Supreme Court: Patient’s consent must for surgical interventions

CASE NO.:
Appeal (civil) 1949 of 2004

PETITIONER:
Samira Kohli

RESPONDENT:
Dr. Prabha Manchanda & Anr.

DATE OF JUDGMENT: 16/01/2008

BENCH:
B. N. Agarwal, P. P. Naolekar & R. V. Raveendran

JUDGMENT:
J U D G M E N T


RAVEENDRAN, J.


This appeal is filed against the order dated 19.11.2003 passed by
the National Consumer Disputes Redressal Commission (for short
'Commission') rejecting the appellants complaint (O.P. No.12/1996)
under Section 21 of the Consumer Protection Act, 1986 (Act for short).

Undisputed facts

2. On 9.5.1995, the appellant, an unmarried woman aged 44 years,
visited the clinic of the first respondent (for short the respondent)
complaining of prolonged menstrual bleeding for nine days. The
respondent examined and advised her to undergo an ultrasound test on the
same day. After examining the report, the respondent had a discussion
with appellant and advised her to come on the next day (10.5.1995) for a
laparoscopy test under general anesthesia, for making an affirmative
diagnosis.

3. Accordingly, on 10.5.1995, the appellant went to the respondent's
clinic with her mother. On admission, the appellant's signatures were
taken on (i) admission and discharge card; (ii) consent form for hospital
admission and medical treatment; and (iii) consent form for surgery. The
Admission Card showed that admission was for diagnostic and operative
laparoscopy on 10.5.1995". The consent form for surgery filled by Dr.
Lata Rangan (respondent's assistant) described the procedure to be
undergone by the appellant as "diagnostic and operative laparoscopy.
Laparotomy may be needed". Thereafter, appellant was put under general
anesthesia and subjected to a laparoscopic examination. When the
appellant was still unconscious, Dr. Lata Rengen, who was assisting the
respondent, came out of the Operation Theatre and took the consent of
appellants mother, who was waiting outside, for performing
hysterectomy under general anesthesia. Thereafter, the Respondent
performed a abdominal hystecrectomy (removal of uterus) and bilateral
salpingo-oopherectomy (removal of ovaries and fallopian tubes). The
appellant left the respondents clinic on 15.5.1995 without settling the
bill.

4. On 23.5.1995, the respondent lodged a complaint with the Police
alleging that on 15.5.1995, the Appellant's friend (Commander Zutshi)
had abused and threatened her (respondent) and that against medical
advice, he got the appellant discharged without clearing the bill. The
appellant also lodged a complaint against the respondent on 31.5.1995,
alleging negligence and unauthorized removal of her reproductive organs.
The first respondent issued a legal notice dated 5.6.1995 demanding
Rs.39,325/- for professional services. The appellant sent a reply dated
12.7.1995. There was a rejoinder dated 18.7.1995 from the respondent
and a further reply dated 11.9.1995 from the appellant. On 19.1.1996 the
appellant filed a complaint before the Commission claiming a
compensation of Rs.25 lakhs from the Respondent. The appellant alleged
that respondent was negligent in treating her; that the radical surgery by
which her uterus, ovaries and fallopian tubes were removed without her
consent, when she was under general anesthesia for a Laparascopic test,
was unlawful, unauthorized and unwarranted; that on account of the
removal of her reproductive organs, she had suffered premature
menopause necessitating a prolonged medical treatment and a Harmone
Replacement Therapy (HRT) course, apart from making her vulnerable to
health problems by way of side effects. The compensation claimed was
for the loss of reproductive organs and consequential loss of opportunity
to become a mother, for diminished matrimonial prospects, for physical
injury resulting in the loss of vital body organs and irreversible
permanent damage, for pain, suffering emotional stress and trauma, and
for decline in the health and increasing vulnerability to health hazards.

5. During the pendency of the complaint, at the instance of the
respondent, her insurer - New India Assurance Co. Ltd, was impleaded as
the second respondent. Parties led evidence - both oral and documentary,
Appellant examined an expert witness (Dr. Puneet Bedi, Obstetrician &
Gynaecologist), her mother (Sumi Kohli) and herself. The respondent
examined herself, an expert witness (Dr. Sudha Salhan, Professor of
Obstetrics & Gynaecology and President of Association of Obstetricians
and Gynaecologists of Delhi), Dr. Latha Rangan (Doctor who assisted the
Respondent) and Dr. Shiela Mehra (Anaesthetist for the surgery). The
medical records and notices exchanged were produced as evidence. After
hearing arguments, the Commission dismissed the complaint by order
dated 19.11.2003. The Commission held : (a) the appellant voluntarily
visited the respondents clinic for treatment and consented for diagnostic
procedures and operative surgery; (ii) the hysterectomy and other surgical
procedures were done with adequate care and caution; and (iii) the
surgical removal of uterus, ovaries etc. was necessitated as the appellant
was found to be suffering from endometriosis (Grade IV), and if they had
not been removed, there was likelihood of the lesion extending to the
intestines and bladder and damaging them. Feeling aggrieved, the
appellant has filed this appeal.

The appellants version :



6. The appellant consulted respondent on 9.5.1995. Respondent
wanted an ultra-sound test to be done on the same day. In the evening,
after seeing the ultrasound report, the respondent informed her that she
was suffering from fibroids and that to make a firm diagnosis, she had to
undergo a laparoscopic test the next day. The respondent informed her
that the test was a minor procedure involving a small puncture for
examination under general anesthesia. The respondent informed her that
the costs of laparoscopic test, hospitalization, and anesthetists charges
would be around Rs.8000 to 9,000. Respondent spent hardly 4 to 5
minutes with her and there was no discussion about the nature of
treatment. Respondent merely told her that she will discuss the line of
treatment, after the laparoscopic test. On 10.5.1995, she went to the clinic
only for a diagnostic laparoscopy. Her signature was taken on some blank
printed forms without giving her an opportunity to read the contents. As
only a diagnostic procedure by way of a laparoscopic test was to be
conducted, there was no discussion, even on 10.5.1995, with regard to
any proposed treatment. As she was intending to marry within a month
and start a family, she would have refused consent for removal of her
reproductive organs and would have opted for conservative treatment,
had she been informed about any proposed surgery for removal of her
reproductive organs.

7. When the appellant was under general anaesthesia, respondent
rushed out of the operation theatre and told appellant's mother that she
had started bleeding profusely and gave an impression that the only way
to save her life was by performing an extensive surgery. Appellant's aged
mother was made to believe that there was a life threatening situation,
and her signature was taken to some paper. Respondent did not choose to
wait till appellant regained consciousness, to discuss about the findings of
the laparoscopic test and take her consent for treatment. The appellant
was kept in the dark about the radical surgery performed on her. She
came to know about it, only on 14.5.1995 when respondents son casually
informed her about the removal of her reproductive organs. When she
asked the respondent as to why there should be profuse bleeding during a
Laparoscopic test (as informed to appellant's mother) and why her
reproductive organs were removed in such haste without informing her,
without her consent, and without affording her an opportunity to consider
other options or seek other opinion, the respondent answered rudely that
due to her age, conception was not possible, and therefore, the removal of
her reproductive organs did not make any difference.

