1

CONSENT IN HEALTH CARE LAW -AN OVERVIEW

- JIZAMOL.P.R
Consent is perhaps the only principle that runs through all aspects of health care
provisions today. It represents the legal and ethical expression of the basic right to have one's
autonomy and self-determination. The element of consent is one of the critical issues in the
area of medical treatment today. In India in recent years there has been an increase in the
number of malpractice suits that have arisen because of lack of consent or inadequate consent
from the patients for various procedures. Many clinicians are unaware of the legal and ethical
requirements and clinical aspects of consent in Medicine in India. Unlike many other
countries, the Indian Statute Book does not contain separate legislation regarding age for
consent to medical treatment. It is well known that the patient must give valid consent to
medical treatment; and it is his prerogative to refuse treatment even if the said treatment will
save his or her life.

. Consent to treatment is the principle that a person must give their permission before they
receive any type of medical treatment or examination. This must be done on the basis of a
preliminary explanation by a clinician. 1.If the medical practitioner attempts to treat a person
without valid consent then he will be liable under both tort and criminal law. Patients must
give valid consent to medical treatment and it is his prerogative to refuse treatment even if the
said treatment will save his or her life. So, consent should be obtained to safe guard oneself
from future medical litigation, before examination of a patient for diagnosis, therapeutic
intervention, treatment and surgery.
Analysing how the concept and role of consent was born and developed we can see that
not only the Egyptian civilisation, the Greek and Roman, documents showed how the
doctor's intervention had, in some way, first to be approved by the patient. 2 The earliest
expression of this fundamental principle, based on autonomy, is found in the Nuremberg
Code of 19473.The code makes it mandatory to obtain voluntary and informed consent of
human subjects. Similarly, the Declaration of Helsinki adopted by the World Medical
Association in 1964 emphasizes the importance of obtaining freely given informed consent
for medical research by adequately informing the subjects of the aims, methods, anticipated
benefits, potential hazards, and discomforts that the study may entail. Several international
conventions and declarations have similarly ratified the importance of obtaining consent from
patients before testing and treatment.4
The foundation of the traditional theory of consent to treatment lies in the law of battery,
and is found in decisions of US courts as early as 1905.5Justice Cardozo offered what has
become perhaps the best-known statement of the principle of consent in the 1914 New York

1
. http:/www.nhs.uk/coditions /consent to treatment/pages/introduction.aspx
2
www.ncbi.nlm.nih.gov/pubmed/16602332
3
1947. Nuremberg Code: The Nuremberg Code was adopted immediately after World War II in response to medical and
experimental atrocities committed by the German Nazi regime.
4
KK Aggarwal, Real Consent and not Informed Consent Applicable in India Indian Journal of Clinical Practice, Vol. 25, No. 4, September
2014 ,Article 8 of European Convention on Human Rights
5
Pratt v. Davis, 79 N.E. 562 (1906)
 2

case of Schloendorff v. New York Hospital 6. “Every human being of adult years and sound
mind has a right to determine what shall be done with his own body: and a surgeon who
performs an operation without his patient’s consent commits an assault....” 7

Consent can make physical invasion lawful but the reality of such consent may be closely
scrutinized by the law and it is subject to certain policy limitations, consent will not normally
render legitimate a serious physical injury. Traditional doctor-patient relationship was one in
which the doctor and the patient were unequal bargaining partners in a contract for services
with the doctors special knowledge creating the advantage. Over the past decade a
considerable volume of litigation in common law countries has focussed on the consent issue
and as a result the doctrine of informed consent, as it has come to be called has assumed a
role of significance in the medical negligence debate. It is a doctrine which has shown every
sign of getting out from the difficulties, which we could see in the light of recent
judgements .Now, the doctor need to give the patient the complete knowledge which will
make him or her an equal bargaining partner. Thus informed consent is meant to transform
the essence of the doctor-patient relationship to a contractual one, as contractual relationships
are thought to promote individual autonomy and freedom of choice 8. The essential
ingredient for validity of the act which involves two persons, “consensus ad idem” which
means two persons are said to consent if they agree upon the same thing in the same sense. 9
Lord Diplock had stated that, consent is a state of mind personal to the patient whereby he
agrees to the violation of his bodily integrity. 10 Not every agreement to undergo treatment is
in law a valid consent because it may be based upon inadequate information to make a
meaningful decision whether to undergo the procedure.

The English courts have unreservedly accepted that a patients bodily integrity is inviolable
such that any physically invasive medical treatment or procedure however trivial, is unlawful
unless authorised by consent or other lawful authority. The common law application of
consent is not fully developed in India, although the Indian courts have often referred to these
principles. In such situations, obviously one has to refer to the principles of the Indian
Contract Act and the Indian Penal Code. The relationship between a medical professional and
his patient is a contract by parties competent to contract giving rise to contractual
obligations11

Every human being who is an adult and of sound mind has a right to determine what
should be done with his body. Therefore consent obtained should be legally valid. A doctor
who treats without valid consent will be liable under the tort and criminal laws. The law
presumes the doctor to be in a dominating position, hence the consent should be obtained
after providing all the necessary information. 

6
(1914),211 N.Y. 125, AT 126
7
Andrew Grub ,Principles of Medical law, Oxford University Press, 2004 , p.133
8
Stone AA. Informed Consent. Special Problems for Psychiatry. Hospital and Community Psychiatry. 1979;
9
Sec 13 of Indian Contract Act
10
Sidaway v. Bethlehem Royal Hospital Governors[1985]1AllER643,658,

11
. Omprakash V. Nandimath , Consent and medical treatment: The legal paradigm in India Indian J
Urol. 2009 Jul-Sep; 25(3): 343–347
 3

The doctor-patient relationship is a special type of contract which starts when a patient comes
to a doctor seeking medical care, and when the doctor starts treating the patient the contract
comes into being. One of the essential features of establishing a contract is consent, which
means "an agreement, compliance or permission given voluntarily without any
compulsion".12Although there is no legal definition of consent in Indian law, Sec. 13 of the
Indian Contract Act states that "two or more persons are said to consent when they agree
upon the same thing in the same sense". This has been reflected in Article 21 of the Indian
Constitution, which declares, "No person shall be deprived of his life or personal liberty
except according to the procedure established by law"13 The expression personal liberty under
Art. 21 is of the widest amplitude and covers a wide variety of rights, including the right to
live with human dignity and all that goes along with it, and any act which damages, injures,
or interferes with the use of any limb or faculty of a person, either permanently or
temporarily14.

