Dr Hitesh J.

Bhatt
M.D. (O&G) ; PGDMLS
Medico-legal consultant
Rainbow Women’s Hospital
1st Floor A wing
Swami Shivanand Society
Chakala Road
Nr Cigarette Factory
Andheri East
Mumbai 400099
Mob: 9833966522

We are living in the era of consumer awareness and evidence based practice. These
are two essential elements of any service based industry. Delivery of a health care is
no longer considered as a divine work and complications are not accepted as an ACT
OF GOD, rather the expectations for standard and safety from health care providers
are ranking among the tops in list.

The American examples inspired India as well and in case of Indian medical
association v. V.P. Shantha. (1995) 6 scc 651 The apex court gave decision that
patient is a consumer and health care providers can be sued for deficiencies in the
services in consumer courts. Though the result of the professional services are not
guaranteed and are dependent upon many factors which are beyond the control of
service providers, the Supreme Court held that the success or failure shall not be
made the subject of legal scrutiny but a minimum degree of professional skill and care
expected from an averagely skilled professional in discharge of his duty shall be
regulated.

The concept of the standard of care was further enhanced by the requirements of
documentations. Consent to the treatment forms an important medico-legal document.
Supreme Court of India in its landmark judgment of Sameera Kohli VS Dr Prabha
Manhanda elaborated its views on the topic of consent.

AGREEMENT AND CONTRACT

To understand this we must first understand Agreement and Contract. Agreement is

defined as “Every promise and every set of promises, forming the consideration for
each other, is an agreement”. Contract is an agreement enforceable by Law. So every
contract is an agreement but all agreements are not contract because every
agreement cannot be enforced by the law. For example if I promise my friend to attend
his birthday party ,this is an agreement but if I don’t reach for it no law can enforce any
penalty on me so this is not contract.
Further an agreement can become legally enforceable only when it fulfills following
criteria

1) Parties involved should be major ( More than 18 years of age)

2) It should be made by free consent
3) It should be for a lawful consideration and by lawful object. ( i.e. an agreement
to divide the profit earned from stealing things from store is not a contract
because the object “ stealing things” and consideration “ profit earned from the
sale from such things” are illegal in itself.

WHAT IS CONSENT?

 Consent is defined in Indian Contract Act – 1872 – Section-13.

“Two or more persons are said to consent, when they agree upon the
same thing in same sense”. i.e. “PARTIES AD IDEM”

For a consent to be valid; consent should not have been obtained by

 Coercion
 Undue influence
 Fraud
 Misrepresentation and
 Mistake – Of Fact and of Law

Who can give consent?

Both parties must be

 Major ( In our case doctor is always major)
Contracts by minor are void ab-initio (Dharmodas vs. Mohiribibi’s case)

 Mentally sound – Not insane or mentally retarded

Legal guardian should sign for minor or mentally ill patient

 Not under the effect of any intoxicated substance or anaesthesia

TYPES OF CONSENT

 Implied

Nothing is said or explained but both the parties understand the object.
eg. Patient coming to your chamber, it is implied that he/she has come
for examination and you can go ahead with history taking and
examination without any consent of your patient. Implied consent will
help you till examination of the patient, for any further investigations or
treatment informed consent is must

 Expressed / Informed– can be Oral or Written

But oral expressed consent has no legal value because it can’t be
proved when patient has already turned hostile.

Consent was better discussed in landmark judgment by Supreme Court,

  Samira Kohli vs. Dr. Prabha Manchanda & Anr.

(Appeal (civil) 1949 of 2004.; Date of judgment – 16/01/2008)

Bench - B.N. Agrawal, P.P. Naolekar & R.V. Raveendran (Judgment delivered by
Raveendran)

FACT OF THE CASE

• On 9/5/95 the appellant an unmarried lady aged 44 yrs visited the clinic of Dr.
Prabha Manchanda
• C/o Prolonged menstrual Bleeding for 9 days
• The doctor examined the patient and advised Ultrasound test on the same day.
• After examining the reports, the respondent had a discussion with the appellant
and advised her to come on the next day i.e. 10/05/1995 for a Laparoscopy test
under General Anaesthesia for making an affirmative diagnosis
• On 10/05/1995, the appellant went to the respondent’s clinic with her mother.
• On admission the appellant’s signature were taken on
1. Admission & Discharge Card
2. Consent form for hospital admission and medical treatment
3 Consent form for surgery reading as consent for “diagnostic and
operative laparoscopy. Laparotomy may be needed”

On diagnostic laparoscopy it appeared as a case of severe endometriosis and

Dr Prabha Manchanda performed total hysterectomy with bilateral salpingo
oophorectomy for curative treatment with the consent of patient’s mother as
patient was under anaesthesia. When Sameera Kohl challenged Dr Prabha
Manchanda at Supreme Court the Apex court summarized very important
principles related to consent. As follows:

(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 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.

