain type
of negotiation would not arise, the second are those inherent to
each contract and the last are those that the parties, under the
negotiation, stipulate. Thus, the nature of the contracts makes
it possible to determine the obligations to which each person,
creditor or debtor, is bound, without the need to refer to the
special provisions that the parties have agreed. In other words,
each type of contract,
per se,
has a consubstantial content,
which is understood to be agreed with the concretisation of
private autonomy.
That said, the doctrine has mainly proposed two
types of contracts for the provision of medical services: the
mandate and the leasing of immaterial services. This will
not be explained exhaustively, but the figure of the mandate
was proposed to the extent that, in theory, the patient gives
the doctor an assignment. However, if this were the case,
the current legislation establishes that the principal has the
possibility of issuing instructions to which the mandatary will
“strictly adhere”, which, to tell the truth, does not correspond
to the reality of this service. This is provided that the doctor is
the one who determines the treatment plan according to the
conditions of the diagnosis; but it is also not true that, by this,
the doctor has the possibility of acting “in the way that seems
most convenient to him” (Civil Code, 2005, art. 2159), as is also
indicated in the regulation of this type of contract (Jaramillo,
2019, pp. 203).
3 The contract, as a type of legal transaction, must be understood as a link
arising from the agreement of wills of two or more persons, the purpose
of which is the creation of an obligation or the creation, modification, or
extinction of a legal relationship.
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In addition, another criticism of the mandate contract
states that the doctor does not have the possibility of acting
on behalf of his client using representation, that is, a faculty
that, although it does not belong to the nature of this type
of business, is characteristic of it. In that order, the doctrine
finds that the contract for the leasing of immaterial services is
more appropriate for the provision of medical services, since it
does not involve acting on behalf of or representing another,
the main obligation of the debtor lies in the performance of a
service in favour, solely, of the creditor (Jaramillo, 2019, pp.
204-209)
4
.
However, it has also been said that the leasing of
immaterial services is not the right type of contract either,
because it requires the intelligence of the service provider to
predominate over the labour force, which is not at all suited
to the activity of doctors, in which it is possible to use any of
these resources for the performance of their work. Thus, it is
not possible to affirm that all the rules of this type of contract
can cover the entire relationship that exists between the doctor
and his patient, which is why it has been proposed that the
contractual link of medical services is atypical (Pizarro, 2014,
pp. 827-830), a position that has been adopted by the Supreme
Court of Justice (C. S. J., Civil Chamber, SC 5507-2001, 2001).
Consequently, the fact that there is no legal regime
that makes it possible to design a contract for medical services,
either as a mandate or a lease, obliges the doctrine to consider
that these must be executed within the framework of an atypical
scenario, which implies recognising the complexity of the
medical dynamic if this is characterised by its changing
lex artis
4 It cannot be overlooked that for some exceptional cases, the construction
contract has also been proposed for medical services, this in cases of
aesthetic surgical procedures.
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and the dispersed applicable regulation. Indeed, the obligatory
content of the medical contract requires interpretation in the
light of the prevailing uses, practices, and knowledge for this
profession (C. S. J., Civil Chamber, SC 5507-2001, 2001, p.
830), it is also necessary to bear in mind that, in some cases,
consumer relations are configured (C. S. J., Civil Chamber, SC
2804-2019, 2019)
5
where the users of the health system deserve
to be protected as weak parties to the contract (Giraldo, 2013,
pp. 216-219).
Based on the above, the question then remains: What
is the type of obligation that the professional contracts on the
medical services contract? Much can be said about this since
legal dogmatics has many criteria for classifying obligations
(Hinestrosa, 2015)
6
, but about the contractual liability of the
doctor, the discussion can be limited to the obligations of means
and results.
The liability of a debtor is drastically altered when we
speak of obligations of means or results. To explain the above,
it is necessary to consider that obligations of means consist of
the provision of service using all the standards of expertise,
diligence, and prudence necessary for the achievement of an
end, the latter understood as the main interest of the obligee.
However, even though the latter goes into business with a
specific objective, the fact that the obligor is only obliged to
the performance of its possible means implies that the obligor
cannot allege non-performance just because its interest has not
5 The jurisprudence of the Court has recognised the doctor-patient
relationship as a consumer relationship, especially about the suitability
of the service provided, without this implying the application of a strict
liability regime.
6 Among the most common classifications are natural obligations, obligations
to give, to do, not to do, of guarantee, means and results, security, joint,
and several, conditional, optional, alternative, etc.
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been realised. In this case, then, the obligor’s liability is only
possible when its actions do not correspond to the expertise,
diligence, and prudence required for the provision of certain
services (Hinestrosa, 2015, pp. 237-241).
In contrast, obligations of result imply for the obligor
the achievement of an end, which must satisfy the interest of
the obligee. This is the case, for example, of the obligations to
give, where the effective delivery and tradition of an object
are indispensable, a matter that in effect cannot be understood
as the deployment of a set of judicious and well-intentioned
actions that intend, but do not ensure, the achievement of an
objective, but rather that it is necessary to achieve the result
described in the negotiation agreement (Bonivento, 2017)
7
. Thus, in this type of obligations, the conduct of the obligor
is not studied to qualify the non-performance, it is sufficient
to establish whether the obligor complied with the promised
result of the obligation, so that the expertise, diligence, and care
are of no use when it is intended to exempt the obligor from
liability (Bonivento, 2017).
Now, in contracts for medical services, professionals
are not obliged to achieve a result it would be wrong for the
doctor to ensure the cure of pathology when the truth is that
this does not only depend on the capacities that he possesses.
On the other hand, the regime applicable to the contractual
liability of the doctor is determined by the obligations of
means, according to which the doctor must use his skills
and knowledge to achieve an end, which, in his field, is the
prevention, diagnosis, and treatment of diseases.
7 The following contracts with performance obligations can be mentioned:
purchase and sale, lease, work contract, mutual agreement, bailment,
commodatum, exchange, deposit, etc.
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In this order, and as the Supreme Court of Justice has
understood, the performance of the doctor within a service
contract is satisfied with the execution of his work carefully
and diligently, but in addition to this, it is also necessary to
take into account the application of the
lex artis
, this being
understood, I repeat, as the body of knowledge that medical
science has for a given time and case (C. S. J., Civil Chamber,
SC 7110-2017, 2017).
This issue of obligations of means in medical service
contracts has been so widely accepted that Article 104 of
Law 1438 (2011) states that the relationship of
“
health care
generates an obligation of means
”
. So, the problem remains to
determine in which events the physician’s obligation is one of
the results. For this, the solution is quite simple and following
the position of the Court (C. S. J., Civil Chamber, SC 7110-2017,
2017), we can affirm that the health professional will be obliged
to the achievement of a result when so stipulated in the contract
(M’Causland, 2019, p. 583), which can be seen in some cases of
aesthetic surgeries.