Doctor-patient relationship and contract:

Doctor-patient relationship is based on certain principles of contract law in true commercial
sense in addition to trust and faith. An agreement enforceable by law is a ‘contract’. 15 When
one person signifies to another his willingness to do or to abstain from doing anything, with a
view to obtaining the assent of that other to such act or abstinence, he is said to make a
proposal. 16When the person to whom the proposal is made signifies his assent thereto, the
proposal is said to be accepted. A proposal, when accepted becomes a promise (here refers
to medical examination, diagnosis, procedure or operation, etc.).17 The person making the
proposal is called the “promisor” (here refers to “doctor”) and the person accepting the
proposal is called the “promisee” (here refers to “patient”).18 When, at the desire of the
promisor, the promisee or any other person has done or abstained from doing, or does, or
abstain from doing or promises to do or abstain from doing, something, such act or
abstinence or promise is called a consideration (here refers to “doctors fee”) for the
promise.19 Every promise and every set of promises forming the consideration for each other
is an agreement.20 All agreements are contracts if they are made by the free consent of
parties competent to contract, for a lawful consideration and with a lawful object and are
hereby not expressly declared to be void. 21 The most important aspect of this contract is
Ubermaie Fide (of utmost good faith),i.e. relationship between the parties is fiduciary

12
Pillay VV. Medical Law and Ethics. In: Handbook of Forensic Medicine and Toxicology. 13th Ed.
Hyderabad: Paras Publication; 2003. p. 24-5

13
http://www.indianjmedsci.org/article.asp?issn=0019-
5359;year=2005;volume=59;issue=2;spage=74;epage=78;aulast= Bastia

14
. Maneka Gandhi v Union of India. AIR 1978 SC 597

15
Section 2(h)
16
Section 2 (a)
17
Section 2 (b)
18
Section 2 (c)].
19
Section 2 (d)]
20
Section 2 (e)].
21
[Section 10]
 4

Consent, in terms of medical law may be described as the autonomous authorization of

intervention by individual patients undergoing medical or surgical treatment. Consent in the
context of a doctor-patient relationship, means the grant of permission by the patient on his
volition for an act to be carried out by the doctor, such as a diagnostic, surgical or therapeutic
procedure22
Types of consent
Implied Consent
Expressed Consent [May be oral or written]
Implied Consent
Not written, that is, its existence is not expressly asserted, but nonetheless, it is legally
effective. It is the most common type of consent in both general and hospital practice. It
implies consent to medical examination in a general sense but not to procedures more
complex than inspection, palpation and auscultation. Implied consent is apparent when a
patient comes to hospital or doctor’s clinic for treatment, it is also apparent in a case of
comatose patient requiring immediate treatment or a mentally incompetent patient requiring
treatment when legal guardian is not available.
Expressed Consent
The terms of which are stated in distinct and explicit language. It may be in oral or written
form.
Written should be preferred as it has the advantage of easy proof and permanent form. Oral
consent is also equally valid if properly witnessed .Oral consent should be taken in the
presence of a disinterested party like any literate paramedical staff e.g. nurse, pharmacist
Informed Consent
Doctor should inform the patient regarding: Diagnosis, Nature of treatment or procedure,
Risks involved, Prospects of success, Prognosis if the procedure is not performed, and
Alternative methods of treatment23
Loco Parentis
“To act in loco parentis [in place of the parent]” has come to mean not only “to act as a
surrogate for the parent,” but also, implicitly, “to act with the devotion, motivation, and
dedication of the parent” in the best interest of the child.
In an emergency involving children, when their parents or guardians are not available,
consent is taken from the person in charge of the child e.g. a school teacher can give consent
for treating a child who becomes sick during a picnic away from home town, or the consent
of the head master of a residential school.
22
supra n:4
23
Informed consent was practically non-existent till the time COPRA [Consumer protection
act] came into existence. This is seen as more of a legal requirement than the ethical moral
obligation on part of the doctor towards his patient.
 5

Proxy consent or surrogate decision maker

When a person is incapable of giving expressed consent a substituted consent can be taken
from the next of kin. Generally accepted order is spouse, adult child, parents, siblings, lawful
guardian .Consent of relative can also be taken if the consequence of informing the patient
about the disease is more dangerous as compared to the actual risk of the procedure.24

However, the common law application of consent is not fully developed in India, although
the Indian courts have often referred to these principles. In such situations, obviously one has
to refer to the principles of the Indian Contract Act and the Indian Penal Code
Common meaning of consent is permission whereas the law perceives it as a contract i.e. an
agreement enforceable by law. Consent to treatment is the principle that a person must give
their permission before they receive any type of medical treatment or examination. This must
be done on the basis of a preliminary explanation by a clinician.25
The validity of the consent is based on 3 elements:

 Voluntariness
 Capacity
 Knowledge

1. Voluntariness
Patients should give consent completely voluntarily without any force either from the Doctor
or any third party (e.g. relatives). According to Sec. 14 of the Indian Contract Act, consent is
said to be free when it is not caused by coercion (Sec.15), undue influence (Sec.16), fraud
(Sec.17), misrepresentation (Sec.18) and mistake (Sec.19). Consent obtained with
compulsion either by the action or words of the doctor or others is no consent at all.
Especially in our country we need to keep in mind that initiative to the treatment may not be
of the patient she and she may be coerced by relatives into giving consent. Here the Doctors
have to ensure voluntariness of the consent.