8. As she was admitted only for a diagnostic procedure, namely a
laparoscopy test, and as she had given consent only for a laparoscopy test
and as her mothers consent for conducting hysterectomy had been
obtained by misrepresentation, there was no valid consent for the radical
surgery. The respondent also tried to cover up her unwarranted/negligent
act by falsely alleging that the appellant was suffering from
endometriosis. The respondent was guilty of two distinct acts of
negligence: the first was the failure to take her consent, much less an
informed consent, for the radical surgery involving removal of
reproductive organs; and the second was the failure to exhaust
conservative treatment before resorting to radical surgery, particularly
when such drastic irreversible surgical procedure was not warranted in
her case. The respondent did not inform the appellant, of the possible
risks, side effects and complications associated with such surgery, before
undertaking the surgical procedure. Such surgery without her consent was
also in violation of medical Rules and ethics. Removal of her
reproductive organs also resulted in a severe physical impairment, and
necessitated prolonged further treatment. The respondent was also not
qualified to claim to be a specialist in Obstetrics and Gynaecology and
therefore could not have performed the surgery which only a qualified
Gynaecologist could perform.


The respondents version


9. The appellant had an emergency consultation with the respondent
on 9.5.1995, complaining that she had heavy vaginal bleeding from
30.4.1995, that her periods were irregular, and that she was suffering
from excessive, irregular and painful menstruation (menorrhagia and
dysmenorrhea) for a few months. On a clinical examination, the
respondent found a huge mass in the pelvic region and tenderness in the
whole area. In view of the severe condition, Respondent advised an
ultrasound examination on the same evening. Such examination showed
fibroids in the uterus, a large chocolate cyst (also known as endometrical
cyst) on the right side and small cysts on the left side. On the basis of
clinical and ultra sound examination, she made a provisional diagnosis of
endometriosis and informed the appellant about the nature of the ailment,
the anticipated extent of severity, and the modality of treatment. She
further informed the appellant that a laparoscopic examination was
needed to confirm the diagnosis; that if on such examination, she found
that the condition was manageable with conservative surgery, she would
only remove the chocolate cyst and fulgurate the endometric areas and
follow it by medical therapy; and that if the lesion was extensive, then
considering her age and likelihood of destruction of the function of the
tubes, she will perform hysterectomy. She also explained the surgical
procedure involved, and answered appellant's queries. The appellant
stated that she was in acute discomfort and wanted a permanent cure and,
therefore whatever was considered necessary, including a hysterectomy
may be performed. When appellants mother called on her on the same
evening, the respondent explained to her also about the nature of disease
and the proposed treatment, and appellant's mother stated that she may do
whatever was best for her daughter. According to the accepted medical
practice, if endometriosis is widespread in the pelvis causing adhesions,
and if the woman is over 40 years of age, the best and safest form of cure
was to remove the uterus and the ovaries. As there is a decline in
fecundity for most women in the fourth decade and a further decline in
women in their forties, hysterectomy is always considered as a reasonable
and favoured option. Further, endometriosis itself affected fertility
adversely. All these were made known to the appellant before she
authorised the removal of uterus and ovaries, if found necessary on
laparoscopic examination.

10. On 10.5.1995, the appellants consent was formally recorded in the
consent form by Dr. Lata Rangan - respondent's assistant. Dr. Lata
Rangan informed the appellant about the consequences of such consent
and explained the procedure that was proposed. The appellant signed the
consent forms only after she read the duly filled up forms and understood
their contents. All the requisite tests to be conducted mandatorily before
the surgery were performed including Blood Grouping, HIV,
Hemoglobin, PCV, BT, CT and ECG. The laparoscopic examination of
the uterus surface confirmed the provisional diagnosis of endometriosis.
The right ovary was enlarged and showed a chocolate cyst stuck to the
bowel. Right tube was also involved in the lesion. The left ovary and tube
were also stuck to the bowel near the cervix. A few small cysts were seen
on the left ovary. The pelvic organs were thick and difficult to mobilize.
Having regard to the extent of the lesion and the condition of appellant's
uterus and ovaries, she decided that conservative surgery would not be
sufficient and the appellants problem required removal of uterus and
ovaries. The respondent sent her assistant, Dr. Lata Rangan to explain to
appellants mother that the lesion would not respond to conservative
surgery and a hysterectomy had to be performed and took her consent.
The surgery was extremely difficult due to adhesions and vascularity of
surface. A sub-total hysterectomy was done followed by the removal of
rest of the stump of cervix. As the right ovary was completely stuck
down to bowel, pouch of douglas, post surface and tube, it had to be
removed piecemeal. When appellant regained consciousness, she was
informed about the surgery. The appellant felt assured that heavy
bleeding and pain would not recur. There was no protest either from the
appellant or her mother, in regard to the removal of the ovaries and
uterus.

11. However, on 15.5.1995, Commander Zutshi to whom appellant
was said to have been engaged, created a scene and got her discharged.
At the time of discharge, the summary of procedure and prescription of
medicines were given to her. As the bill was not paid, the respondent
filed Suit No.469/1995 for recovery of the bill amount and the said suit
was decreed in due course.

12. Respondent performed the proper surgical procedure in pursuance
of the consent given by the appellant and there was no negligence,
illegality, impropriety or professional misconduct. There was real and
informed consent by the appellant for the removal of her reproductive
organs. The surgery (removal of uterus and ovaries), not only cured the
appellant of her disease but also saved her intestines, bladder and ureter
from possible damage. But for the surgical removal, there was likelihood
of the intestines being damaged due to extension of lesion thereby
causing bleeding, fibrosis and narrowing of the gut; there was also
likelihood of the lesion going to the surface of the bladder penetrating the
wall and causing haematuria and the ureter being damaged due to fibrosis
and leading to damage of the kidney, with a reasonable real chance of
developing cancer. As the complainant was already on the wrong side of
40 years which is a peri-menopausal age and as the appellant had
menorrhagia which prevented her from ovulating regularly and giving her
regular cycle necessary for pregnancy and as endometriosis prevented
fertilization and also produced reaction in the pelvis which increased the
lymphocytes and macrophages which destroyed the ova and sperm, there
was no chance of appellant conceiving, even if the surgery had not been
performed. The removal of her uterus and ovaries was proper and
necessary and there was no negligence on the part of the respondent in
performing the surgery. A Doctor who has acted in accordance with a
practice accepted as proper by medical fraternity cannot be said to have
acted negligently. In the realm of diagnosis and treatment there is ample
scope for genuine differences of opinion and no Doctor can be said to
have acted negligently merely because his or her opinion differs from that
of other Doctors or because he or she has displayed lesser skill or
knowledge when compared to others. There was thus no negligence on
her part.

Questions for consideration :

13. On the contentions raised, the following questions arise for our
consideration :
(i) Whether informed consent of a patient is necessary for surgical
procedure involving removal of reproductive organs? If so what is
the nature of such consent ?

(ii) When a patient consults a medical practitioner, whether consent
given for diagnostic surgery, can be construed as consent for
performing additional or further surgical procedure -- either as
conservative treatment or as radical treatment -- without the
specific consent for such additional or further surgery.

(iii) Whether there was consent by the appellant, for the abdominal
hysterectomy and Bilateral Salpingo-oopherectomy (for short AH-
BSO) performed by the respondent?

(iv) Whether the respondent had falsely invented a case that appellant
was suffering from endometriosis to explain the unauthorized and
unwarranted removal of uterus and ovaries, and whether such
radical surgery was either to cover-up negligence in conducting
diagnostic laparoscopy or to claim a higher fee ?

(v) Even if appellant was suffering from endometriosis, the respondent
ought to have resorted to conservative treatment/surgery instead of
performing radical surgery ?

(vi) Whether the Respondent is guilty of the tortious act of
negligence/battery amounting to deficiency in service, and
consequently liable to pay damages to the appellant.