Additionally, in a recent judgment of 7 December 2020
(C. S. J., Civil Chamber, SC 4786-2020, 2020), citing a judgment
of 5 November 2013 (C. S. J., Civil Chamber, SC 2005-00025,
2013), the Court (2013) indicated that the obligations of results
could also be configured in those cases in which
“
the margin
of uncertainty of the medical activity is reduced because the
variables that can negatively influence recovery are under
the control of the professionals
”
(s. p.)
. In
that order, when
medical treatment or procedure has the possibility of directly
influencing a person’s health, with such a level of assertiveness
that recovery can be assured, the health professional’s obligation
will no longer be one of means but one of the results. This is
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also the case for damages arising from the omission or delay
in the provision of medicine, examination, laboratory analysis,
immobilisation of a limb, or fitting of an orthopaedic appliance.
Thus, the general rule is that the obligation contracted
by the doctor is one of means, as established by regulation and
jurisprudence, in which case diligence and care, based on the
lex artis
, serve to exempt him from liability. Exceptionally,
however, the obligations will be of result, in which case the
exemption from liability is only found in the effective fulfilment
of what was promised or the existence of force majeure.
Having said the above, up to this point, we have
evacuated those particularities that characterise the medical
civil liability trial in Colombia, which can easily coincide with
the experience of other latitudes. Now, after the trial, the most
important aspect of liability is the evidentiary regime, after all,
it is through this that each of the categories that give rise to the
indemnity obligation is fed. Thus, it is important to determine
the allocation of the burden of proof, in other words, who, how,
and why must prove. This is, in short, a matter of the first order
for any judicious jurist.
As far as the evidentiary regime in medical liability
is concerned, the most important developments have been
in the category of fault, which is hardly consistent with what
has been explained up to this point, since the general rule is
that the physician’s obligation is one of means, which requires
qualifying his conduct to determine whether he has incurred
non-compliance and, therefore, liability.
To begin with, one of the main theories on the allocation
of the burden of proof in these cases is found in Article 1604 of
the Civil Code (2005), which recites that “proof of diligence or
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care is incumbent on the one who should have used it; proof of
an act of God is incumbent on the one who alleges it”. By this
provision, it is said that the physician, as the party obliged to
exercise diligence and care, is the contractual party responsible
for proving the absence of fault, which in practice has the effect
of a presumption in favour of the patient. Consequently, if the
latter proves, within the trial, the existence of an injury and its
causal relationship with the health care service, the presumption
operates, which results in a condemnatory sentence, when the
doctor does not demonstrate that his actions correspond to the
lex artis
.
In the previous position, there are doctrinaires, such
as Professor
Fernando Hinestrosa
, who indicate that they agree.
However, the way to reach this conclusion is different, since,
according to article 1757 of the Civil Code, every creditor must
prove the obligation that it intends to enforce and its breach,
so it would be understood that the general regime applicable
to the obligations of means is one of proven and not presumed
fault. But in the case of health care contracts, given the ease
with which the doctor has access to the means of conviction, he
or she is the one called upon to bear the burden of proof, so it
would be worth applying the presumption of fault (Hinestrosa,
2015, p. 586).
On the other hand, and considering the rules of the
mandate contract, let us remember that this type has been
proposed for medical services, it has been said that under the
last paragraph of article 2184 of the Civil Code, the principal
will be responsible for proving the agent’s fault, which means
that the patient must prove that the doctor has been negligent
(Tamayo, 2015, p. 1090).
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From what has been mentioned so far, it is important to
bear in mind that within the legal world it is considered that a
presumption of fault is a prerogative that facilitates the plaintiff’s
action within the process and that the opposite is a neutral or
impartial scenario, but the truth is that a proven fault regime
is nothing other than a presumption of diligence in favour of
the defendant (M’Causland, 2019, pp. 579-652). However, in
this writer’s opinion, one or the other of the above-mentioned
presumptions is a matter of argumentative order that reaches
into legal policy. The position adopted by the Court, as far as
medical contracts are concerned, is a proven fault regime (C. S.
J., Civil Chamber, SC 2804-2019, 2019), which is based on the
protection of medical activity as a socially useful profession, a
matter that will be discussed in the following sections.
Despite the above, it cannot be left aside that, currently,
for any kind of process there is the theory of the dynamic burden
of proof, which came about with the implementation of Article
167 of the General Code of Procedure. This rule determines
that the judge, at the request of any of the parties or ex officio,
may order the reversal of the burden of proof, a matter that
only depends on the conditions of the specific case, where
it will be analysed who is in the best position to provide the
means of conviction. Thus, if the doctor is in a better position to
prove, the patient may request a reversal of the burden of proof
concerning one or more of the facts that are not established in
the litigation. This is a tool that is not only applicable to a fault
but to any of the elements of the trial.
In summary, in this section, we address the experience
of medical civil liability in Colombia, for which we explain the
contractual typology, the type of obligation contracted by the
health professional, and the evidentiary regime applicable to
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these cases, as the most important points for this matter. We
will then go on to explain the medical liability of the State in
Administrative Law.
1.2. Medical liability of the State
In comparison with civil liability, the liability of the
state brings to the academic and judicial world more demanding
debates that deserve a high argumentative content, not only
because one of the subjects involved in the litigation is the
Colombian state, but also because of the absence of norms in
this respect, a matter that does not allow controversies to be
avoided with the reasoning of syllogism and interpretation
8
. In
effect, the non-contractual liability of the state is based solely
on Article 90 of the Political Constitution, a norm that has
served for the development of all the categories of the trial.
Thus, the medical liability of the State develops in a
different dynamic to that of civil law, so much so that all cases
are analysed in the extra-contractual scenario, in addition
to the fact that the health care service must be provided by a
State Social Enterprise (ESE), which may be a public Health
Care Provider Institution (IPS), that is, a hospital or a Health
Services Provider Unit (UPSS).
To explain why the medical liability of the State
always occurs in the non-contractual sphere, it is necessary to
understand that in Colombia health care is part of the State’s
provision of services, which is a service that must be guaranteed
according to the infrastructure and budget possibilities of
the public administration. This is following Article 49 of the
8 Exceptionally, within the liability of the State, there are some cases with
their own rules, as is the case, in the non-contractual sphere, of liability for
judicial error, defective functioning of the administration of justice, and
unjustified deprivation of liberty. In turn, in the contractual sphere, all the
rules regulate all the types of contracts that the state can and must enter into.
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Political Constitution (1991), which states that “Health care and
environmental sanitation are public services provided by the
State. All persons are guaranteed access to health promotion,
protection, and recovery services”.