2. Capacity to Consent
The patient should be in a position to understand the nature and implication of the proposed
treatment, including its consequences. In this regard the law requires following special
considerations.

a. Age of Consent

Consent is a contract and to make a valid contract both the parties must have attained
majority. The Indian Majority Act, 1875 declares that every person domiciled in India shall
be deemed to have attained majority when he/she has completed 18 years of age. According
to Sec. 11 of the Indian Contract Act "Every person is competent to contract who is of the age
of majority according to the law to which he is the subject, and who is of sound mind and is
24
Kohli A:Medical consent in India-Ethical and legal issues; Anil Aggarwal’s Internet
Journal of Forensic Medicine and Toxicology,2007,vol.1[2],July-December,2007]
25
http://www.nhs.uk/conditions/consent-to-treatment/pages/introduction.aspx
 6

not disqualified from contracting by any law to which he is the subject". In our country only a
person who is a major by law i.e. above the age of 18 can give valid consent for the
treatment. Hence any person who is a minor, cannot legally give consent. The concept of a
“mature minor” i.e. a minor who is mature enough to understand the implications of his or
her treatment though well established in some western countries 26 is not routinely recognized
in our country. It is also important for a Doctor to remember that even though a minor may
represent himself/herself as a major even then the onus of finding out whether the patient is
minor or not is on the physician.
But according to Section 90 IPC a child less than twelve years of age or insane person cannot
give valid consent. By implication from Section 90 IPC, one can say that in general a boy or
girl can consent to medical or surgical treatment if he or she is above twelve years of age
provided the treatment is intended for his or her benefit and is undertaken in good faith.
Section 88 and Section 90 of the IPC suggest that the age for giving valid consent for any
medical procedure is twelve years. Hence a doctor taking consent for medical or surgical
treatment from a person aged twelve years or more can be legally said to have taken a valid
consent and cannot be held criminally liable on this account. However Sections 87 IPC
mentions eighteen years as the age for giving consent for acts not intended and not known to
be likely to cause death or grievous hurt. These acts are not necessarily for the benefit of the
person. Hence Section 87 IPC is not applicable to the medical profession as here (in Section
87 IPC), the acts are NOT done for the person's benefit.
b. Mental Incapacity

It is well accepted that a person should be mentally capable to give consent for his or her own
treatment. This implies that patients who are mentally retarded or mentally incapable due to
any diseases, process may not be capable of giving their own consent. In such cases consent
from the legal guardian is essential.
As per Sec. 12 of the Indian Contract Act "A person is said to be of sound mind for the
purpose of making a contract, if at the time he makes it, he is capable of understanding it and
of forming a rational judgment as to its effect upon his interest". So a person in the lucid
interval can make a valid contract. The fact that the person is mentally ill, or has learning
difficulties is not in itself sufficient ground to determine that he is not competent. If he
possesses sensory and mental powers to process the information, data and to derive a
conclusion he can give a valid consent.
Patients under the influence of alcohol or drugs as well as patients suffering from extreme
pain form a separate category; validity of consent in such situations is liable to be questioned.
3. Knowledge Forms the Crux of the Matter Regarding the Consent
It includes:
• Nature of the diagnosis
• Nature of treatment planned
Foreseeable risk involved in the treatment
• Prognosis if treatment is not carried out
26
Gillick v. Wisbechand Norfolk AHA [ 1985]3AllER402(HL)
 7

• Any alternative therapy available.

It is duty of a Doctor to disclose all these points to the patients so that patients may exercise
his right to self-determination about the proposed course of the treatment. The consent must
be to do a lawful act and it must not disobey any provision of the law 27. The consent must not
be against morality or public policy28.
Unilaterally executed consents are void. Consent being an agreement between two or
more persons, all concerned parties must execute the same. The doctor himself must take the
consent because this is a contract between the doctor and the patient. Consent signed only by
the patient and not by the doctor is null and void. In case of minors the consent of one parent
is sufficient vide 89 IPC. While treating the inmates of a hostel, the consent of the warden or
the principal of the school should be taken (loco parentis). As per the MTP Act of 1971,
consent of the guardian is mandatory to terminate the pregnancy of a minor girl. But if the
girl is not willing then the pregnancy should never be terminated. In case of a married woman
pregnancy can never be terminated at the request of her husband. But, if the woman is
consenting, consent of the husband is not mandatory .For the purpose of the treatment of
either husband or the wife, consent of the person to be treated should be taken. But in case of
any treatment or operation, when the loss of potency or fertility is involved, it is always
advisable to take the consent of both the spouses .When an unknown person brings an
accident victim in a serious condition to the hospital, he should not be asked to sign the
consent form, but his identity must be noted in the medical record. In such circumstances, if
possible, consent can be obtained from the relatives by telephone. If this is not possible then
the doctor should go ahead with the operation for the best interest of the patient. For the
purpose of transplantation of human organs, consent of the donor is required. In case of
cadaver transplantation, however, consent of the next kith and kin is required, even though
directive is available mentioning the wishes of the deceased about his organs to be
transplanted. . Consent can be taken immediately before the specific procedure in emergency
situations. But in case of elective procedures, it should preferably be taken at least a day or
two before. On the day of the operation a patient may not be considered mentally sound to
execute a contract when he is not likely to be in the right frame of mind. Consents duly
witnessed and signed by uninterested third parties are more dependable legally, as the parties
concerned cannot subsequently deny execution. Nurses, assistants and medical students
cannot always be considered as uninterested third parties. The court may question their
interest. The same also holds good regarding the patient's relatives.29

For further clarity we could say that the consent obtained by the doctor should have:
Specificity30, Full disclosure must be there for consent to be legally valid. There should not
be any suppression of facts. Legal standards may require physicians to disclose information
that a reasonable practitioner in a similar situation would disclose ('professional standard of

27
Consent for euthanasia is null and void in India
28
Performing sterilization operation on a prostitute, with consent. 
29
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2779959/#CIT8
30
The consent must be person- and procedure-specific. The consent is an agreement between
a doctor and a patient. The consent is not valid if the assistant does an operation when the
patient has consented to be operated on by a particular doctor. Similarly, when the consent is
for a particular procedure, the doctor cannot perform another without a fresh consent.
 8

disclosure'), or information that a reasonable patient would find material to his or her decision
('materiality standard'). Exceptions to disclosure requirements are:

a. Emergencies: When the time required for disclosure would create a substantial risk of harm
to the patient or third parties, full disclosure requirements may not apply.

b. Waiver: Patients may waive their rights to receive information. This should be a
knowledgeable waiver, i.e. patients should be made aware that they have a right to receive the
information, to designate a surrogate to receive the information, or to be informed at a later
date.

c. Therapeutic privilege: Information can be withheld, when disclosure per se would be likely
to cause harm to patients (e.g. when a patient with an unstable cardiac arrhythmia would have
his or her situation exacerbated by the anxiety attendant on full disclosure of the risk of
treatment). In emotionally disturbed patients the doctor should request a specialist
consultation to establish that the patient is emotionally disturbed. The doctor should also note
his decision in the patient's records explaining his intentions and the reasons for it.

d. Incompetence: Incompetent patients may not, as a matter of law, give an informed consent.
State law generally provides alternative mechanisms by which consent can be obtained, and
requires disclosure to a substitute decision-maker.

e. Involuntary treatment: Many states allow psychiatric treatment to occur without patients'
informed consent. This occurs most commonly when patients' refusals of treatment are
specifically overridden following clinical, administrative, or judicial review.

