IMPORTANCE OF CONSENT
IN
TREATMENT
Adv.C.K.SIVADASAN
M.A.(PMIR),
LL.B., PGDADR(NALSAR)., PGDT, DACT, DEM,C.Coun
CONSULTANT
(MEDICO-LEGAL & HOSPITAL ADMINISTRATION)
Email:cksdas@yahoo.co.in
----------------------------------------------------
IMPORTANCE OF CONSENT
IN TREATMENT
Is
there any legal validity for the
removal of uterus and other reproductive organs
(abdominal hysterectomy and bilateral salpingo-oopherectomy) of a
patient by means of a surgical procedure, who consented for doing diagnostic
surgical procedure (Eg:-“diagnostic and operative
laparoscopy, Laparotomy may be needed”, etc.) to the doctor, while
undergoing treatment for her menstrual problems? Is that patient eligible for
compensation from that doctor for such medical negligence? What type of
consent is ‘Legally Valid Consent’, which acquired by the doctor from the
patient and/or from responsible guardian of that patient and what time is the
appropriate time for acquiring such consent for providing treatment to that
patient? Whether filling the blank spaces and signature in a pre-prepared
consent form with general conditions in a manner applicable to treatment and
entrusting the doctor without any specific direction is valid and sufficient
for treatment?
Even
though the above subject has taken for analysis by different courts in
various countries while dealing with Medical Negligence Cases and provided
guidelines in this matter so as to give enlightenment to the professionals as
well as to the general public, there occurs an apparent chaotic thinking
about it.
Verdicts of Rogers vs. Whitaker(Australia);
Schoendorff
vs. Society of New York Hospital(New York); Canterbury vs. Spence(U.S);
Reibl vs. Hughes(U.S); Chester
vs. Afshar (UK); Chhatterton vs. Gerson(UK); Murray vs. McMurchy (Canada);
Nizam Institute of Medical Sciences
vs. Prasanth S. Dhanaka(Supreme Court of India); Samira Kohli vs. Dr.Prabha Manchanda(Supreme Court of
India); Dr.C.P.Sreekumar vs.
S.Ramanujam(Supreme Court of India); Dr.Ritu
Rawat vs. Tej Singh (Indraprastha Apollo Hospital case - Delhi High
Court); Dr.Sathy M.
Pillai vs. S. Sharma (National
Consumer Disputes Redressal Commission); Dr.B.N. Gurudev vs. Dr.N.
Ramanna(National Consumer Disputes Redressal Commission), etc. are leading
lights in this subject.
Two cardinal principles of medical ethics
are Patient Autonomy and Beneficence. We
can see that in most of the cases there occurs no dispute on the knowledge
and skill of the professional in the realm of his/her service and is proved
fact regarding their intention to provide relief to the patient from the
sufferings due to the disease but the contentious issue is always whether the
provided treatment is acceptable to the patient or not. Such things are
usually happens mainly because of the ignorance of the truth related with
relevance and importance of the inviolable nature of the patient’s right in
regard to his body and his right to decide whether he should undergo the
particular treatment or surgery or not, probably during the treatment of
diseases leading to harmful consequences to the patient. Another important
fact is ‘valid consent’ provides exemption from punishment, as per the legal
principles of Criminal Law and Law of Torts, based on the legal maxim “volenti non fit injuria”.
Consent is defined in the
Indian Contract Act as: “two or more persons are said to consent when they
agree upon the same thing in the same sense” and Free Consent as: “Consent is
said to be free when it is not caused by coercion, undue influence, fraud,
misrepresentation or mistake”. So the consent given by the patient with the
same knowledge on the subject after acquiring relevant information only shall
be reckoned as valid consent as per jurisprudential principles. ‘Informed
Consent’ is defined in Taber’s Cyclopedic Medical Dictionary as: “Consent
that is given by a person after receipt of the following information - the
nature and purpose of the proposed procedure or treatment; the expected
outcome and the likelihood of success; the risks; the alternatives to the
procedure and supporting information regarding those alternatives; and the
effect of no treatment or procedure, including the effect on the prognosis
and the material risks associated with no treatment. Also included are
instructions concerning what should be done if the procedure turns out to be
harmful or unsuccessful.”