Moreover, when an ESE or UPSS provides a health
service to a person, it does not do so by a contractual relationship,
but through a regulated activity of a welfare nature guaranteed
by the State. Consequently, the patient is understood as a user
of the health system, who does not previously have a business
relationship with the service provider (C. E., Third Section,
No. 36738, 2017). Now, it has long been known that non-
contractual liability arises in the context of occasional events,
which are characterised by being eventual or contingent, but in
these cases, the situation is quite different, since the provision
of health services by the State is framed within the scope of
public policies, which are governed by the principles of legality
and administrative planning.
Now, the trial of non-contractual liability of the State
is constituted with the same three presuppositions of civil
liability, namely: damage, imputation, and basis or attribution
factor. However, it is pertinent to clarify that the legal
nomenclatures change. In other words, the essence of State
liability has the same logic as civil liability, i.e., the emergence
of a compensatory obligation based on the three assumptions:
damage, imputation, and grounds, but within these three
categories there are different terminologies which, briefly, we
will explain below.
There is not much to say about damage, because the
differences only lie in the issue of the typologies of non-
pecuniary damage, which is not relevant to what we are going
to deal with, so I recommend its study in a separate text.
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As far as imputation is concerned, the matter is a
little more complex. Let us remember that it can be factual
or normative, where the former is the causal relationship that
exists between the agent’s conduct and the damage suffered by
the victim, and the latter consists of attributing damage based on
legal duty. In civil matters, the normative imputation can occur,
for example, in the regime of liability for the acts of others, in
these cases the liable party has not deployed any action, but
under a legal duty, the damage is attributable to him. The same
is true for cases of the act of things, where guardianship can be
a criterion of imputation. However, the figures are proper to
civil law they are enshrined in the code.
However, the above does not operate in the same way
in the administrative jurisdiction, since the advent of normative
imputation occurred on the theory of objective imputation in
criminal law (C. E., Third Section, No. 21928, 2012). Thus,
the legal duties for the attribution of damage no longer rest on
criteria such as the actions of others or the protection of things
but are developed based on the permitted risk, the principle
of trust, the position of the guarantor, the action at one’s own
risk, the prohibition of return and the purpose of protection
of the norm, all these tools with criteria and conditions of
jurisprudential construction (Gil, 2015, pp 75-130).
Concerning the bases or attribution factors, there
are three in the liability of the State, the failure of service,
exceptional risk, and special damage, the first two brought from
the general theory of liability and the last one a figure specific
to Administrative Law (Rodríguez, 2017, pp. 321-332). Let us
see, failure in service is nothing other than the fault, but its
connotation responds to the disregard of the legal obligations
required by the exercise of the administrative function. Let
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us remember that the actions of the authorities are regulated
and subject to the principle of legality, so that the failure is not
evidenced by the existence of an open archetype, such as the
good father of a family, but is seen in the light of the principles
and laws that determine how the public administration should
act. In that order, the failure can be due to the non-provision of
public service, defective provision of the same, or late provision
(C. E., Third Section, No. 4910, 1986; C. E., Third Section, No.
53953, 2020).
On the other hand, the exceptional risk is a basis that
comes from the objective theory of liability, where the lawful
increase of the normal levels of risk allows the attribution of
damage without qualifying the conduct of the State so that
the applicability of the compensation obligation only depends
on the proof of the damage and the factual or normative
imputation. Thus, the construction of work or the provision of
a service using instruments or activities that place individuals
in a situation of exceptional risk is susceptible to liability under
an objective regime (C. E., Third Section, No. 4655, 1989; C. E.,
Third Section, No. 49426, 2020).
As far as special damage is concerned, this is a specific
type of state liability and, like the exceptional risk, it occurs
in the context of lawful action. Now, in this case, the basis is
the principle of equality before public burdens, which aims to
maintain the demands of the state equitably among its citizens,
so that no one must bear a particular imposition. Consequently,
when the state imposes an exceptional burden on a citizen
through a lawful act, the latter has the possibility of claiming
compensation for the damage suffered. An example of this
occurs when a private individual is subjected to a security
measure in criminal proceedings and then acquitted, without
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the judge or the prosecutor’s office has failed to act. In this case,
the lawful action of the administration results in special damage
that does not correspond to the public burdens that every
citizen must tolerate (C. E., Third Section, No. 1482, 1976; C.
E., Third Section, No. 55901, 2020).
Having said the above, within administrative law, the
general liability regime applicable to health care services is
subjective, i.e., through the basis of service failure. In turn, but
exceptionally, strict liability is also applicable, based on the
exceptional risk factor.
Regarding subjective medical liability, we should
mention that, as in the civil jurisdiction, the main debate has
arisen around the category of failure of service. However,
the discussion is not about what is understood as negligence
or not in these events, for which the traditional methodology
of the Council of State has not changed, but about the
applicable evidentiary regime. The above, is worth noting,
with a particularity: let us remember that in civil matters some
normative provisions allow us to conclude the allocation of the
burden of proof, but in the case of the non-contractual liability
of the State this is not the case.
For this reason, at first, the medical liability of the
State developed in a regime of proven failure, which assigned
the burden of proof to whoever sought to enforce the effect
of a rule, so that, if a private individual requested the liability
of the State, the latter had to prove the existence of damage,
imputation, and failure of service. In contrast, as it was in its
interest, the state had to prove the grounds for exclusion of
liability (Gil, 2015, p. 636).
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After this, the Council of State, through its jurisprudence,
determined that the evidentiary regime applicable to medical
liability consisted of presumed failure if the administration has
to demonstrate that it acted diligently, insofar as its activities are
governed by the principle of legality. Thus, it was only necessary
for the individual to prove the damage and the imputation, and
it was the State’s duty to prove the non-existence of failure or
any of the grounds for exclusion of liability (C. E, Third Section,
No. 5902 1990).
In addition, the presumed failure regime also rested on
the idea that the administration, in these cases, as the provider
of health care services, is in a better position to prove, since its
knowledge of medical science allows it to access the means of
conviction in a simpler way (C. E., Third Section, No. 6897, 1992).
However, the position was debated by the Council of
State itself, since it was said that the theory of presumed fault
assumed that in all cases one of the parties was in a better
position to prove, a matter that could not be applied as a rule
because it lacked empirical verification. Thus, it was concluded
that the most accurate way to determine who was in a better
position to prove was through a dynamic theory, which is based
on the principle of fairness for the allocation of the burden
of proof so that this depends on the study of each case (C. E.,
Third Section, No. 11878, 2000).
Now, the main criticism that the dynamic theory of
evidence received is that advisors and judges did not have the
legal power to modify the burden of proof within the process,
a point that was avoided with the issuance of the General Code
of Procedure and its figure of the dynamic burden of proof,
which is applicable in administrative proceedings under article
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211 of the Code of Administrative Procedure and Contentious
Administrative Proceedings.