The relationship between a medical professional and his patient is a contract by parties
competent to contract giving rise to contractual obligations. Parties are generally competent
(in accordance with the Indian Majority Act) (i) if they have attained the age of 18, (ii) are of
sound mind, and (iii) are not disqualified by any law to which they are subject to.
Furthermore, there is a stipulation in the contract law stating that consent of any party (in our
case it is the patient) that is obtained by coercion, undue-influence, mistake,
misrepresentation or fraud, will render the agreement invalid.

But unfortunately the Indian Statue Book does not contain separate legislation regarding
consent to medical treatment nor do the various acts relating to majority, minority and
guardianship throw any light on the subject. As a result, the laws for consent in general are
also being applied to the medical profession.

According to Section 90 IPC a child less than twelve years of age or insane person cannot
give valid consent.

By implication from Section 90 IPC, one can say that in general a boy or girl can consent to
medical or surgical treatment if he or she is above twelve years of age provided the treatment
is intended for his or her benefit and is undertaken in good faith.

Section 88 and Section 90 of the IPC suggest that the age for giving valid consent for any
medical procedure is twelve years. Hence a doctor taking consent for medical or surgical
treatment from a person aged twelve years or more can be legally said to have taken a valid
consent and cannot be held criminally liable on this account.
 9

However Sections 87 IPC mentions eighteen years as the age for giving consent for acts not
intended and not known to be likely to cause death or grievous hurt. These acts are not
necessarily for the benefit of the person. Hence Section 87 IPC is not applicable to the
medical profession as here (in Section 87 IPC), the acts are NOT done for the person's
benefit.

Another school of thought however feels that valid consent can only be given at or above
eighteen years of age.31 They feel that consent is a contract between two parties and as the
Indian Contract Act states that to enter into a contract both parties must be at least eighteen
years of age, this should be the age for giving valid consent in medicine. However it should
be noted that the Indian Contract Act is for conditions like marriages, financial agreements
etc. and is not specific for the medical profession.

Similarly, Section 92 of the IPC offers legal immunity to a registered medical practitioner
to proceed with appropriate treatment even without the consent of the patient in an
emergency when the victim is incapable of understanding the nature of the treatment or when
there are no legal heirs to sign the consent. If the patient is conscious and refuses treatment
without which that person might endanger his/her life, then the surgeon can inform the
judicial magistrate and get the sovereign power of guardianship over persons under disability
(parens patriae).32
Further, Section 375 of the IPC exempts the husband of a girl above the age of 15 years
from indictment of rape, even if he has sexual intercourse with her against her will.
Nevertheless, a girl under 18 years of age cannot give valid consent to undergo medical
termination of pregnancy as per the Medical Termination of Pregnancy (MTP) Act, 1971
(Sec (3) (4) (a)).We could see the absence of firm and unambiguous legal provisions
regarding consent in relation to the medical treatment is reflected (As per provisions of the
MTP Act, only a girl above 18 years can give consent to undergo abortion. But the onus of
verifying the age is not on the doctor. The usual convention is that a person can give consent
for general physical examination after 12 years of age and for surgery after 18 years of age.
The difference in these views needs an explanation. Section 88 of the IPC, which is
specifically meant for doctors –when read with Section 90 IPC –, suggests that the valid age
of consent is 12 years, if the act is done in good faith for the benefit of the person (e.g.
surgery). Thus, it would appear that a person could give valid consent for surgery at 12 years.
However, in such cases, although a criminal charge cannot be brought against him, but civil
suit can be initiated for damages because a child below 18 years cannot enter into a valid
contract. Criminal law in India put doctors on different footings and provided protection from
criminal cases in General Exceptions which cannot be basis of routine medical practice in
India. 33
However it should be noted that the Indian Contract Act is for conditions like marriages,
financial agreements etc. and is not specific for the medical profession. Further, even though

31
Bastia BK, Kuruvilla A, Saralaya KM. Validity of consent- A review of statutes. Indian J
Med Sci. 2005 Feb
32
Charan Lal Sahu and others v. Union of India (AIR 1990 SC 1480)
33
K ARUNAKARAN MATHIHARAN, A need for clarity Law on consent and confidentiality in India: THE NATIONAL
MEDICAL JOURNAL OF INDIA,VOL. 27, NO. 1, 2014
 10

consent is said to be a contract (under Indian Contract Act), various Acts do not override the
Indian Penal Code. If a person analyses the history of laws relating to health services, we can
understand that no other field has undergone sweeping changes as the health sector. There is
a u-turn in the concept of contractual obligations between a medical professional and his
patient. For example, Section-16 of the Indian Contract Act 1872, which had hitherto
considered doctor-patient relations as ‘fiduciary relationship’; has been completely denied its
dominance because of the judgment and order in VP Shantha v/s Indian Medical Association
of India34. It redefined the relationship between doctor-patient as a contractual obligation
between two different distinct, equal parties.  It has completely revoked the fiduciary
relationship between them i.e., the doctor having an undue influence over the thinking
process of patient so far.
Those doctors who do consider consent to be a contract take the consent of the parent or
guardian for medical procedures in which death or grievous injury can occur when the age of
the patient is less than eighteen years. They feel this will be of benefit in cases involving civil
liability. Here the decision of House of Lords in the famous case, Gillick v. West Norfolk and
Wisbech35, need to be analysed. It was stated that capacity is a question of fact in every case
and requires that if the patient is able to understand what is involved in the decision to be
taken .then it amounts to valid consent. Thus in the case of children, the validity of consent is
based on whether the patient has acquired sufficient maturity and intelligence to understand
what is involved.36

LIABLITY UNDER TORT AND CRIME

If a medical practitioner attempts to treat a person without valid consent, then he will be
liable under both tort and criminal law. Tort is a civil wrong for which the aggrieved party
may seek compensation from the wrong doer. Crime is an action or omission which
constitutes an offence which is punishable under law. Mensrea and Actus reus play an
important role in deciding the cases of criminal liability. The consequences would be
payment of compensation (in civil) and imprisonment (in criminal).