Re : Question No.(i) and (ii)

14. Consent in the context of a doctor-patient relationship, means the
grant of permission by the patient for an act to be carried out by the
doctor, such as a diagnostic, surgical or therapeutic procedure. Consent
can be implied in some circumstances from the action of the patient. For
example, when a patient enters a Dentist's clinic and sits in the Dental
chair, his consent is implied for examination, diagnosis and consultation.
Except where consent can be clearly and obviously implied, there should
be express consent. There is, however, a significant difference in the
nature of express consent of the patient, known as 'real consent' in UK
and as 'informed consent' in America. In UK, the elements of consent are
defined with reference to the patient and a consent is considered to be
valid and 'real' when (i) the patient gives it voluntarily without any
coercion; (ii) the patient has the capacity and competence to give consent;
and (iii) the patient has the minimum of adequate level of information
about the nature of the procedure to which he is consenting to. On the
other hand, the concept of 'informed consent' developed by American
courts, while retaining the basic requirements consent, shifts the emphasis
to the doctor's duty to disclose the necessary information to the patient to
secure his consent. 'Informed consent' is defined in Taber's Cyclopedic
Medical Dictionary thus :

"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."

In Canterbury v. Spence - 1972 [464] Federal Reporter 2d. 772, the
United States Courts of appeals, District of Columbia Circuit, emphasized
the element of Doctor's duty in 'informed consent' thus:
"It is well established that the physician must seek and secure his
patient's consent before commencing an operation or other course of
treatment. It is also clear that the consent, to be efficacious, must be
free from imposition upon the patient. It is the settled rule that therapy
not authorized by the patient may amount to a tort - a common law
battery - by the physician. And it is evident that it is normally
impossible to obtain a consent worthy of the name unless the physician
first elucidates the options and the perils for the patient's edification.
Thus the physician has long borne a duty, on pain of liability for
unauthorized treatment, to make adequate disclosure to the patient."

[Emphasis supplied]

15. The basic principle in regard to patient's consent may be traced to
the following classic statement by Justice Cardozo in Schoendorff vs.
Society of New York Hospital - (1914) 211 NY 125 :
'Every human being of adult years and sound mind has a right
to determine what should be done with his body; and a surgeon
who performs the operation without his patient's consent,
commits an assault for which he is liable in damages."

This principle has been accepted by English court also. In Re : F. 1989(2)
All ER 545, the House of Lords while dealing with a case of sterilization
of a mental patient reiterated the fundamental principle that every
person's body is inviolate and performance of a medical operation on a
person without his or her consent is unlawful. The English law on this
aspect is summarised thus in Principles of Medical Law (published by
Oxford University Press -- Second Edition, edited by Andrew Grubb,
Para 3.04, Page 133) :
"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."



16. The next question is whether 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 operative procedures performed in
the interests of the patient. In Murray vs. McMurchy - 1949 (2) DLR 442,
the Supreme Court of BC, Canada, was considering a claim for battery by
a patient who underwent a caesarian section. During the course of
caesarian section, the doctor found fibroid tumors in the patient's uterus.
Being of the view that such tumours would be a danger in case of future
pregnancy, he performed a sterilization operation. The court upheld the
claim for damages for battery. It held that sterilization could not be
justified under the principle of necessity, as there was no immediate
threat or danger to the patient's health or life and it would not have been
unreasonable to postpone the operation to secure the patient's consent.
The fact that the doctor found it convenient to perform the sterilization
operation without consent as the patient was already under general
anaesthetic, was held to be not a valid defence. A somewhat similar view
was expressed by Courts of Appeal in England in Re : F. (supra). It was
held that the additional or further treatment which can be given (outside
the consented procedure) should be confined to only such treatment as is
necessary to meet the emergency, and as such needs to be carried out at
once and before the patient is likely to be in a position to make a decision
for himself. Lord Goff observed :

"Where, for example, a surgeon performs an operation without
his consent on a patient temporarily rendered unconscious in an
accident, he should do no more than is reasonably required, in
the best interests of the patient, before he recovers
consciousness. I can see no practical difficulty arising from this
requirement, which derives from the fact that the patient is
expected before long to regain consciousness and can then be
consulted about longer term measures."

The decision in Marshell vs. Curry - 1933 (3) DLR 260 decided by the
Supreme Court of NS, Canada, illustrates the exception to the rule, that
an unauthorized procedure may be justified if the patient's medical
condition brooks no delay and warrants immediate action without
waiting for the patient to regain consciousness and take a decision for
himself. In that case the doctor discovered a grossly diseased testicle
while performing a hernia operation. As the doctor considered it to be
gangrenous, posing a threat to patient's life and health, the doctor
removed it without consent, as a part of the hernia operation. An action
for battery was brought on the ground that the consent was for a hernia
operation and removal of testicle was not consent. The claim was
dismissed. The court was of the view that the doctor can act without the
consent of the patient where it is necessary to save the life or preserve the
health of the patient. Thus, the principle of necessity by which the doctor
is permitted to perform further or additional procedure (unauthorized) is
restricted to cases where the patient is temporarily incompetent (being
unconscious), to permit the procedure delaying of which would be
unreasonable because of the imminent danger to the life or health of the
patient.

17. It is quite possible that if the patient been conscious, and informed
about the need for the additional procedure, the patient might have agreed
to it. It may be that the additional procedure is beneficial and in the
interests of the patient. It may be that postponement of the additional
procedure (say removal of an organ) may require another surgery,
whereas removal of the affected organ during the initial diagnostic or
exploratory surgery, would save the patient from the pain and cost of a
second operation. Howsoever practical or convenient the reasons may be,
they are not relevant. What is relevant and of importance is 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.
Therefore at the risk of repetition, we may add that unless the
unauthorized additional or further procedure is necessary in order to save
the life or preserve the health of the patient and it would be unreasonable
(as contrasted from being merely inconvenient) to delay the further
procedure until the patient regains consciousness and takes a decision, a
doctor cannot perform such procedure without the consent of the patient.

18. We may also refer to the code of medical ethics laid down by the
Medical Council of India (approved by the Central Government under
section 33 of Indian Medical Council Act, 1956). It 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 places the following responsibility on a doctor :

"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 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."

We may also refer to the following guidelines to doctors, issued by the
General Medical Council of U.K. in seeking consent of the patient for
investigation and treatment :

"Patients have a right to information about their condition and the
treatment options available to them. The amount of information you
give each patient will vary, according to factors such as the nature of
the condition, the complexity of the treatment, the risks associated with
the treatment or procedure, and the patient's own wishes. For example,
patients may need more information to make an informed decision
about the procedure which carries a high risk of failure or adverse side
effects; or about an investigation for a condition which, if present,
could have serious implications for the patient's employment, social or
personal life.

x x x x x

You should raise with patients the possibility of additional problems
coming to light during a procedure when the patient is unconscious or
otherwise unable to make a decision. You should seek consent to treat
any problems which you think may arise and ascertain whether there
are any procedures to which the patient would object, or prefer to give
further thought before you proceed."


The Consent form for Hospital admission and medical treatment, to
which appellant's signature was obtained by the respondent on 10.5.1995,
which can safely be presumed to constitute the contract between the
parties, specifically states :
"(A) It is customary, except in emergency or extraordinary
circumstances, that no substantial procedures are performed upon a
patient unless and until he or she has had an opportunity to discuss
them with the physician or other health professional to the patient's
satisfaction.

(B) Each patient has right to consent, or to refuse consent, to any
proposed procedure of therapeutic course."


19. We therefore hold that in Medical Law, where a surgeon is
consulted by a patient, and consent of the patient is taken for diagnostic
procedure/surgery, such consent cannot be considered as authorisation or
permission to perform therapeutic surgery either conservative or radical
(except in life threatening or emergent situations). Similarly where the
consent by the patient is for a particular operative surgery, it cannot be
treated as consent for an unauthorized additional procedure involving
removal of an organ, only on the ground that such removal is beneficial to
the patient or is likely to prevent some danger developing in future, where
there is no imminent danger to the life or health of the patient.