On the other hand, regarding objective medical liability,
this is a regime that has been developed in an exceptional
manner, which only proceeds in certain cases, which are
enshrined in case law. Thus, according to the Council of State,
the health care service gives rise to the objective regime in the
cases of intrahospital or nosocomial infections, application
of vaccines, supply of medicines, and when new therapeutic
methods with unknown consequences are used (C.E., Third
Section, No. 20878, 2011; C. E., Third Section, No. 21515, 2012;
C. E., Third Section, No. 22424, 2012). In the following, we will
explain each of these scenarios.
1.2.1. Nosocomial infections
Concerning the first scenario, nosocomial infections,
it is necessary to explain that these are those acquired during
the performance of in-hospital medical treatment, which may
occur in the performance of surgery, when a patient is treated
in the emergency room or when he/she requires hospitalisation
and observation in intermediate or intensive care. However, the
particularity of this type of infection is that they do not arise
from the pathology for which the user comes to the health care
service but is transmitted during the provision of the service.
An example of this was a case study by the Third Section of the
Council of State, in which a pregnant woman was admitted to a
hospital to give birth, however, after the procedure, the patient
presented symptoms of an infection acquired during childbirth,
which caused a multisystemic organ failure and, therefore,
death (C. E., Third Section, No. 26124, 2012).
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It is worth saying that there are two positions on this
point, the first of which posits that nosocomial infections are
a risk inherent to the medical activity of healthcare systems
so that informed consent makes it possible to transfer the
realisation of the risk to the patient’s responsibility. This is the
theory held by the Civil Chamber of the Supreme Court (C. S.
J., Civil Chamber, SC 2202-2019, 2019). Thus, liability for this
type of disease is only possible when it is proven that the IPS
or the doctor acted negligently in the implementation of the
epidemiological protocols, the latter understood as the technical
guidelines aimed at eliminating, controlling, or mitigating the
effects of infectious diseases.
In contrast, the Third Section of the Council of State
has determined that nosocomial infections imply a risk that
must be borne by the state and that informed consent does
not allow this to be transferred to the patient. This is if there
are reasons for distributive justice and equity through which
the public entities providing health services are called upon to
assume the damages that occur on an intra-hospital infection.
It has also been mentioned that in these cases consent cannot
be considered perfect, since it is impossible to inform the user
about the totality of the possible infections that he or she may
contract and their consequences, which is indispensable when
it is intended to transfer the risks of the medical act to the
patient (C. E., Third Section, No. 396122, 2017).
Thus, the liability regime applicable to nosocomial
infections is objective, which is based on the title of exceptional
risk
9
, making it impossible for public entities to exempt
9 Despite the above, a question arises based on the context in which these
lines are written. Will the damages caused by COVID 19 nosocomial
infections be attributable to the state based on the strict liability regime?
Concerning this question, we will only make a small comment. Let us
recall that in the strict liability regime due diligence and fortuitous event
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their liability by proving due diligence in the application of
epidemiological protocols, as could be done in a subjective
regime - as is the case in the liability regime of the Civil Chamber
of the Supreme Court of Justice (C. S. J., Civil Chamber, SC
2202-2019, 2019).
1.2.2. Application of vaccines
Within public health policies, most countries have
implemented immunisation programmes for the population
against certain infectious diseases, for which vaccination
plans have been essential. Today, the vaccination schedule in
Colombia is oriented toward all children under 6 years of age,
which has around 22 vaccines for 26 types of diseases. It is also
important to note that there are plans for adult immunisation,
but with lower coverage and only for 7 diseases (Ministry of
Health and Social Protection, 2020).
However, even though the objective of vaccination is
to immunise people against certain diseases, the application of
these medicines can, in some cases, have negative side effects
on people’s health. For this, the Third Section of the Council
of State has determined that the applicable liability regime is
objective, this based on the title of exceptional risk, since a
lawful act of the State in the implementation of this type of
public policy has the effect of an unusual alteration of the risk
for certain people, who should not bear the negative effects of
health programmes (C. E., Third Section, No. 41390, 2019).
are not exemptions from liability, but force majeure and the act of a
third party are. Thus, it will be of vital importance to determine to what
extent the conditions of the Colombian Health System may constitute a
force majeure scenario, where high levels of care and scarce resources
are fundamental to determine whether or not the State could have acted
otherwise. At the same time, it should be considered whether informed
consent, concerning COVID 19, could be a tool for risk transfer, as patients
were aware of the risks and consequences of attending the health system
in times of pandemic.
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By way of example, we can mention a case in which the
responsibility of the State for the application of a polio vaccine
was studied. The facts were that a mother took her two-and-a-
half-month-old daughter to a health centre for the application
of the vaccine, which happened normally, but days later the
child presented health complications and, in a new visit to the
health service, she was diagnosed with a post-vaccination polio
infection, a pathology that caused her permanent quadriplegia
(C. E., Third Section, No. 41390, 2019).
The reason for establishing strict liability in these
cases is that the State, in its immunisation schemes and plans,
implicitly assumes the possible danger and adverse reactions
of vaccines in different types of organisms. Thus, due care
in the transport, conservation, cold chain, and application of
vaccines does not serve to exempt itself from liability as an act
of diligence, nor does the fortuitous event, understood as the
unpredictability of the effects of these medicines. Thus, the
objective regime in these cases will only allow force majeure
and the act of a third party to serve as exonerating factors in the
liability trial (Cely, 2020).
1.2.3. Supply of medicines
There is no need to comment on this case this case works
the same as the one explained in the application of vaccines (C.
E., Third Section, No. 40562, 2017). Vaccines are medicines,
and this regime is foreseen for cases in which damage can be
caused by the supply of analgesics, anxiolytics, antipyretics,
anti-inflammatory, anti-gout, anti-allergic, anticonvulsants,
antibiotics, antibacterials, anticoagulants, antihypertensives,
antirheumatics, antacids, diuretics, disinfectants, among others
(World Health Organisation, 2007).
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However, it is important to bear in mind that when
we talk about the supply of medicines under the strict liability
regime, we are only referring to the unforeseeable side effects
that these can generate in different organisms. Liability for the
failure to supply medicines or a mistake in prescribing them are
assumptions that must be studied under the title of failure of
service within the subjective regime (C. E., Third Section, No.
35116, 2016; C. E., Third Section, No. 36933, 2016).
1.2.4. New therapeutic methods with unknown
consequences
Finally, the strict liability of the state for the application
of therapeutic methods with unknown consequences is based
on the execution of the medical activity in a risky manner,
with the aggravating factor that the possible effects of a certain
treatment are not known, which does not allow the patient to
give informed consent, as this should consist of an explanation
of the procedure to be carried out with its possible benefits and
negative effects (C. E., Third Section, No. 17733, 2009). Thus,
the basis used in these cases is the exceptional risk, however, it
is important to mention that the jurisprudence on this point is
quite scarce.
With the above, we conclude the section on state medical
liability. In the following, we will make some brief reflections
on what has been explained in civil and state medical liability,
considering the particularities of each of these regimes.