To commence, the patient may sue the medical practitioner in tort for trespass to person.
Alternatively, the health professional may be sued for negligence.

In tort law, usage of force against any human body, without proper justification, is
actionable irrespective of the quantum of force. If the medical practitioner attempts to treat a
patient without obtaining proper consent, he will be held guilty under tort law. But this is not
the end of story. Any purported consent must also meet the requirements of the tort of
negligence. Negligence is not concerned with the presence or absence of consent, but with
the defendant’s failure to comply with a legally imposed duty of care.

NEGLIGENCE-IN TORT

34
http://ehealth.eletsonline.com/2009/12/11348/#sthash.m5mstDeA.dpuf
35
[ 1985]3AllER402,
36
Supran:7 ,p.160
 11

Winfield37has defined negligence as a tort which is the breach of a legal duty to take care
which results in damage, undesired by the defendant to the plaintiff. An act to be negligent,
two matters must be established

 that a legal duty exists

 breach of that duty (quantum of care demanded).

The duty exist not to harm the patient through careless acts. But what is considered here are
not the doctor’s acts. Instead the concern is with what doctor must do prior to acting so as to
ensure that proper consent has been given for those acts. The concern is with the knowledge
or information which the patient is entitled to be given (assuming the patient to be competent)
before any purported consent is valid. Thus the main question is whether it was carried out
with proper permission.38 Thus in an action for negligence / battery for performance of an
unauthorized surgical procedure, the Doctor can put forth as defence the consent given for a
particular operative procedure, as consent for any additional or further operation.

Negligence mechanism is a great development at common law which occurs

throughout the20th century.39 The root of professional negligence can be found in the case of
Donoghue v. Stevenson,40 where a woman succeeded in establishing that a manufacturer of
ginger beer owed her a duty of care, where it had been negligently produced. Following this,
the duty concept has expanded into a coherent judicial test, which must be satisfied in order
to claim in negligence. A medical professional is expected to have the requisite degree of
skill and knowledge. The rule in professional negligence is a little different, for professionals
such as medical practitioners an additional perspective is added through a test known as the
Bolam41 test which is the accepted test in India. A doctor is not guilty of negligence if he has
acted in accordance with a practice accepted as proper by a responsible body of medical men
skilled in that particular act.

This approach has been accepted in the judgment of the Indian Supreme Court in the case of
Jacob Mathew v. State of Punjab.42The standard of care, when assessing the practice as
adopted is judged in the light of the knowledge available at the time of the incident, and not
at the date of trial.

The duty of care for a medical professional starts from the time the patient gives an implied
consent for his treatment and the medical professional accepts him as a patient for treatment,
irrespective of financial considerations. This duty starts from taking the history of the patient
and covers all aspects of the treatment, like writing proper case notes, performing proper
clinical examination, advising necessary test and investigations, making a proper diagnosis,
and carrying out careful treatment43
CRIMINAL NEGLIGENCE

37
Winfield and Jalou.icz, Tort,5th , p.4.
38
Ibid ,p.179
39
Derry v. Bonney, 38 Wn.2d 876, 231 p. 2d 637, Wash, 1951.
40
Donoghue v. Stevenson[1932] AC 562.
41
Bolam v. Friern Hospital Management Committee, [1957] 1 WLR.
42
Supra n10.
43
Abdul Rahman, Medical negligence and doctor's liability, Indian J Med Ethics. 2005 Apr-Jun; 2(2)
 12

With the awareness in the society and the people in general gathering consciousness about
their rights, measures for damages in tort, civil suits and criminal proceedings are on the
augment. Not only civil suits are filed, the accessibility of a medium for grievance redressal
under the Consumer Protection Act, 1986 (CPA), having jurisdiction to hear complaints
against medical professionals for 'deficiency in service', has given rise to a large number of
complaints against doctors, being filed by the persons feeling aggrieved. The criminal
complaints are being filed against doctors alleging commission of offences punishable under
Sec. 304A or Sections 336/337/338 of the Indian Penal Code, 1860 (IPC) alleging rashness or
negligence on the part of the doctors resulting in loss of life or injury of varying degree to the
patient.
Section 304A of the Indian Penal Code of 1860 states that whoever causes the death of a
person by a rash or negligent act not amounting to culpable homicide shall be punished with
imprisonment for a term of two years, or with a fine, or with both.
In the Santra case44, the Supreme Court has pointed out that liability in civil law is based
upon the amount of damages incurred; in criminal law, the amount and degree of negligence
is a factor in determining liability. However, certain elements must be established to
determine criminal liability in any particular case, the motive of the offence, the magnitude of
the offence, and the character of the offender.
In Poonam Verma vs Ashwin Patel the Supreme Court distinguished between negligence,
rashness, and recklessness.45 A negligent person is one who inadvertently commits an act of
omission and violates a positive duty. A person who is rash knows the consequences but
foolishly thinks that they will not occur as a result of her/ his act. A reckless person knows
the consequences but does not care whether or not they result from her/ his act. Any conduct
falling short of recklessness and deliberate wrongdoing should not be the subject of criminal
liability.
Thus a doctor cannot be held criminally responsible for a patient’s death unless it is shown
that she/ he was negligent or incompetent, with such disregard for the life and safety of his
patient that it amounted to a crime against the State.46
Sections 80 and 88 of the Indian Penal Code contain defences for doctors accused of criminal
liability. Under Section 80 (accident in doing a lawful act) nothing is an offence that is done
by accident or misfortune and without any criminal intention or knowledge in the doing of a
lawful act in a lawful manner by lawful means and with proper care and caution. According
to Section 88, a person cannot be accused of an offence if she/ he performs an act in good
faith for the other’s benefit, does not intend to cause harm even if there is a risk, and the
patient has explicitly or implicitly given consent
For an act to amount to criminal negligence, the degree of negligence should be much
higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher
degree may provide a ground for action in civil law but cannot form the basis for prosecution.
The word 'gross' has not been used in Section 304A of IPC, yet it is settled that in criminal
law negligence or recklessness, to be so held, must be of such a high degree as to be 'gross'.
44
State of Haryana vs. Smt. Santra (2000) 5 SCC 182:: AIR 2000 SC 3335