20. We may next consider the nature of information that is required to
be furnished by a Doctor to secure a valid or real consent. In Bowater v.
Rowley Regis Corporation - [1944] 1 KB 476, Scott L.J. observed :
"A man cannot be said to be truly 'willing' unless he is in a
position to choose freely, and freedom of choice predicates, not
only full knowledge of the circumstances on which the exercise
of choice is conditioned, so that he may be able to choose
wisely, but the absence from his mind of any feeling of
constraint so that nothing shall interfere with the freedom of his
will."


In Salgo vs. Leland Stanford [154 Cal. App. 2d.560 (1957)], it was held
that a physician violates his duty to his patient and subjects himself to
liability if he withholds any facts which are necessary to form the basis of
an intelligent consent by the patient to the proposed treatment.

21. Canterbury (supra) explored the rationale of a Doctor's duty to
reasonably inform a patient as to the treatment alternatives available and
the risk incidental to them, as also the scope of the disclosure requirement
and the physician's privileges not to disclose. It laid down the 'reasonably
prudent patient test' which required the doctor to disclose all material
risks to a patient, to show an 'informed consent'. It was held :
"True consent to what happens to one's self is the informed exercise of
a choice, and that entails an opportunity to evaluate knowledgeably the
options available and the risks attendant upon each. The average
patient has little or no understanding of the medical arts, and ordinarily
has only his physician to whom he can look for enlightenment with
which to reach an intelligent decision. From these almost axiomatic
considerations springs the need, and in turn the requirement, of a
reasonable divulgence by physician to patient to make such a decision
possible.

Just as plainly, due care normally demands that the physician warn
the patient of any risks to his well being which contemplated therapy
may involve.

The context in which the duty of risk-disclosure arises is invariably the
occasion for decision as to whether a particular treatment procedure is
to be undertaken. To the physician, whose training enables a self-
satisfying evaluation, the answer may seem clear, but it is the
prerogative of the patient, not the physician, to determine for himself
the direction in which his interests seem to lie. To enable the patient to
chart his course understandably, some familiarity with the therapeutic
alternatives and their hazards becomes essential

A reasonable revelation in these respects is not only a necessity but, as
we see it, is as much 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. It is, too, a duty to impart information which
the patient has every right to expect. 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 terms of contemplated treatment, is well-nigh abject. we
ourselves have found "in the fiducial qualities of (the physician-
patient) relationship the physician's duty to reveal to the patient that
which in his best interests it is important that he should know." We
now find, as a part of the physician's overall obligation to the patient, a
similar duty of reasonable disclosure of the choices with respect to
proposed therapy and the dangers inherently and potentially involve.


In our view, 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 its materially to the patient's
decision : all risks potentially affecting the decision must be unmasked.
"


It was further held that a risk is material 'when a reasonable person, in
what the physician knows or should know to be the patient's position,
would be likely to attach significance to the risk or cluster of risks in
deciding whether or not to forego the proposed therapy'. The doctor,
therefore, is required to communicate all inherent and potential hazards of
the proposed treatment, the alternatives to that treatment, if any, and the
likely effect if the patient remained untreated. This stringent standard of
disclosure was subjected to only two exceptions : (i) where there was a
genuine emergency, e.g. the patient was unconscious; and (ii) where the
information would be harmful to the patient, e.g. where it might cause
psychological damage, or where the patient would become so emotionally
distraught as to prevent a rational decision. It, however, appears that
several States in USA have chosen to avoid the decision in Canterbury by
enacting legislation which severely curtails operation of the doctrine of
informed consent.
22. The stringent standards regarding disclosure laid down in
Canterbury, as necessary to secure an informed consent of the patient,
was not accepted in the English courts. In England, standard applicable is
popularly known as the Bolam Test, first laid down in Bolam v. Friern
Hospital Management Committee - [1957] 2 All.E.R. 118. McNair J., in a
trial relating to negligence of a medical practitioner, while instructing the
Jury, stated thus :

"(i) A doctor is not negligent, if he has acted in accordance with a
practice accepted as proper by a responsible body of medical men
skilled in that particular art.  Putting it the other way round, a
doctor is not negligent, if he is acting in accordance with such a
practice, merely because there is a body of opinion that takes a
contrary view. At the same time, that does not mean that a medical
man can obstinately and pig-headedly carry on with some old
technique if it has been proved to be contrary to what is really
substantially the whole of informed medical opinion.

(ii) When a doctor dealing with a sick man strongly believed that
the only hope of cure was submission to a particular therapy, he could
not be criticized if, believing the danger involved in the treatment to be
minimal, did not stress them to the patient.

(iii) In order to recover damages for failure to give warning the
plaintiff must show not only that the failure was negligent but also that
if he had been warned he would not have consented to the treatment.

23. Hunter v. Hanley (1955 SC 200), a Scottish case is also worth
noticing. In that decision, Lord President Clyde held :
"In the realm of diagnosis and treatment there is ample scope for genuine
difference of opinion and one man clearly is not negligent merely
because his conclusion differs from that of other professional men, nor
because he has displayed less skill or knowledge than others would have
shown. The true test for establishing negligence in diagnosis or treatment
on the part of a doctor is whether he has been proved to be guilty of such
failure as no doctor of ordinary skill would be guilty of if acting with
ordinary care."


He also laid down the following requirements to be established by a
patient to fasten liability on the ground of want of care or negligence on
the part of the doctor :
"To establish liability by a doctor where deviation from normal practice
is alleged, three facts require to be established. First of all it must be
proved that there is a usual and normal practice; secondly it must be
proved that the defender has not adopted that practice; and thirdly (and
this is of crucial importance) it must be established that the course the
doctor adopted is one which no professional man of ordinary skill would
have taken if he had been acting with ordinary care."


24. In Sidaway v. Bethlem Royal Hospital Governors & Ors. [1985] 1
All ER 643, the House of Lords, per majority, adopted the Bolam test, as
the measure of doctor's duty to disclose information about the potential
consequences and risks of proposed medical treatment. In that case the
defendant, a surgeon, warned the plaintiff of the possibility of disturbing
a nerve root while advising an operation on the spinal column to relieve
shoulder and neck pain. He did not however mention the possibility of
damage to the spinal cord. Though the operation was performed without
negligence, the plaintiff sustained damage to spinal cord resulting in
partial paralysis. The plaintiff alleged that defendant was negligent in
failing to inform her about the said risk and that had she known the true
position, she would not have accepted the treatment. The trial Judge and
Court of Appeal applied the Bolam test and concluded that the defendant
had acted in accordance with a practice accepted as proper by a
responsible body of medical opinion, in not informing the plaintiff of the
risk of damage to spinal cord. Consequently, the claim for damages was
rejected. The House of Lords upheld the decision of the Court of Appeal
that the doctrine of informed consent based on full disclosure of all the
facts to the patient, was not the appropriate test of liability for negligence,
under English law. The majority were of the view that the test of liability
in respect of a doctor's duty to warn his patient of risks inherent in
treatment recommended by him was the same as the test applicable to
diagnosis and treatment, namely, that the doctor was required to act in
accordance with the practice accepted at the time as proper by a
responsible body of medical opinion. Lord Diplock stated:
"In English jurisprudence the doctor's relationship with his patient
which gives rise to the normal duty of care to exercise his skill and
judgment to improve the patient's health in any particular respect in
which the patient has sought his aid has hitherto been treated as a
single comprehensive duty covering all the ways in which a doctor is
called on to exercise his skill and judgment in the improvement of the
physical or mental condition of the patient for which his services either
as a general practitioner or as a specialist have been engaged. This
general duty is not subject to dissection into a number of component
parts to which different criteria of what satisfy the duty of care apply,
such as diagnosis, treatment and advice (including warning of any risks
of something going wrong however skillfully the treatment advised is
carried out). The Bolam case itself embraced failure to advise the
patient of the risk involved in the electric shock treatment as one of the
allegations of negligence against the surgeon as well as negligence in
the actual carrying out of treatment in which that risk did result in
injury to the patient. The same criteria were applied to both these
aspects of the surgeon's duty of care. In modern medicine and surgery
such dissection of the various things a doctor has to do in the exercise
of his whole duty of care owed to his patient is neither legally
meaningful nor medically practicable. To decide what risks the
existence of which a patient should be voluntarily warned and the
terms in which such warning, if any, should be given, having regard to
the effect that the warning may have, is as much an exercise of
professional skill and judgment as any other part of the doctor's
comprehensive duty of care to the individual patient, and expert
medical evidence on this matter should be treated in just the same way.
The Bolam test should be applied."