2. SOME REFLECTIONS ON CIVIL AND STATE MEDICAL
LIABILITY: A CRITIQUE OF THE IRRELEVANCE OF
INFORMED CONSENT IN THE LIABILITY SUIT
Up to this point we have dealt with many issues, this
journal article began by analysing, in a comparative manner,
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the civil and administrative experience of medical liability,
considering the doctrine and jurisprudence of the Civil
Chamber of the Supreme Court of Justice and the Third Section
of the Council of State. However, I cannot leave these lines
without first making a quite specific criticism of what has to do
with medical liability and informed consent.
First, the first thing I should point out is that my
criticism consists of the irrelevance of informed consent in
the liability trial, given that, in jurisprudence - especially in
civil experience - no practical application of this figure can be
found. In other words, judges do not attribute any effect to the
disregard of informed consent by health professionals, even
though academia and jurisprudence consider that this figure
acts as a prerogative of self-determination in favour of the
patient, which is linked to the fundamental rights of freedom
and the free development of personality. At the end of the
day, informed consent is the tool that allows the patient not to
be a means of medical practice, but an end, which serves to
recognise the subjects as free persons capable of deciding on
their health and personal integrity.
Thus, the structure of this section will be developed as
follows: first, the figure of informed consent and its importance
for the practice of medicine will be explained, followed by the
experience of the Supreme Court of Justice and the Council
of State, and finally, we will explain the error made by the
jurisprudence in not granting effects to the lack of informed
consent in the trial of liability.
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2.1. Informed consent and its relevance to the practice of
medicine
Informed consent is the part of the medical act in which
the health professional informs the patient about the procedure
to be performed so that the patient can give or withhold his
or her consent. So, while it is true that the professional is the
one who knows the medical science, it is only the patient who
can decide about his or her health and personal integrity, this is
what is known as self-determination.
Now, to inform the patient about the applicable medical
procedure, it is not only required that the professional specifies
what it consists of, but it is also necessary to fully, clearly,
and sufficiently explain the possible risks and benefits of the
therapeutic or surgical treatment that will be carried out, also
considering the material or logistical shortcomings of the IPS,
when applicable. The problematic nature of this issue is such
that it is practically related to all medical acts since if there is no
clear communication between the professional and the patient,
it can generate a wrong consent or, for example, suppose that
the doctor makes a mistake in the diagnosis and informs about a
treatment that is not suitable, in this case, the patient will issue
an authorisation that does not correspond to the reality of his/
her health condition (García, 2018, p. 125).
Indeed, informed consent is a vitally important issue,
provided that the patient has a right to be informed and to decide
about his or her body and personal integrity. Indeed, the Lisbon
Declaration on the Rights of the Patient, adopted by the World
Medical Assembly, states in paragraph 3, subparagraph “a” that:
“The patient has the right to self-determination and to make
decisions freely concerning himself/herself. The physician shall
inform the patient of the consequences of his or her decision”.
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Additionally, paragraph “b” of the same numeral, it mentions
that: “The mentally competent adult patient has the right to give
or withhold consent to any examination, diagnosis or therapy.
The patient has the right to the information necessary to make
his or her decisions” (World Medical Assembly, 1981).
In turn, the Oviedo Convention recognises consent
as a Human Right, in the following terms: “An intervention
in the field of health may only be carried out after the person
concerned has given his or her free and informed consent”
(Council of Europe, 1999).
As far as the Colombian legal system is concerned,
informed consent is not recognised as a right of the patient, but
as a duty of the physician, who must request it for any kind of
procedure. This is found in Article 15 of Law 23 (1981), which
states that:
The physician shall not expose his or her patient to
unjustified risks. He shall seek the patient’s consent
to medical and surgical treatment that he considers
necessary, and which may affect him physically or
psychologically, except in cases where this is not
possible, and shall explain the consequences of such
treatment to the patient or those responsible for him in
advance. (art. 15)
However, Article 8 of the law indicates that the patient
is free to dispense with the services of the physician. However,
it is important to clarify that in cases of urgency, informed
consent is dispensable for the practice of a medical act, such
as when a person suffers an accident, becomes unconscious,
and requires medical attention, in these emergency cases the
duty of care allows the physician to act without informing the
patient or his relatives.
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On this point, in a judgement of 12 September 1994 (C.
C., T 401/94, 1994), the Constitutional Court has indicated that
informed consent is a fundamental tool for the exercise of the
right of every patient to refuse the application of the treatment
on his or her body. In addition, it was mentioned that, in the
medical relationship, both the patient and the professional
have the possibility of withdrawing and, if this is not done, the
doctor must inform the patient of all the implications of the
treatment. Finally, the Court recalls that there are three cases,
for reasons of vital urgency, where consent is not necessary:
i) when the patient’s mental state is not normal, ii) when the
patient is in a state of unconsciousness, and iii) when the
patient is a minor.
Despite the above, it is important to point out that all
the above-mentioned provisions, both at the international and
national level, have not been sufficient to ensure that in all
cases health professionals fully respect the right of patients to
be informed and, on that basis, to give or withhold consent. At
this point, it is essential to mention a very common case, which
has to do with the practice of obstetrics and gynaecology,
where violent practices by medical personnel are recurrent,
including the lack of information to women about the different
procedures performed during childbirth, which have negative
consequences on sexual and reproductive life (Pozzio, 2016, p.
101-106). Such as an example, the carrying out of unnecessary
cessations (DANE, 2018)
10
, repetitive vaginal examinations
without justification, frequent use of oxytocin to accelerate
labour, and, the most serious of all, the practice of episiotomy
10
The performance of unnecessary caesarean sections is one of the most
recurrent violent practices, especially when the health professional has
not obtained consent for it. The World Health Organisation has indicated
that C-sections should not exceed 15% of births, but in Colombia, this
figure is as high as 45%.
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without consent, which consists of a vaginal incision to widen
the exit canal of the foetus (Barbosa and Modena, 2018, p. 2).
In summary, informed consent is, more than a duty of
the physician, a fundamental right of the patient to be informed
and to give or withhold consent to the procedure proposed by
the physician, which must be explained clearly and considering
its risks and benefits, with the aim that the patient’s decision is
free of force or error.
2.2. Jurisprudence of the Supreme Court of Justice and the
Council of State: the irrelevance of informed consent
Having said this, we will mention some of the
jurisprudential references that have been made to the issue of
informed consent, from the perspective of the Supreme Court
of Justice and the Council of State. Thus, we will look at each of
these points in separate items.
2.2.1. Civil Chamber of the Supreme Court of Justice
The first case decided on 26 July 2019, arises from the
practice of “refractive surgery with laser excision to correct high
myopia and reduce dependence on contact lenses and glasses”
(C. S. J., Civil Chamber, SC 2804-2019, 2019, s. p.), this procedure
was performed on each of the patient’s eyes two days apart.