But there is no need to explain remote or theoretical risks involved, which may
frighten or confuse a patient and result in refusal of consent for the necessary
treatment. Similarly, there is no need to explain the remote or theoretical risks
of refusal to take treatment which may persuade a patient to undergo a fanciful
or unnecessary treatment. A balance should be achieved between the need for
disclosing necessary and adequate information and at the same time avoid the
possibility of the patient being deterred from agreeing to a necessary treatment
or offering to undergo an unnecessary 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 defense 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.
(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 mentioned
in Canterbury 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.

After this landmark case on CONSENT, many cases were filed against doctors for
improper or absent consent and decided in favor of patient

(1) Mrs Zeba Hamid Vs Hajela Hospital and ors. (National Commission)
Jst Kulshreshta/Mrs Pramila S Kumar

o Primary infertility for diagnostic laparoscopy + Hysteroscopy

o Did Ovarian drilling and Salpingectomy without consent

Awarded : Rs 25,000/- + Rs 2000/-

(2) Mrs. Chandoke V Sir Ganga Ram hospital (National Commission)

o DUB with 2 previous LSCS for hysterecrtomy

o Consent was taken for abdominal hysterectomy (TAH)
o On table decided to operate through vaginal route (VH)
o Laparotomy because of bleeding from ovarian stump
o Needed nephrectomy (!!!)

Judgment
o Bleeding is no negligence
o Deviation from route consented is not acceptable ; unless it is life saving

Awarded : Rs. 500,000/- ( Five lacs)

(3) Mr. C. Jayapal Reddy V/S Yashoda Group of Hospitals (National

Commission)
 o The patient, Kusuma had complaints of abdominal pain and menstrual
disturbances and other complaints for more than one year.
o She was diagnosed as C/O of fibroid uterus & Endometriosis.
o She was advised treatment of Tab. Danogen -50 mg etc
o Advised total abdominal Hysterectomy and It was done without any
complication
o The complainant contended that the operation was conducted on his
wife, without the valid consent of his wife or himself.
o Hospital took his signatures on the blank form. (this is not valid consent)
o The complainant had only one child and he said they wanted to have a
second child .Now it will be possible by IVF or test tube baby method
with surrogate mother, again as his wife lost her ovaries after operation,
he had to search for an ovum donor and incur heavy expenditure

Compensation demanded was:

Rs. 1,25,00,000/- (one crore twenty five lacs) and for pain and
suffering Rs. 25,00,000 (twenty five lacs)

Awarded : Rs.10,00,000/- ( ten lacs) with 9% interest

There is an Indian Medical Council Act; 1956 for the consent (Section – 33 clause 13)

• Before performing an operation the physician should obtain in writing the

consent from the husband or wife, parent or guardian in the case of
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.

There are certain Acts which includes consent as an annexure of the act itself and in
such case one must take consent on that particular form and not on any other consent
form. PCPNDT ACT (Form G ); MTP ACT (Form C) etc.

Consent in IPC

 Chapter of General Exceptions Section 87 to 92 of IPC deals with the Consent

 Act not intended to cause grievous hurt-87 or death-88 done with consent in
good faith for person’s benefit

Section 88. (IPC)

“Nothing, which is not intended to cause death, is an offence by reason of any harm
which it may cause, or be intended by the doer to cause, or be known by the doer to
be likely to cause, to any person for whose benefit it is done in good faith, and who
has given a consent, whether express or implied to suffer that harm, or to take the risk
of that harm.”

Negative Consent:

When patient is not ready to take the treatment offered by you, please take negative
consent of the patient for the same and if patient do not sign it then get it signed by
the witness eg. other patient or relatives of some patient. This will help you in saving
yourself in case of litigation by proving contributory negligence of the patient.

At the end, looking at the legal expectations for the consent, there is a serious
need to develop standard consents for various common operations. Just few common
lines written as a consent for surgery has stopped standing the test of law after the
landmark judgment. So give as much importance to documentation as you give to the
surgery or treatment itself because in the eyes of law “the thing which is not
documented never happened”.

Further Reading:

(1) Charles C, Gafni A, Whelan T (1997). Shared decision-making in the medical

encounter: what does it mean? (or it takes at least two to tango). Social Science
and Medicine 44(5):681-92.
(2) Delany C (2005). Respecting patient autonomy and obtaining their informed
consent: ethical theory - missing in action.
(3) Sim J (1997). Ethical decision-making in therapy practice. Oxford, Reed, pp 59-75,
(chapter 4).
(4) Appelbaum PS, Lidz CW, Meisel A (1987). Informed Consent: Legal theory and
clinical practice. Oxford University Press, New York.
(5) 9.0 9.1 Wear S (1998). Informed consent: Patient autonomy and clinician
beneficence within healthcare. Second edition. Georgetown University Press.
Washinton, DC.
(6) Jensen AB (1990). Informed consent. Historical perspective and current problems.
Ugeskr Laeger, Nov 26;152(48):3591-3.