Lord Bridge stated :

"I recognize the logical force of the Canterbury doctrine, proceeding
from the premise that the patient's right to make his own decision must
at all costs be safeguarded against the kind of medical paternalism
which assumes that 'doctor knows best'. But, with all respect, I regard
the doctrine as quite impractical in application for three principal
reasons. First, it gives insufficient weight to the realities of the
doctor/patient relationship. A very wide variety of factors must enter
into a doctor's clinical judgment not only as to what treatment is
appropriate for a particular patient, but also as to how best to
communicate to the patient the significant factors necessary to enable
the patient to make an informed decision whether to undergo the
treatment. The doctor cannot set out to educate the patient to his own
standard of medical knowledge of all the relevant factors involved. He
may take the view, certainly with some patients, that the very fact of
his volunteering, without being asked, information of some remote risk
involved in the treatment proposed, even though he described it as
remote, may lead to that risk assuming an undue significance in the
patient's calculations. Second, it would seem to me quite unrealistic in
any medical negligence action to confine the expert medical evidence
to an explanation of the primary medical factors involved and to deny
the court the benefit of evidence of medical opinion and practice on the
particular issue of disclosure which is under consideration. Third, the
objective test which Canterbury propounds seems to me to be so
imprecise as to be almost meaningless. If it is to be left to individual
judges to decide for themselves what "a reasonable person in the
patient's position' would consider a risk of sufficient significance that
he should be told about it, the outcome of litigation in this field is
likely to be quite unpredictable."


Lord Bridge however made it clear that when questioned specifically by
the patient about the risks involved in a particular treatment proposed, the
doctor's duty is to answer truthfully and as fully as the questioner
requires. He further held that remote risk of damage (referred to as risk at
1 or 2%) need not be disclosed but if the risk of damage is substantial
(referred to as 10% risk), it may have to be disclosed. Lord Scarman, in
minority, was inclined to adopt the more stringent test laid down in
Canterbury.

25. In India, Bolam test has broadly been accepted as the general rule.
We may refer three cases of this Court. In Achutrao Haribhau Khodwa
vs. State of Maharastra - 1996 (2) SCC 634, this Court held :
"The skill of medical practitioners differs from doctor to doctor. The
nature of the profession is such that there may be more than one course
of treatment which may be advisable for treating a patient. Courts
would indeed be slow in attributing negligence on the part of a doctor
if he has performed his duties to the best of his ability and with due
care and caution. Medical opinion may differ with regard to the course
of action to be taken by a doctor treating a patient, but as long as a
doctor acts in a manner which is acceptable to the medical profession
and the Court finds that he has attended on the patient with due care
skill and diligence and if the patient still does not survive or suffers a
permanent ailment, it would be difficult to hold the doctor to be guilty
of negligence..In cases where the doctors act carelessly and in a
manner which is not expected of a medical practitioner, then in such a
case an action in torts would be maintainable."

In Vinitha Ashok vs. Lakshmi Hospital - 2001 (8) SCC 731, this Court
after referring to Bolam, Sidaway and Achutrao, clarified:
"A doctor will be liable for negligence in respect of diagnosis and
treatment in spite of a body of professional opinion approving his
conduct where it has not been established to the court's satisfaction that
such opinion relied on is reasonable or responsible. If it can be
demonstrated that the professional opinion is not capable of
withstanding the logical analysis, the court would be entitled to hold
that the body of opinion is not reasonable or responsible.

In Indian Medical Association vs. V. P. Shantha - 1995 (6) SCC 651, this
Court held :
"The approach of the courts is to require that professional men should
possess a certain minimum degree of competence and that they should
exercise reasonable care in the discharge of their duties. 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".

Neither Achutrao nor Vinitha Ashok referred to the American view
expressed in Canterbury.

26. In India, majority of citizens requiring medical care and treatment
fall below the poverty line. Most of them are illiterate or semi-literate.
They cannot comprehend medical terms, concepts, and treatment
procedures. They cannot understand the functions of various organs or
the effect of removal of such organs. They do not have access to effective
but costly diagnostic procedures. Poor patients lying in the corridors of
hospitals after admission for want of beds or patients waiting for days on
the roadside for an admission or a mere examination, is a common sight.
For them, any treatment with reference to rough and ready diagnosis
based on their outward symptoms and doctor's experience or intuition is
acceptable and welcome so long as it is free or cheap; and whatever the
doctor decides as being in their interest, is usually unquestioningly
accepted. They are a passive, ignorant and uninvolved in treatment
procedures. The poor and needy face a hostile medical environment -
inadequacy in the number of hospitals and beds, non-availability of
adequate treatment facilities, utter lack of qualitative treatment,
corruption, callousness and apathy. Many poor patients with serious
ailments (eg. heart patients and cancer patients) have to wait for months
for their turn even for diagnosis, and due to limited treatment facilities,
many die even before their turn comes for treatment. What choice do
these poor patients have? Any treatment of whatever degree, is a boon or
a favour, for them. The stark reality is that for a vast majority in the
country, the concepts of informed consent or any form of consent, and
choice in treatment, have no meaning or relevance.

The position of doctors in Government and charitable hospitals, who treat
them, is also unenviable. They are overworked, understaffed, with little or
no diagnostic or surgical facilities and limited choice of medicines and
treatment procedures. They have to improvise with virtual non-existent
facilities and limited dubious medicines. They are required to be
committed, service oriented and non-commercial in outlook. What choice
of treatment can these doctors give to the poor patients? What informed
consent they can take from them?

27. On the other hand, we have the Doctors, hospitals, nursing homes
and clinics in the private commercial sector. There is a general perception
among the middle class public that these private hospitals and doctors
prescribe avoidable costly diagnostic procedures and medicines, and
subject them to unwanted surgical procedures, for financial gain. The
public feel that many doctors who have spent a crore or more for
becoming a specialist, or nursing homes which have invested several
crores on diagnostic and infrastructure facilities, would necessarily
operate with a purely commercial and not service motive; that such
doctors and hospitals would advise extensive costly treatment procedures
and surgeries, where conservative or simple treatment may meet the need;
and that what used to be a noble service oriented profession is slowly but
steadily converting into a purely business.

28. But unfortunately not all doctors in government hospitals are
paragons of service, nor fortunately, all private hospitals/doctors are
commercial minded. There are many a doctor in government hospitals
who do not care about patients and unscrupulously insist upon 'unofficial'
payment for free treatment or insist upon private consultations. On the
other hand, many private hospitals and Doctors give the best of treatment
without exploitation, at a reasonable cost, charging a fee, which is
resonable recompense for the service rendered. Of course, some doctors,
both in private practice or in government service, look at patients not as
persons who should be relieved from pain and suffering by prompt and
proper treatment at an affordable cost, but as potential income-providers/
customers who can be exploited by prolonged or radical diagnostic and
treatment procedures. It is this minority who bring a bad name to the
entire profession.