However, the result of the surgery was not the desired
one and the patient lost a percentage of her vision, which,
according to the defendant’s doctor, was an inherent risk of
the procedure. Now, one of the main arguments of the plaintiff
to prove medical negligence was the lack of information
necessary to issue consent. It was proven in the process that
the professional had not informed the patient adequately so
the patient was not fully aware of all the risks involved in the
practice of the procedure.
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Despite the above, the judgement states that the lack of
informed consent has nothing to do with the act of negligence
that must be proven for an obligation to pay compensation to
arise. Thus, the defendant’s doctor proved in the proceedings
that he had carried out all the necessary procedures for the
proper performance of the surgery so that in no way could fault
be asserted as a basis for the liability judgement. In summary,
the court mentioned that the claimed damages were not an
unavoidable consequence of the doctor’s failure to comply with
his duty to inform. Consequently, the doctor was acquitted.
On the other hand, in a ruling of 14 December 2018 (C.
S. J., Civil Chamber, SC 5641-2018, 2018), a patient underwent
a surgical procedure to have material removed that served her
to recover from an “anterior cervical arthrodesis”. However,
once she came out of the operation, the patient was in severe
pain, for which the anesthesiologist ordered an analgesic and
then proceeded to evaluate her, finding an oximetry problem,
for which reason a transfer for intubation was ordered. Once in
intensive care, the doctors noticed sudden oedema in the back
of the neck, and an attempt was made to remove the haematoma
by performing surgery, but while the procedure was being
carried out, the patient died, so the postoperative period for
the main surgery lasted no more than 80 minutes.
According to the evidence in the case, it was determined
that the doctors had not acted negligently, as what happened was
an inherent risk of the surgery. However, when the informed
consent was reviewed, it was found that there were several
inconsistencies in the information that the doctors provided to
the patient before the surgery. But as in the case, the judge did
not consider that such omission was susceptible to breach of
contract, so the defendant clinic was acquitted (C. S. J., Civil
Chamber, SC 5641-2018, 2018).
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Finally, in a judgment of 24 May 2017 (C. S. J., Civil
Chamber, SC 7110-2017, 2017), a patient required the practice
of a “laparoscopic cholecystectomy”, that is, a surgery through
which the gall bladder is removed. However, in the post-
operative period, the patient had abdominal pain that forced
the professionals to perform some additional tests, where it was
discovered that the first procedure performed had perforated
the small intestine, which generated a rather dangerous
infection.
In this case, again, the court found that the patient had
not been adequately informed about the risks of the procedure.
However, following the logic explained above, it was concluded
that the lack of consent had no bearing on the medical
practice so the risk was inherent to the procedure performed.
Furthermore, bordering on rudeness, the ruling mentioned
that the defendant’s professional was “connoted” so that his
capacity allowed him to expertly perform the laparoscopy,
which left aside the fact that he had not provided the necessary
information for the patient to decide about her health and
personal integrity. In other words, according to the Court’s
reasoning, the more reputable the doctor’s reputation, the
lesser the duty of information he has towards his patients (C. S.
J., Civil Chamber, SC 7110-2017, 2017). Thus, the defendant’s
liability is not proven.
Despite the above, in a recent judgment of 7 December
2020 (C. S. J., Civil Chamber, SC 4786-2020, 2020), the Court
analysed a case in which a woman underwent cosmetic surgery
for liposuction. However, after the intervention, the patient
suffered abdominal pain, pallor, and other abnormal conditions
that caused multi-systemic damage to her health and led to her
death. In this case, the plaintiff argued that the victim’s death
was the result of medical negligence.
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Thus, the particularity of this case lies in the fact
that the court found the means of proof to ensure that the
defendant’s doctor had undertaken to perform an obligation
to achieve a result. Not only that but in the
obiter dicta of
the
judgment, it is stated that a correct disclosure of the risks and
the respective consent of the patient to these risks mitigates the
doctor’s liability, even though the doctor has committed himself
to the achievement of a result. In addition, and coming to the
most important point, the Court affirmed, for the first time,
that in the absence of informed consent, medical personnel
must assume the consequences of their omission and diligence
cannot exempt them from liability (C. S. J., Civil Chamber, SC
4786-2020, 2020).
Several doubts arise from the above, since in this case
the argumentation was not used in the
ratio decidendi
of the
ruling, provided that in the specific situation force majeure
operated as an exonerating factor for liability. Then, the
question remains as to how the absence of informed consent
would operate in the liability trial, what are the consequences
the medical personnel would bear, is it possible to state that
the absence of informed consent is a necessary cause of the
damage, and does the absence of informed consent constitute
a relative nullity due to error in the medical services contract,
and if so, what are the consequences?
As can be seen, although the judgment brings up the
issue of informed consent and gives it special relevance, given
that no attempt had ever been made to incorporate this concept
within the liability trial, on this occasion, it does not make
much progress in this respect either, or the matter remains a
mere doctrinal reference.
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Considering the above, in the jurisprudence of the
Supreme Court of Justice it is irrelevant, within the liability
trial, whether the doctor provided the necessary information
for the patient to issue the respective consent, since, under the
logic, this has no direct impact on the practice, i.e., whether
the doctor was diligent and, therefore, acted with negligence.
However, the last judgment analysed the possibility of liability
based on the lack of informed consent but did not specify how
this could be done; this reference was only a doctrinal citation
(C. S. J., Civil Chamber, SC 4786-2020, 2020).
2.2.2. Third Section of the Council of State
Now, the dynamics of the jurisprudence of the Council
of State, as far as the assessment of informed consent is
concerned, have developed similarly. To explain this issue, we
will look at some cases that will be explained below.
On 3 April 2020 (C. E., Third Section, No. 43034,
2020), the Council of State studied a case in which a minor,
accompanied by his parents, went to the health service of
a hospital for a congenital cataract, for which the treating
ophthalmologist diagnosed that surgical intervention was
necessary. Indeed, the ordered procedure was carried out
correctly and following the urgency that the patient’s situation
required. However, days later, the child returned to the hospital
with an infection that, traditionally, could have been acquired
due to a lack of surgical asepsis and instruments in the post-
operative period. At that time, the procedure should have been
performed urgently, but a delay on the part of the medical staff
resulted in the child’s loss of vision. Furthermore, the hospital
had the burden of proof to demonstrate the correct application
of the procedures established in the protocols that mitigate
infectious diseases and timely care.
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However, the defendant failed to prove that the
protocols had been applied, that the delay of the medical
staff had not caused the damage and, additionally, there was
no evidence of the informed consent of the child’s parents
throughout the proceedings. Regarding the latter, the judge
considered that this act was reproachable, but did not give it
any effect other than considering it a negligent act among the
many others committed by the hospital (C. E., Third Section,
No. 43034, 2020). Thus, the lack of sterilisation measures and
the delay in care were the facts that constituted the evidence of
service failure for which the State was condemned.