The Code of Medical Ethics
laid down by the Medical Council of India (As per the Indian Medical Council
Act, 1956) contains a chapter relating to disciplinary action which
enumerates a list of responsibilities, violation of which will be
professional misconduct. Clause 13 of the said chapter: “Before performing an
operation the physician should obtain in writing the consent from the husband
or wife, parent or guardian in the case of a minor, or the patient himself as
the case may be. In an operation which may result in sterility the consent of
both husband and wife is needed.”
General Medical Council of
The English law on this
aspect is summarized in ‘Principles of Medical Law’ (published by Oxford
University Press – 2nd Edition, edited by Andrew Grubb): “Any
intentional touching of a person is unlawful and amounts to the tort of
battery unless it is justified by consent or other lawful authority. In
medical law, this means that a doctor may only carry out a medical treatment
or procedure which involves contact with a patient if there exists a valid
consent by the patient (or another person authorized by law to consent on his
behalf) or if the touching is permitted notwithstanding the absence of
consent.”
‘Gynaecology’ (2nd
Edition) edited by Robert W. Shah, describes ‘real consent’ with reference to
Gynaecologists as: “An increasingly important risk area for all doctors is
the question of consent. No-one may lay hands on another against their will
without running the risk of criminal prosecution for assault and, if injury
results, a civil action for damages for trespass or negligence. In the case
of a doctor, consent to any physical interference will readily be implied; a
woman must be assumed to consent to a normal physical examination if she
consults a Gynaecologist, in the absence of clear evidence of her refusal or
restriction of such examination. The problems arise when the Gynaecologist’s
intervention results in unfortunate side effects or permanent interference
with a function, whether or not any part of the body is removed. For example,
if the Gynaecologist agrees with the patient to perform a hysterectomy and
removes the ovaries without her specific consent, that will be a trespass and
an act of negligence.”
In reality professionals are persons with
deep knowledge in their subject, on the other side, patients are persons
without any knowledge upto certain extent on the same subject. Due to this
imbalance, it become difficult for the patient to comprehend, terms as well
as ideas used in the consent documents as intended by the doctors without
simplifications and further elaborate clarifications. Eg:-‘Laparotomy’ is a
surgical procedure to open up the abdomen to examine the abdominal organs and
aid diagnosis. But Doctors use the same term in Consent Documents as surgical
procedure to open up the abdomen necessary to treat medical conditions and
removal of related organs. Laparotomy may be either a diagnostic or
therapeutic. In the former, more often referred to as the exploratory
laparotomy, an exercise is undertaken to identify the nature of the disease.
In the latter, a therapeutic laparatomy is conducted after the cause has been
identified. When a specific operation say hysterectomy or
salpingo-oopherectomy is planned, laparotomy is merely the first step of the
procedure, followed by the actual specific operation, namely hysterectomy or
salpingo- oopherectomy. Depending upon the incision placement, laparotomy gives
access to any abdominal organ or space and is the first step in any major
diagnostic or therapeutic surgical procedure involving a) the lower port of
the digestive tract, b) liver, pancreas and spine, c) bladder, d) female
reproductive organs and e) retroperitonium. On the other hand, hysterectomy
and salpingo-oopherectomy follow laparotomy and are not themselves referred
to as laparotomy. Therefore, while considering plain meaning, when the
consent form refers to “diagnostic and operative laparoscopy and laparotomy
if needed”, it refers to a consent for a definite laparoscopy with a
contingent laparotomy if needed. In general sense, it is not possible to
reach a conclusion that it amount to consent for hysterectomy and
salpingo-oopherectomy surgery removing the uterus and ovaries/fallopian
tubes. Like that, in medical circles, it is well recognized that catch all
clause giving the surgeon permission to do anything necessary does not give
roving authority to remove whatever he fancies may be for the good of the
patient. The usages like “the informed choice left to the operating surgeon
depending on his/her discretion, after assessing the damage to the internal
organs, but subject to his/her exercising care and caution” and “such medical
treatment as is considered necessary for me for”, etc. are some examples on
this.