29. 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 ours 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.
Remarkable developments in the field of medicine might have
revolutionalized 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. Every Doctor wants to be a specialist. The proliferation of
specialists and super specialists, have exhausted many a patient both
financially and physically, by having to move from doctor to doctor, in
search of the appropriate specialist who can identify the problem and
provide treatment. What used to be competent treatment by one General
Practitioner has now become multi-pronged treatment by several
specialists. Law stepping in to provide remedy for negligence or
deficiency in service by medical practioners, has its own twin adverse
effects. More and more private doctors and hospitals have, of necessity,
started playing it safe, by subjecting or requiring the patients to undergo
various costly diagnostic procedures and tests to avoid any allegations of
negligence, even though they might have already identified the ailment
with reference to the symptoms and medical history with 90% certainly,
by their knowledge and experience. Secondly more and more doctors
particularly surgeons in private practice are forced to cover themselves
by taking out insurance, the cost of which is also ultimately passed on to
the patient, by way of a higher fee. As a consequence, it is now common
that a comparatively simple ailment, which earlier used to be treated at
the cost of a few rupees by consulting a single doctor, requires an
expense of several hundred or thousands on account of four factors : (i)
commercialization of medical treatment; (ii) increase in specialists as
contrasted from general practitioners and the need for consulting more
than one doctor; (iii) varied diagnostic and treatment procedures at high
cost; and (iv) need for doctors to have insurance cover. The obvious,
may be naove, answer to unwarranted diagnostic procedures and
treatment and prohibitive cost of treatment, is an increase in the
participation of health care by the state and charitable institutions. An
enlightened and committed medical profession can also provide a better
alternative. Be that as it may. We are not trying to intrude on matters of
policy, nor are we against proper diagnosis or specialisation. We are only
worried about the enormous hardship and expense to which the common
man is subjected, and are merely voicing the concern of those who are
not able to fend for themselves. We will be too happy if what we have
observed is an overstatement, but our intuition tells us that it is an
understatement.

30. What we are considering in this case, is not the duties or
obligations of doctors in government charitable hospitals where treatment
is free or on actual cost basis. We are concerned with doctors in private
practice and hospitals and nursing homes run commercially, where the
relationship of doctors and patients are contractual in origin, the service is
in consideration of a fee paid by the patient, where the contract implies
that the professional men possessing a minimum degree of competence
would exercise reasonable care in the discharge of their duties while
giving advice or treatment.

31. There is a need to keep the cost of treatment within affordable
limits. Bringing in the American concepts and standards of treatment
procedures and disclosure of risks, consequences and choices will
inevitably bring in higher cost-structure of American medical care.
Patients in India cannot afford them. People in India still have great
regard and respect for Doctors. The Members of medical profession have
also, by and large, shown care and concern for the patients. There is an
atmosphere of trust and implicit faith in the advice given by the Doctor.
The India psyche rarely questions or challenges the medical advice.
Having regard to the conditions obtaining in India, as also the settled and
recognized practices of medical fraternity in India, we are of the view that
to nurture the doctor-patient relationship on the basis of trust, the extent
and nature of information required to be given by doctors should continue
to be governed by the Bolam test rather than the 'reasonably prudential
patient' test evolved in Canterbury. It is for the doctor to decide, with
reference to the condition of the patient, nature of illness, and the
prevailing established practices, how much information regarding risks
and consequences should be given to the patients, and how they should be
couched, having the best interests of the patient. A doctor cannot be held
negligent either in regard to diagnosis or treatment or in disclosing the
risks involved in a particular surgical procedure or treatment, if the doctor
has acted with normal care, in accordance with a recognised practices
accepted as proper by a responsible body of medical men skilled in that
particular field, even though there may be a body of opinion that takes a
contrary view. Where there are more than one recognized school of
established medical practice, it is not negligence for a doctor to follow
any one of those practices, in preference to the others.

32. We may now summarize principles relating 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 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
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.

(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.


33. We may note here that courts in Canada and Australia have moved
towards Canterbury standard of disclosure and informed consent - vide
Reibl v. Hughes (1980) 114 DLR (3d.) 1 decided by the Canadian
Supreme Court and Rogers v. Whittaker - 1992 (109) ALR 625 decided
by the High Court of Australia. Even in England there is a tendency to
make the doctor's duty to inform more stringent than Bolam's test adopted
in Sidaway. Lord Scarman's minority view in Sidaway favouring
Canterbury, in course of time, may ultimately become the law in
England. A beginning has been made in Bolitho v. City and Hackney HA
- 1998 1 AC 232 and Pearce v. United Bristol Healthcare NHS Trust
1998 (48) BMLR 118. We have however, 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.

Re : Question No.(iii)

34. 'Gynaecology' (second edition) edited by Robert W. Shah,
describes 'real consent' with reference to Gynaecologists (page 867 et
seq) as follows :

"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. The only available defence will be
that it was necessary for the life of the patient to proceed at once to
remove the ovaries because of some perceived pathology in them.

What is meant by consent? The term 'informed consent' is often used,
but there is no such concept in English law. The consent must be real :
that is to say, the patient must have been given sufficient information
for her to understand the nature of the operation, its likely effects, and
any complications which may arise and which the surgeon in the
exercise of his duty to the patient considers she should be made aware
of; only then can she reach a proper decision. But the surgeon need not
warn the patient of remote risks, any more than an anaesthetist need
warn the patient that a certain small number of those anaesthetized will
suffer cardiac arrest or never recover consciousness. Only where there
is a recognized risk, rather than a rare complication, is the surgeon
under an obligation to warn the patient of that risk. He is not under a
duty to warn the patient of the possible results of hypothetical
negligent surgery. ..

In advising an operation, therefore, the doctor must do so in the way in
which a competent gynaecologist exercising reasonable skill and care
in similar circumstances would have done. In doing this he will take
into account the personality of the patient and the importance of the
operation to her future well being. It may be good practice not to warn
a very nervous patient of any possible complications if she requires
immediate surgery for, say, a malignant condition. The doctor must
decide how much to say to her taking into account his assessment of
her personality, the questions she asks and his view of how much she
understands. If the patient asks a direct question, she must be given a
truthful answer.  To take the example of hysterectomy : although the
surgeon will tell the patient that it is proposed to remove her uterus and
perhaps her ovaries, and describe what that will mean for her future
well being (sterility, premature menopause), she will not be warned of
the possibility of damage to the ureter, vesicovaginal fistula, fatal
haemorrhage or anaesthetic death."


35. The specific case of the appellant was that she got herself admitted
on 10.5.1995 only for a diagnostic laparoscopy; that she was not
informed either on 9th or 10th that she was suffering from endometriosis
or that her reproductive organs had to be removed to cure her from the
said disease; that her consent was not obtained for the removal of her
reproductive organs; and that when she was under general anaesthesia for
diagnostic laparoscopy, respondent came out of the operation theatre and
informed her aged mother that the patient was bleeding profusely which
might endanger her life and hysterectomy was the only option to save her
life, and took her consent.