In a judgment of 11 March 2019 (C. E., Third Section,
No. 46283, 2019), a case was decided in which a woman went
to the health service of a hospital because she presented a mass
in her neck; consequently, the treatment physician diagnosed a
“thyroid goitre” and the need for a surgical procedure to reduce
the thyroid gland. After the procedure, the patient noticed a
loss of vocal ability, and, after consulting other professionals,
it was determined that the surgery had resulted in irreversible
damage to her vocal cords.
One of the claimant’s arguments was that the informed
consent had not been given correctly, however, the evidence
found that the patient had signed a document stating the risks
of the surgery, as well as, in the interrogation, she claimed to
have been informed about the surgery.
Thus, the judge, citing a ruling of 3 July 2007 (C. E.,
Third Section, No. 16098, 2007), indicated that the informed
consent acted as evidence that served as an exoneration of
liability, since, if the damage was the realisation of one of the
risks informed to the patient, the defendant entity should not
bear the damage suffered by the plaintiff, since the provision
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of information allows the risk of the medical activity to be
transferred to the patient. Accordingly, the state absolves the
state of liability (C. E., Third Section, No. 16098, 2007).
In a judgment of 26 October 2018 (C. E., Third Section,
No. 41144, 2018), the case of a man who went to the health
service with symptoms of respiratory distress was studied.
After some tests, the medical staff diagnosed gall bladder stones
and biliary inflammation, for which, in principle, hospitalisation
in intermediate care was ordered and then he was discharged.
After a few days, the patient had to return to the health service
twice due to gall bladder inflammation. On a final occasion,
the patient attended the emergency department where he
underwent unnecessary surgery to remove his gall bladder,
without his consent, which resulted in harm to his integrity.
In that order, the judge analysed informed consent as
a tool to determine whether an exemption from liability was
applicable (C. E., Third Section, No. 41144, 2018), however, as
mentioned, there was no evidence of consent for the surgery in
the file so that the State was condemned for the realisation of a
risk that it did not transfer with the patient’s authorisation. Apart
from this, the absence of informed consent had no other effect.
Thus, in the jurisprudence of the Council of State,
informed consent is used to determine whether the defendant
has acted diligently, intending to disprove the basis of service
failure. Thus, when it becomes evident that the doctors have not
provided the information on the procedures to be performed
or have done so, but inadequately, this only results in the
impossibility of using consent as an exoneration of liability, but
not as evidence that can autonomously determine negligence.
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3. INFORMED CONSENT AS AN ESSENTIAL ELEMENT IN
DEFINING THE APPLICABLE LIABILITY REGIME
Up to this point, after all the analysis carried out on
informed consent, it is barely evident that there is a logical
contradiction between what is established in international and
national provisions on patient autonomy and the recognition
that the high courts, in liability proceedings, attribute to
this figure. As can be seen in the previous lines, in civil
jurisprudence it is irrelevant, within the liability trial, whether
the doctor obtained the patient’s consent. This is a similar issue
in administrative matters, where it only functions as a means of
proof to exempt the State from liability.
In my opinion, the irrelevance of informed consent in
the liability trial is a matter that violates the fundamental and
legal rights of the victims, which should affect the analysis of the
arising of the indemnification obligation, whether it is a matter
of contractual liability, for the civil case, or non-contractual
liability, for the administrative case. Thus, the legal arguments
on which this criticism is based will be developed here.
To explain this, I will give the following example:
A pregnant woman presents with symptoms of labour,
which is why she decides to go to the medical service of an IPS
for treatment. Coincidentally, however, the patient arrives at the
emergency department when the obstetrician-gynaecologist in
charge, who is quite reputed in his profession and has written
several scientific articles on the practice of caesarean section
as an acceptable and suitable procedure for childbirth, is about
to finish his shift.
However, once the mother is admitted to the
emergency department and is ready to be attended to for a
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vaginal delivery, which can last between 6 or 10 hours, the
doctor orders a caesarean section, a surgical procedure that
takes approximately 1 hour. Now, all the above was carried
out without informing the patient in a clear, complete, and
sufficient manner about the reason for this procedure, its risks,
and benefits.
One day after the surgery, due to symptomatology of
infection, the medical staff noticed a lesion in the patient’s
intestines caused by the procedure, which is a risk inherent to
this type of surgery, and ignored the doctor’s carelessness.
Once the patient has recovered from the surgery and
after the days of incapacity caused by the injury, she decides
to consult her lawyer about the procedure that was performed,
for which he verifies the medical history and finds no evidence
of informed consent about the caesarean section, indicating
that the treating physician and the IPS violated her right to
be informed about the risks and benefits of the procedure.
Considering the above, the lawyer recommends filing a
liability suit for the damages caused by the uninformed surgical
procedure.
Well, in the light of the majority case law of the
Supreme Court of Justice, this case would not give rise to an
obligation to pay compensation, since the procedure that caused
the damage was performed by an expert and in compliance
with the
lex artis
, so that it is impossible to prove the doctor’s
fault, since, as the Court has mentioned, the lack of informed
consent is not sufficient to prove a breach. On the other hand,
considering the jurisprudence of the Council of State, in this
scenario compensation would not be possible either, as the
consent would only serve to demonstrate that the doctor was
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informed of the risk of injury and that, if this risk materialised,
it is not imputable to the State. Thus, it would be necessary
to demonstrate some other elements of negligence to prove
service failure.
The reasoning explained by each of the courts ignores
the two main functions of informed consent. The first has to
do with the fundamental right of all patients to decide on their
life and personal integrity, so that it is the duty of all doctors,
before any treatment, to provide information on the procedure
to be carried out, as well as to request the patient’s authorisation
about any action that is planned to be performed.
On the other hand, and approaching the basis of the
critique, another of the functions of informed consent is to
make the patient a co-participant in the medical treatment to
be performed. That is, whenever the patient is the one who
makes decisions about his or her health and personal integrity,
the authorisation that he or she gives to health professionals
makes him or her responsible for the risks that he or she has
been clearly and sufficiently informed of (García, 2018, p. 146).
One of the logical effects of consent, then, is that
the negative results of a treatment, whether therapeutic or
surgical, are covered in a scenario of self-responsibility of the
patient; after all, it is the patient who decides about his body
and personal integrity, so it would be wrong for the law to
hold the doctor responsible when he is not the one who makes
the decision; he only proposes a treatment and carries it out
following what has been informed. Based on the above, it is only
natural that only obligations of means arise from medical acts,
whereby professionals only commit themselves to use all their
knowledge and skills to achieve an end, but this does not mean
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that they guarantee it. Hence the preponderant jurisprudential
position that medical liability must be analysed according to a
subjective regime.
However, if a doctor performs a procedure without
informed consent, which means violating the patients’ right to
decide about their health and personal integrity, does the logic
of self-responsibility explained in the previous paragraph hold?