45
Poonam Verma vs Ashwin Patel (1996) 4 SCC 332

46
http:/www.ijme.in/index.php/ijme/article/view/592/1506.
 13

The expression 'rash or negligent act' as occurring in Section 304A of the IPC has to be read
as qualified by the word ‘grossly’) Conviction for any substantial criminal offence requires
that the accused person should have acted with a morally blameworthy state of mind.
Recklessness and deliberate wrongdoing are morally blameworthy, but any conduct falling
short of that should not be the subject of criminal liability. Common-law systems have
traditionally only made negligence the subject of criminal sanction when the level of
negligence has been high a standard traditionally described as gross negligence. In fact,
negligence at that level is likely to be indistinguishable from recklessness. To prosecute a
medical professional for negligence under criminal law it must be shown that the accused did
something or failed to do something which in the given facts and circumstances no medical
professional in his ordinary senses and prudence would have done or failed to do. The hazard
taken by the accused doctor should be of such a nature that the injury which resulted was
most likely imminent. Res ipsa loquitur is only a rule of evidence and operates in the domain
of civil law especially in cases of torts and helps in determining the onus of proof in actions
relating to negligence. It cannot be pressed in service for determining per se the liability for
negligence within the domain of criminal law. Res ipsa loquitur has, if at all, a limited
application in trial on a charge of criminal negligence.
ASSAULT AND BATTERY
The intentional interference with the person of another without legal justification amount to
an actionable assault and battery for which damages may be recoverable by the injured
person. Such damages will of course include compensation for actual injuries suffered as the
result of the assault but in addition a Judge or Jury is at liberty in a proper case to award the
plaintiff exemplary damages in respect of an assault or battery as a means of punishing the
defendant for reprehensible conduct in invading the Plaintiff’s personal right without
justification. Bodily interference which would otherwise amount to an assault or battery may,
however, be justified by showing that the “patient” voluntarily submitted to the conduct in
question. No action lies, therefore, against a medical man who interferes with the person of a
patient if the patient’s consent to the interference has been obtained. But for a medical man to
administer treatment to or perform an operation upon a patient without the latter’s consent
amounts, subject to some exceptions which will be noticed in due course, to an actionable
assault 47

The traditional definition of battery is an act that directly and either intentionally or
negligently causes some physical contact with another person without that person's consent.

The essential requirements are:

 There should be use of force

 The same should be without legal justification

If a person has consented to contact expressly or by implication, then there is no battery. It is

a rare case in which a doctor would be held liable for criminal breach, unless there is gross
disrespect to the patient's bodily autonomy, for instance, if a patient's organs are taken
without his consent. The consent obtained, of course, after getting the relevant information
will have its own parameter of operation to render protection to the medical practitioner. If

47
Glanville Williams in his Textbook on Criminal Law, 7th Edition, at page 568
 14

the doctor goes beyond these parameters, he would be treating the patient at his risk, as it is
deemed that there is no consent for such treatment at all. A doctor who went ahead in treating
a patient, to protect the patient's own interest, was held liable as he was operating without
consent.48

This case law also signifies the traditional notion of paternalism prevalent among the
members of the medical fraternity. It is a notion where the doctor takes-up the role of a parent
of the patient and starts deciding on behalf of the patient himself. Unfortunately, the law does
not accept this notion. The first priority of law is always the right of autonomy of the patient
provided he is endowed with necessary capacity. A medical practitioner who believes that a
medical procedure is appropriate and necessary for a patient's well-being can perhaps be
forgiven for believing that the principle of autonomy should be sacrificed in the best interest
of the patient. 49Regarding proxy consent, when the patient is unable to give consent himself,
there are no clear regulations or principles developed in India. If such a situation exists, the
medical practitioner may proceed with treatment by taking the consent of any relative of the
patient or even an attendant.50

Liability under the Consumer Protection Act

In 1995, the Supreme Court decision in Indian Medical Association v VP Shantha brought
the medical profession within the ambit of a 'service' as defined in the Consumer Protection
Act, 1986. This defined the relationship between patients and medical professionals as
contractual. Patients who had sustained injuries in the course of treatment could now sue
doctors in 'procedure-free' consumer protection courts for compensation.

• The Court held that even though services rendered by medical practitioners are of a
personal nature they cannot be treated as contracts of personal service (which are excluded
from the Consumer Protection Act). They are contracts for service, under which a doctor
too can be sued in Consumer Protection Courts.
• A 'contract for service' implies a contract whereby one party undertakes to render
services (such as professional or technical services) to another, in which the service
provider is not subjected to a detailed direction and control. The provider exercises
professional or technical skill and uses his or her own knowledge and discretion. A
'contract of service' implies a relationship of master and servant and involves an obligation
to obey orders in the work to be performed and as to its mode and manner of performance.
The 'contract of service' is beyond the ambit of the Consumer Protection Act, 1986, under
Section 2(1) (o) of the Act.
• The Consumer Protection Act will not come to the rescue of patients if the service is
rendered free of charge, or if they have paid only a nominal registration fee. However, if
patients' charges are waived because of their incapacity to pay, they are considered to be
consumers and can sue under the Consumer Protection Act. . It is also easier for people to
force negligent doctors to Consumer Protection Forums.