36. The respondent on the other hand contends that on the basis of
clinical and ultra sound examination on 9.5.1995, she had made a
provisional diagnosis of endometriosis; that on same day, she informed
the complainant and her mother separately, that she would do a diagnostic
laparoscopy on the next day and if the endometric lesion was found to be
mild or moderate, she will adopt a conservative treatment by operative
laparoscopy, but if the lesion was extensive then considering her age and
extent of lesion and likelihood of destruction of the functions of the tube,
a laparotomy would be done; that the appellant was admitted to the
hospital for diagnostic and operative laparoscopy and laparotomy and
appellant's consent was obtained for such procedures; that the decision to
operate and remove the uterus and ovaries was not sudden, nor on
account of any emergent situation developing during laproscopy; and
that the radical surgery was authorized, as it was preceded by a valid
consent. She also contends that as the appellant wanted a permanent cure,
the decision to conduct a hysterectomy was medically correct and the
surgical procedure in fact cured the appellant and saved her intestines,
bladder and ureter being damaged due to extension of the lesion. She had
also tried to justify the surgical removal of the uterus and ovaries, with
reference to the age and medical condition of the complainant.

37. The summery of the surgical procedure (dictated by respondent and
handwritten by her assistant Dr. Lata Rangan) furnished to the appellant
also confirms that no emergency or life threatening situation developed
during laparoscopy. This is reiterated in the evidence of respondent and
Dr. Lata Rangan. In her affidavit dated 16.2.2002 filed by way of
examination-in-chief, the respondent stated :
"15. The laproscopic examination revealed a frozen pelvis and
considering the extent of the lesion it was decided that conservative
surgery was not advisable and the nature of the problem required for its
cure hysterectomy.

16. When the Deponent decided to perform hysterectomy she told
Dr. Lata to intimate the mother of Ms. Samira Kohli of the fact that
hysterectomy was going to be performed on her. No complications had
arisen in the operation theatre and the procedure being performed was
in terms of the consent given by Ms. Samira Kohli herself."


In her affidavit dated 16.2.2002 filed by way of examination-in-chief, Dr.
Lata Rangan stated:
"14. I was in the Operation Theatre alongwith Dr. Prabha
Manchanda. The laproscopic examination revealed a frozen pelvis and
considering the extent of the lesion it was decided that conservative
surgery was not possible and that the nature of the problem required
performance of hysterectomy.

15. When it was decided to perform hysterectomy the deponent
was told by Dr. Prabha Manchanda to intimate the mother of Ms.
Samira Kohli of the fact that hysterectomy was now going to be
performed on her. No complications had arisen in the Operation
Theatre and the procedure conducted therein was in terms of the
consent given by Ms. Samira Kohli herself. I got the mother to sign the
Form too so that the factum of intimation was duly documented."


Thus, the respondent's definite case is that on 9.5.1995, the respondent
had provisionally diagnosed endometriosis and informed the appellant;
that appellant had agreed that hysterectomy may be performed if the
lesion was extensive; and that in pursuance of such consent, reiterated in
writing by the appellant in the consent form on 10.5.1995, she performed
the AH-BSO removing the uterus and ovaries on finding extensive
endometriosis. In other words, according to respondent, the abdominal
hysterectomy and bilateral salpingo-oopherectomy (AH-BSO) was not
necessitated on account of any emergency or life threatening situation
developing or being discovered when laparoscopic test was conducted,
but according to an agreed plan, consented by the appellant and her
mother on 9.5.1995 itself, reiterated in writing on 10.5.1995. Therefore
the defence of respondent is one based on specific consent. Let us
therefore examine whether there was consent.

38. The Admission and Discharge card maintained and produced by
the respondent showed that the appellant was admitted "for diagnostic
and (?)operative laparoscopy on 10.5.1995". The OPD card dated
9.5.1995 does not refer to endometriosis, which is also admitted by the
respondent in her cross-examination. If fact, the respondent also admitted
that the confirmation of diagnosis is possible only after laparoscopy test :
"On clinical and ultrasound examination a diagnosis can be made to
some extent. But precise diagnosis will have to be on laparoscopy."

The consent form dated 10.5.1995 signed by the appellant states that
appellant has been informed that the treatment to be undertaken is
"diagnostic and operative laparoscopy. Laparotomy may be needed." The
case summary dictated by respondent and written by Dr. Lata Rangan
also clearly says "admitted for Hysteroscopy, diagnostic laparoscopy and
operative laparoscopy on 10.5.1995." (Note : Hysteroscopy is inspection
of uterus by special endoscope and laproscopy is abdominal exploration
by special endoscope.)

39. In this context, we may also refer to a notice dated 5.6.1995 issued
by respondent to the appellant through counsel, demanding payment of
Rs.39,325/- towards the bill amount. Paras 1, 3, and 4 are relevant which
are extracted below :

"1. You were admitted to our clinic Dr. Manchanda, No.7, Ring
Road, Lajpat Nagar, New Delhi for diagnostic and operative
laparoscopy and Endometrial biopsy on 10.5.1995." ..

"3. The findings of laparoscopy were : a very extensive lesion of
the endometriosis with pools of blood, extensive adherence involving
the tubes of the uterus and ovaries, a chocolate cyst in the right ovary
and areas of endometriosis on the surface of the left ovary but no cyst."

"4. The findings were duly conveyed to Ms. Somi Kohli who was
also shown a video recording of the lesion. You and Mrs. Somi Kohli
were informed that conservative surgery would be futile and removal
of the uterus and more extensive surgery, considering your age and
extensive lesion and destruction of the functions of the tubes, was
preferable."


This also makes it clear that the appellant was not admitted for
conducting hysterectomy or bilateral salpingo-oopherectomy, but only for
diagnostic purposes. We may, however, refer to a wrong statement of fact
made in the said notice. It states that on 10.5.1995 after conducting a
laparoscopic examination, the video-recording of the lesion was shown to
appellant's mother, and the respondent informed the appellant and her
mother that conservative surgery would be futile and removal of uterus
and more extensive surgery was preferable having regard to the more
extensive lesion and destruction of the function of the tubes. But this
statement cannot be true. The extensive nature of lesion and destruction
of the functions obviously became evident only after diagnostic
laparoscopy. But after diagnostic laparoscopy and the video recording of
the Lesion, there was no occasion for respondent to inform anything to
appellant. When the laparoscopy and video recording was made, the
appellant was already unconscious. Before she regained consciousness,
AH-BSO was performed removing her uterus and ovaries. Therefore, the
appellant could not have been informed on 10.5.1995 that conservative
surgery would be futile and removal of uterus and extensive surgery was
preferable in view of the extensive lesion and destruction of the function
of the tubes did not arise.

40. The admission card makes it clear that the appellant was admitted
only for diagnostic and operative laparoscopy. It does not refer to
laparotomy. The consent form shows that the appellant gave consent only
for diagnostic operative laparoscopy, and laparotomy if needed.
Laparotomy is a surgical procedure to open up the abdomen or an
abdominal operation. It refers to the operation performed to examine the
abdominal organs and aid diagnosis. Many a time, after the diagnosis is
made and the problem is identified it may be fixed during the laparotomy
itself. In other cases, a subsequent surgery may be required. Laparotomy
can no doubt 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 slapingo-oopherectomy follow laparotomy and are not
themselves referred to as laparotomy. Therefore, 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. It does not amount to consent for OH-BSO surgery
removing the uterus and ovaries/fallopian tubes. If the appellant had
consented for a OH-BSO then the consent form would have given
consent for "diagnostic and operative laparoscopy. Laparotomy,
hysterectomy and bilateral salpingo-oopherectomy, if needed."


41. On the documentary evidence and the histopathology report the
appellant also raised an issue as to whether appellant was suffering from
endometriosis at all. She points out that ultra-sound did not disclose
endometriosis and the histopathology report does not confirm
endometriosis. The respective experts examined on either side have
expressed divergent views as to whether appellant was suffering from
endometriosis. It may not be necessary to give a definite finding on this
aspect, as the real question for consideration is whether appellant gave
consent for hysterectomy and bilateral salpingo-oopherectomy and not
whether appellant was suffering from endometriosis. Similarly there is
divergence of expert opinion as to whether removal of uterus and ovaries
was the standard or recognized remedy even if there was endometriosis
and whether conservative treatment was an alternative. Here again it is
not necessary to record any finding as to which is the proper remedy. It is
sufficient to note that there are different modes of treatment favoured by
different schools of thought among Gynaecologists.