The answer is no, since it is not possible to hold a subject, in the
case of our example, the patient, is responsible for an act that is
not attributable to her and that was deliberately performed by
the health professional.
Then, when a doctor, having the obligation to do so, does
not obtain the patient’s informed consent for the performance
of a procedure, the latter must assume, in terms of liability, the
realisation of the risks produced by the act performed, as would
be, in our example, the surgical injury suffered by the patient.
This is provided that medical activity, whether we like it or not,
in certain cases involves risks and, therefore, is susceptible to
being analysed based on a strict liability regime. To conclude
otherwise on this point would be to disregard the fact that
people have the right to decide about their health and personal
integrity. This is one of the reasons why obstetric violence is a
recurrent practice in Latin American countries, as there is no
incentive for health professionals to obtain the authorisation of
patients before performing any procedure.
Now, it is true that in some judgements of the Supreme
Court of Justice, medical activity was erroneously qualified
as
- per se -
a dangerous activity (C. S. J., Civil Chamber, 14
March 1942 and 14 October 1959), for which I adhere to the
criticisms that were made on such a postulate, but not on
the same grounds. In debating these decisions, the doctrine
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resorted to arguments that the profession of medicine is based
on ethical-social,
“
do-gooder
”
and altruistic postulates. It was
also argued that, historically, strict liability had been designed
only for business activities, but not for professions as worthy
and desirable as medicine (C. Jaramillo, 2015, 131-142). To
tell the truth, these arguments are not valid today; as a rule,
medicine responds to market dynamics, but not to the altruistic
intentions of some individuals concerned about people’s health
and well-being. And when this is not the case, it is the State,
through its provision of services, that performs this service.
Moreover, strict liability does not apply to business activities,
it applies to dangerous activities, i.e., conduct that increases
the normal levels of risk, whether they are lucrative. Therefore
medicine, as a risky activity in certain circumstances, may come
under a strict liability regime.
In short, the arguments aimed at dismissing out of
hand the objective regime for medical liability are loaded with
a condescension that in legal terms is not relevant, so much
so that, in other latitudes, it has even been considered, in a
judgement, that the “medical profession has much of a priestly
nature” (T.S.E., Civil Chamber, STS 453/1991, 1991), a matter
that in a secular country has no relevance whatsoever, however
small or large it may be, all trades and professions have the
same value in social terms, so that these are not arguments to
determine the applicable liability regimes.
Thus, according to what has been explained, the patient
in our example could request the application of a strict liability
regime, since the doctor, having the obligation to do so, did not
provide the necessary information to obtain consent. The lack
of the patient’s authorisation for the surgery implies that the risk
of the medical activity was not transferred so the professional
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should be liable for the realisation of any risk arising from the
procedure performed.
However, it is important to clarify that medical liability
for the realisation of a risk that was not informed and, therefore,
consented to by the patient, must be conditioned by the fact
that the harm suffered by the patient must be a consequence
of the medical activity, not a result of the pathology suffered, a
matter that in some cases will imply a judicious and demanding
evidentiary exercise. In addition, a doctor or an IPS cannot
be judged objectively when the information provided, even
if erroneous, complies with the
lex artis ad hoc
, which means
considering what the doctor could reasonably have inferred at
the time of treating a given patient.
CONCLUSIONS
In short, it cannot be said,
per se,
that the
subjective
regime applies to all cases of medical liability, any more than it
can be said that,
per se,
the objective regime applies to all cases
of medical liability. This will depend on the factual analysis that
each case raises.
Thus, taking into account all of the above, the application
of the objective regime to cases of medical liability must take
into account the following assumptions: (i) the procedure
performed by the treating physician must involve an abnormal
level of risk, such as that arising from surgery, (ii) the treating
physician or the institution providing the health service failed
in its duty to provide clear, complete and sufficient information
to obtain the patient’s consent, and (iii) the damage for which
compensation is sought must be the realisation of one of the
risks of the treatment applied, and not an effect of the pathology
for which the patient sought the health service.
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On the other hand, and in anticipation of a possible
criticism of the above, let us remember that for the jurisprudence
of the Supreme Court of Justice, all medical liability takes place
in a contractual sphere, so that the regime of dangerous activities
is not applicable, but rather the classification of the obligations
of means and results. However, it is not possible to maintain the
above reasoning when in medical practice, informed consent
is disregarded, as this would be a fundamental requirement for
the existence of any contract. If a patient does not authorise
the treatment to be provided, there is no contract for lack of
the requirement of consent, so the activities carried out by the
physician or the IPS cannot be analysed from the perspective
of a negotiated agreement. Consequently, when one wants to
hold a subject liable for damage that is not the result of a breach
of contract, what is the applicable regime? The non-contractual
regime, in which liability for the exercise of dangerous activities
does exist.
In fact, in the already explained judgement of 7
December 2020 (C. S. J., Civil Chamber, SC 4786-2020, 2020),
the Court indicated that the absence of informed consent
engaged the liability of doctors but did not mention in what
way. Hence, it could be inferred, according to the current
jurisprudential line, that the judge believed that the lack of
informed consent gave rise to an obligation of result, but
this would be an important logical contradiction since it is
not possible to predicate the existence of a contract with the
deprivation of one of its requirements of existence: consent.
Consequently, attributing a role to informed consent in the
liability trial would mean recognising the possibility of applying
objective extra-contractual liability in the civil jurisdiction,
which would be quite a change in the jurisprudential paradigm.
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Thus, in effect, as established in article 26 of Law
1164 of 2007, the health care relationship generates an
obligation of means, which applies to the contractual and non-
contractual sphere, even though obligations of means in non-
contractual matters do not exist, but this is how the Council
of State has understood it, which for medical practice and the
exercise of administrative functions is quite correct. However,
as already indicated, and following the assumptions, the
violation of informed consent should give rise to the liability
regime for dangerous activities or exceptional risk, both in
the jurisprudence of the Supreme Court of Justice and in that
of the Council of State. This does not mean that the rule is
disregarded since the doctor’s obligation is one of the means if
the medical act is validated by the informed consent or by the
legal exceptions that allow the professional to act without it.
REFERENCES
Alpa, G. (2018).
Los principios de la responsabilidad civil
. Bogotá:
Temis.
Asamblea Médica Mundial. (1981).
Declaración de Lisboa de la
AMM sobre los Derechos del Paciente
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Received:
20/10/2020
Accepted:
28/05/2022
Jorge Enrique Cely León:
Independent legal researcher. External
lawyer, expert in State, Civil, Disciplinary, Administrative
and Fiscal Liability, with a master’s degree in Economic Law,
Economic Regulation and Economic Analysis of Law.
Email:
jorge.celyleon@gmail.com
City:
Bogotá
Country:
Colombia
ORCID:
https://orcid.org/0000-0002-1360-0406