JUDICAL PRNOUNCEMENTS ON CONSENT ISSUE

48
Ram Bihari Lal v Dr. J. N. Srivastava. AIR 1985 MP 150.
49
Mill, J.S., ‘On Liberty’ Harmondsworth: Penguin; 1982. p. 68.
50
C A Muthu Krishnan v M. Rajyalakshmi. AIR 1999 AP 311.
 15

In Nizam’s Institute of Medical Sciences v. Prasanth S. Dhananka51,. The hospital and the
surgeon were held liable for negligence.as consent was not taken for removal of tumour but
only for excision biopsy

Recently, a three judges bench of the Supreme Court of India, awarded a compensation of
Rs.25,000 and waiver of surgery fees to a women whose uterus was removed by a lady
obstetrician without her consent.52

Indian Supreme Court in Rajkot Municipal Case53held that if the claim depends upon proof of
contract, action does not lie in tort. If the claim arises from relationship between the parties
independent of the contract, an action would lie in tort at the election of the plaintiff, although
he might alternatively have pleaded in contract

In Ram Biharilal’s case—the surgeon did not explain the hazards of chloroform anesthesia
before taking consent of the patient for operation of appendicitis. On finding the appendix to
be normal, he proceeded to remove the gallbladder without consent and risking the ill effects
of the patient under chloroform. In this case the surgeon was held negligent.54

The Chandra Shukla v Union of India, it was held that if there are no circumstances for a
doctor to sense foul play or doubt about the capacity of the patient, he is protected.55. .

In Dr. T.T. Thomas vs. Elisa,(15The court delivered a verdict in favour of the plaintiffs stating
that consent under such an emergent situation is not mandatory.

Situations Where Consent May not be Obtained

• Medical Emergencies: The wellbeing of the patient is paramount and medical rather than
the legal considerations come first. It may not be necessary to obtain a consent obtain
where lifesaving procedures are to be undertaken for example:
— In an accident case;
— In a major surgery or post-surgery where additional emergency procedures are
required, as for example, doing a tracheostomy to ease breathing.
• In case of person suffering from a notifiable disease56
• Members of Armed Forces
• New admissions to prisons
51
(2009) 6 SCC 1.
52
Samira Kohli v. Prabha Manchanda, (2008) 2 SCC 1.
53
Rajkot Municipal Corporation v. Manjul Ben Jayantilal Nakum, (1997) 9SCC, 1997. 1.
54
Ram Behari Lal V Dr JN Srivastava AIR 1985 MP 150, ACJ.
55
AIR 1987 ACJ 628.
The relationship between the patient and his wife were strained. A patient was operated on for sterilization.
While giving consent he deposed that he is married and has two baby girls. In fact, he was undergoing an
operation only for getting the money as incentive. After the operation, his father contended that the patient was
of unstable mind and was not competent to give consent.
56
. In case of AIDS/HIV positive patients, the position in India regarding its being a notifiable disease or not is
not yet clear. However, the Supreme Court in Mr. X v. Hospital Z has held that wherever there is a danger of
transmitting HIV infection to the ‘would be spouse’, the doctor/hospital would be under a duty to inform the
‘would be spouse’, of the danger. Rather, not doing so would make the doctor/hospital participiens criminis
under sections 269 and 270 of IPC
 16

• In case of a person where a court may order for psychiatric examination or treatment.
• Under section 53(1) of the Code of Criminal Procedures, a person can be examined at
request of the police, by use of force. Section 53(2) lays that whenever a female is to be
examined, it shall be made only by, or under the supervision of a female doctor.

The Question Which Consent Is Applicable In India: Real Or Informed?

In the Samira Kohli vs. Dr. Prabha Manchanda and Ors 57, the Hon’ble Supreme Court of
India observed: 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. The only
exception to this rule is where the additional procedure though unauthorized, is necessary in
order to save the life or preserve the health of the patient and it would be unreasonable to
delay such unauthorized procedure until patient regains consciousness and takes a decision.
For the patients to play a significant role in decision making they must have adequate
information. .In India, real consent and not informed consent is applicable. The components
of real consent as stated by the Hon’ble Supreme Court of India are: “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.”
As per Supreme Court of India, “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
mentioned in Canterbury58 (informed consent) but should be of the extent which is accepted
as normal and proper by a body of medical men skilled and experienced in the particular
field. 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.” Global scenario and
Trends are shifting from 'real consent’ concept evolved in Bolam and Sidaway to the
'reasonably prudent patient test' in Canterbury.
The court consciously preferred the ‘real consent’ concept evolved in Bolam and Sidaway in
preference to the ‘reasonably prudent patient test’ in Canterbury, having regard to the ground
realities in medical and health-care in India. But if medical practitioners and private hospitals
become more and more commercialized, and if there is a corresponding increase in the
awareness of patient’s rights among the public, inevitably, a day may come when we may
have to move towards Canterbury. But not for the present.”59
Need of the Hour:

57
Supra n.52
 17

In India, the entire gamut of laws on consent turns into complex propositions if an
emergency medical situation arises. In a few of the milestone decisions, the apex court ruled
that a medical practitioner has a duty to treat a patient in an emergency. Emphasizing the
paramount duty of any “welfare state“, the Supreme Court stated that Art. 21 imposes an
obligation on the State to safeguard the right to life of every person .Indian position, although
we do not have much litigation, unlike in the West, it may be concluded that the courts have
assigned immense significance to the requirement of consent. A medical practitioner in India
has a duty to provide all the necessary information to the patient in a language that is
understandable to him. Regarding the quantum of information, there are no clear parameters
laid down by the courts. There is no mandate that a doctor should always obtain written
consent and failure of which would hold him liable. However, if there is written consent, the
medical practitioner would have greater ease in proving consent in case of litigation. To
standardize the practice, the Medical Council of India (MCI) has laid down guidelines that
are issued as regulations in which consent is required to be taken in writing before
performing an operation. The MCI guidelines are applicable to operations and do not cover
other treatments. For other treatments, the following may be noted as general guidelines:

1. For routine types of treatment, implied consent would suffice

2. For detailed types of treatment, ideally express oral consent may be needed
3. For complex types of treatment, written express consent is required

These statutory provisions do not provide clarity on whether a person between 12 and 18
years of age can give consent to undergo an invasive therapeutic procedure or investigation.
It is important to explicitly state whether a person of this age group can give consent
independently to undergo medical treatment or his/ her consent should be accompanied by
parental/guardian consent. In practice in the absence of clear-cut legal provisions most
doctors consider the consent of a person less than eighteen years sufficient for medical
examination only and for any other medical procedure ask for the consent of the parents