This type of shortfalls are very common
in most of the consent documents acquired by the doctors from their patients
and because of such incongruence the same consent documents become worthless
and provide no protection to their acts, even if they provide service in good
faith, due to the incapability to prove the same in judicial process. Based
on the guidance of courts, many professionals are started to utilize legal
knowledge for preparing Consent Documents, so as to make them legally valid
documents by minimizing such mistakes and experiences shows that such
practice yielded beneficial results to them.
A duty to impart information regarding the proposed
treatment is the right of every patient. The patient’s right of self-decision
shapes the boundaries of the duty to reveal. That right can be effectively
exercised only if the patient possesses enough information to enable an
intelligent choice. The scope of the physician’s communications to the
patient, then, must be measured by the patient’s need, and that need is the
information material to the decision. Thus the test for determining whether a
particular peril must be divulged is important materially to the patient’s
decisions for that all risks potentially affecting the decision must be
unmasked. A reasonable thinking in these subjects tells us it as a necessity
as well as a matter of the physician’s duty. It is a duty to warn of the
dangers lurking in the proposed treatment, and that is surely a facet of due
care. Much more, the patient’s reliance upon the physician is a trust of the
kind which traditionally has exacted obligations beyond those associated with
arms length transactions. His dependence upon the physician for information affecting
his well being, in the fiducial nature (the physician- patient) relationship
and it is physician’s duty, to reveal to the patient that which in his best
interests it is important that he should know and the choices with respect to
proposed therapy and the dangers inherently and potentially involve before
acquiring consent from him.
There
used to see some argument that organs removed were not ‘vital’ organs and
having regard to the advanced age of the patient virtually ‘redundant’ as
well as the treatment is determined by severity of the disease in some cases,
but the correctness or appropriateness of the treatment procedure, does not
make the treatment legal, in the absence of consent for the treatment.
The guidelines summarized by the
Honourable Supreme Court of India, in Samira Kohli vs. Dr.Prabha Manchanda is very relevant in
this context:
(i) A doctor has to seek and
secure the consent of the patient before commencing a ‘treatment’ (the term
‘treatment’ includes surgery also). The consent so obtained should be real
and valid, which means that: the patient should have the capacity and
competence to consent; his consent should be voluntary; and his consent
should be on the basis of adequate information concerning the nature of the
treatment procedure, so that he knows what is consenting to.
(ii) The ‘adequate
information’ to be furnished by the doctor (or a member of his team) who
treats the patient, should enable the patient to make a balanced judgment as
to whether he should submit himself to the particular treatment as to whether
he should submit himself to the particular treatment or not. This means that
the Doctor should disclose (a) nature and procedure of the treatment and its
purpose, benefits and effect; (b) alternatives if any available; (c) an
outline of the substantial risks; and (d) adverse consequences of refusing
treatment.
(iii) Consent given only for
a diagnostic procedure, cannot be considered as consent for therapeutic
treatment. Consent given for a specific treatment procedure will not be valid
for conducting some other treatment procedure. The fact that the unauthorized
additional surgery is beneficial to the patient, or that it would save
considerable time and expense to the patient, or would relieve the patient
from pain and suffering in future, are not grounds of defence in an action in
tort for negligence or assault and battery.
(iv) There can be a common
consent for diagnostic and operative procedures where they are contemplated.
There can also be a common consent for a particular surgical procedure and an
additional or further procedure that may become necessary during the course
of surgery.
(v) The nature and extent of information
to be furnished by the doctor to the patient to secure the consent need not
be of the stringent and high degree. It will depend upon the physical and
mental condition of the patient, the nature of treatment, and the risk and
consequences attached to the treatment.
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Sunday, 15 June 2014
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