A professional is liable both under law of contract and tort. In general a professional man
owes to his client a duty in tort as well as in contract to exercise reasonable care in giving
advice or performing services. Liability in contract depends on the express or implied terms
agreed upon by the patient and the medical man. While tortious duties of professional man
are limited to taking reasonable care, the contractual duties are generally more onerous in
nature A contract is founded upon mutual consent and agreement. A tort is inflicted against
or without consent. A contract requires privity of parties. In tort no privity between parties is
needed. A tort is violation of right in rent, a right vested in some determinate person, either
personally or as a member of the community, and available against the world at large,
whereas a breach of a contract is an infringement to a right in personam, i.e. of a right
available only against some determinate person or body. In a breach of contract, the motive
for breach is immaterial while in a tort it is often taken into consideration. In a breach of
contract, damages are only compensation. Where the injury is caused to a person, character
or feelings and the facts disclosed improper motive or conduct which aggravates the

58
According to Canturbury v. Spence 1972 (464)Federal report 2d 772 it should be free from
imposition and it is a settled rule that a therapy not authorized by the patient shall amount to tort- a
common law battery .Thus a physician is bound tomake adequate disclosure to the patient.
59
Supra n.52
 18

plaintiffs injury, he may be awarded exemplary damages to punish the defendant and to deter
him in future in certain cases in tort but rarely in a contract. The same act may amount to a
tort and a breach of contract as well.
Tort is basically the origin of common law. Indian legal system has many similarities with
common law principles and thus courts in India have enough space for interpretation in that
line to hold a physician liable for medical negligence in those areas of medical practice
where Consumer Protection Act cannot address. Often they need the expert opinion of those
in medical field is required. The authenticity of the reports by persons who do not want to
defame their colleagues.
Under civil law, at a point where the Consumer Protection Act ends, the law of torts takes
over and protects the interests of patients. This applies even if medical professional provide
free service.60In cases where the services offered by the doctor or hospital do not fall in the
ambit of 'service' as defined in the consumer Protection Act, patients can take recourse to the
law relating to negligence under the law of torts and successfully claim compensation. The
onus is on the patient to prove that the doctor was negligent and that the injury was a
consequence of the doctor's negligence. Such cases of negligence may include transfusion of
blood of incorrect blood groups, leaving a mop in the patient's abdomen after operating,
unsuccessful sterilization resulting in the birth of a child, removal of organs without taking
consent, operating on a patient without giving anaesthesia, administering wrong medicine
resulting in injury, etc . All this highlights the need for specific legislation for age for giving
valid consent for medical procedures.

Remarkable developments in the field of medicine might have revolutionized health care.
But they cannot be afforded by the common man. The woes of non-affording patients have in
no way decreased. Gone are the days when any patient could go to a neighbourhood general
practitioner or a family doctor and get affordable treatment at a very reasonable cost, with
affection, care and concern. Their noble tribe is dwindling. Health care (like education) can
thrive in the hands of charitable institutions. It also requires more serious attention from the
State. In a developing country like India where teeming millions of poor, downtrodden and
illiterate cry out for health-care, there is a desperate need for making health-care easily
accessible and affordable. The private hospitals who think of increasing their profit, illegal
sale of organs for money, the section of parents ready to sell their children for the sake of
money., the mafia involved in trade of human organs etc all makes us think as to how to
tackle these problems. Consent promotes the rights of a patient as autonomous beings to
ensure that they are treated with justice, generosity, and respect. Neglecting its importance
can lead to unethical behaviour and the loss of patient’s rights.

Patients nowadays no longer want to be treated as passive recipients of medical care.

Medical litigation and demands for medical accountability is the trend of the day. To avoid
negligence and breaching, the doctor should exercise his skill with competence in accordance
with accepted practice. He should discuss his diagnosis and treatment plan with the patient. If
the patient inquires about the risks of proposed medical treatment, the doctor must disclose
the material risks to the patient. It is good practice to document contemporaneously his
advice to which the patient has consented. In doubt, it is prudent for the doctor to seek a
second opinion from his colleagues professing a similar skill. It can therefore be concluded
that Consent should be taken seriously by all clinicians and medical researchers in the
60
Talha Abdul Rahman, Medical negligence and doctor's liability, Indian J Med Ethics. 2005 Apr-Jun; 2(2)
 19

broader interest of patient-doctor relationship and there should be no compromise in

providing information that is not “reasonable” in the eyes of the court. In the event of an
adverse medical outcome written records of such discussions can be doctor’s best defence as
the court can demand relevant documents
SUGGESTIONS:
1. Fixing the age for giving consent.
2. Work on your rapport - The importance of good rapport between the patient and
doctor cannot be overemphasized. The level of rapport is a better predictor of the risk
of litigation than the actual content of any particular discussion
3. Discuss all treatment options with regardless of insurance coverage - Determining
what should be disclosed as a material risk in the consent process can be challenging.
4. By adopting paid insurance agents for guiding illiterate persons to take a decision
5. By using the ABCDEF mnemonic which is useful for guiding and documenting your
discussion with the patient:
• Alternative therapies available
• Benefits of the therapy proposed
• Common but not devastating risks  Devastating but not common risks
• Extra considerations specific to this patient
• Facial expressions, body language, and questions.
6. Decide how much medication information the patient needs
7. Discuss how test results will be communicated - Laboratory or radiology
investigations and their results introduce a unique set of issues. Particularly for non-
routine lab work, it is prudent to discuss the advantages, disadvantages, and
limitations of the test being ordered or recommended.
8. Keep a record of referrals - A patient generally has the right to refuse specialty
treatment or referral to a specialist, once informed of the risks of delay or lack of
treatment after making such a decision. If a patient still refuses referral, document the
decision in case it results in a delayed diagnosis or an adverse outcome.
9. Avoid making guarantees about procedure - All procedures, including associated
anesthesia, require a discussion of risks and benefits. If appropriate, also discuss
available alternative procedures and your reasons for not recommending them
10. Documentation is a necessary. It records the process that is vital to good patient care
and it may be the only proof that a discussion took place. Legal case opinions shed
little light on what represents adequate documentation.
11. Specific statute or guidelines that give a clear picture.
12. Special courts.

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