42. Respondent contended that the term 'laparotomy' is used in the
consent form (by her assistant Dr. Lata Rangan) is equal to or same as
hysterectomy. The respondent's contention that 'Laparotomy' refers to and
includes hystectomy and bilateral salpingo-oopherectomy cannot be
accepted. The following clear evidence of appellant's expert witness --
Dr. Puneet Bedi (CW 1) is not challenged in cross examination :
"Laparotomy is opening up of the abdomen which is quite different
from hysterectomy. Hysterectomy is a procedure which involves
surgical removal of uterus. The two procedures are totally different and
consent for each procedure has to be obtained separately."

On the other hand, the evidence of respondent's expert witness (Dr. Sudha
Salhan) on this question is evasive and clearly implies laparotomy is not
the same as hysterectomy. The relevant portion of her evidence is
extracted below :

"Q. As per which medical authority, laparotomy is equal to
hysterectomy?

Ans. Consent for laparotomy permits undertaking for such surgical
procedure necessary to treat medical conditions including
hysterectomy.

Q. I put it to you that the medical practice is to take specific consent
for hysterectomy.

Ans. Whenever we do hysterectomy only, specific consent is
obtained."


43. Medical texts and authorities clearly spell out that Laparotomy is at
best the initial step that is necessary for performing hysterectomy or
salpingo-oopherectomy. Laparotomy by itself is not hysterectomy or
salpingo-oopherectomy. Nor does 'hysterectomy' include salpingo-
oopherectomy, in the case of woman who has not attained menopause.
Laparotomy does not refer to surgical removal of any vital or
reproductive organs. Laparotomy is usually exploratory and once the
internal organs are exposed and examined and the disease or ailment is
diagnosed, the problem may be addressed and fixed during the course of
such laparotomy (as for example, removal of cysts and fulguration of
endometric area as stated by respondent herself as a conservative form of
treatment). But Laparotomy is never understood as referring to removal
of any organ. In medical circles, it is well recognized that a 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. For example, a surgeon cannot construe a consent to
termination of pregnancy as a consent to sterilize the patient.

44. When the oral and documentary evidence is considered in the light
of the legal position discussed above while answering questions (i) and
(ii), it is clear that there was no consent by the appellant for conducting
hysterectomy and bilateral salpingo-oopherectomy.

45. The Respondent next contended that the consent given by the
appellant's mother for performing hysterectomy should be considered as
valid consent for performing hysterectomy and salpingo-oopherectomy.
The appellant was neither a minor, nor mentally challenged, nor
incapacitated. When a patient is a competent adult, there is no question of
someone else giving consent on her behalf. There was no medical
emergency during surgery. The appellant was only temporarily
unconscious, undergoing only a diagnostic procedure by way of
laparoscopy. The respondent ought to have waited till the appellant
regained consciousness, discussed the result of the laparoscopic
examination and then taken her consent for the removal of her uterus and
ovaries. In the absence of an emergency and as the matter was still at the
stage of diagnosis, the question of taking her mother's consent for radical
surgery did not arise. Therefore, such consent by mother cannot be
treated as valid or real consent. Further a consent for hysterectomy, is not
a consent for bilateral salpingo - ooperectomy.

46. There is another facet of the consent given by the appellant's
mother which requires to be noticed. The respondent's specific case is that
the appellant had agreed for the surgical removal of uterus and ovaries
depending upon the extent of the lesion. It is also her specific case that
the consent by signing the consent form on 10.5.1995 wherein the
treatment is mentioned as "diagnostic and operative laparoscopy.
Laparotomy may be needed." includes the AH-BSO surgery for removal
of uterus and ovaries. If the term 'laparotomy' is to include hysterectomy
and salpingo-oopherectomy as contended by the respondent and there
was a specific consent by the appellant in the consent form signed by her
on 10.5.1995, there was absolutely no need for the respondent to send
word through her assistant Dr. Lata Rangan to get the consent of
appellant's mother for performing hysterectomy under general anesthesia.
The very fact that such consent was sought from appellant's mother for
conducting hysterectomy is a clear indication that there was no prior
consent for hysterectomy by the appellant.

47. We may, therefore, summarize the factual position thus :

(i) On 9.5.1995 there was no confirmed diagnosis of endometriosis.
The OPD slip does not refer to a provisional diagnosis of
endometriosis on the basis of personal examination. Though there
is a detailed reference to the findings of ultrasound in the entry
relating to 9.5.1995 in the OPD slip, there is no reference to
endometriosis which shows that ultrasound report did not show
endometriosis. In fact, ultra-sound may disclose fibroids, chocolate
cyst or other abnormality which may indicate endometriosis, but
cannot by itself lead to a diagnosis of endometriosis. This is
evident from the evidence of CW1, RW1 and RW2 and recognized
text books. In fact respondent's expert Dr. Sudha Salhan admits in
her cross examination that endometriosis can only be suspected but
not diagnosed by ultrasound and it can be confirmed only by
laparoscopy. Even according to respondent, endometriosis was
confirmed only by laparoscopy. [Books on "Gynaecology' clearly
state : "The best means to diagnose endometriosis is by direct
visualization at laparoscopy or laparotomy, with histological
confirmation where uncertainty persists."] Therefore the claim of
respondent that she had discussed in detail about endometriosis and
the treatment on 9.5.1995 on the basis of her personal examination
and ultra-sound report appears to be doubtful.

(ii) The appellant was admitted only for diagnostic laparoscopy (and at
best for limited surgical treatment that could be made by
laproscopy). She was not admitted for hysterectomy or bilateral
salpingo-oopherectomy.

(iii) There was no consent by appellant for hysterectomy or bilateral
salpingo-oopherectomy. The words "Laparotomy may be needed"
in the consent form dated 10.5.1995 can only refer to therapeutic
procedures which are conservative in nature (as for example
removal of chocolate cyst and fulguration of endometric areas, as
stated by respondent herself as a choice of treatment), and not
radical surgery involving removal of important organs.

48. We find that the Commission has, without any legal basis,
concluded that "the informed choice has to be 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". It also
erred in construing the words "such medical treatment as is considered
necessary for me for." in the consent form as including surgical
treatment by way of removal or uterus and ovaries. The Commission has
also observed : "whether the uterus should have been removed or not or
some other surgical procedure should have been followed are matters to
be left to the discretion of the performing surgeon, as long as the surgeon
does the work with adequate care and caution". This proceeds on the
erroneous assumption that where the surgeon has shown adequate care
and caution in performing the surgery, the consent of the patient for
removal of an organ is unnecessary. The Commission failed to notice that
the question was not about the correctness of the decision to remove the
uterus and ovaries, but the failure to obtain the consent for removal of
those important organs. There was a also faint attempt on the part of the
respondent's counsel to contend that what were removed were not 'vital'
organs and having regard to the advanced age of the appellant, as
procreation was not possible, uterus and ovaries were virtually redundant
organs. The appellant's counsel seriously disputes the position and
contends that procreation was possible even at the age of 44 years.
Suffice it to say that for a woman who has not married and not yet
reached menopause, the reproductive organs are certainly important
organs. There is also no dispute that removal of ovaries leads to abrupt
menopause causing hormonal imbalance and consequential adverse
effects.

Re : Question Nos.(iv) and (v) :


49. The case of the appellant is that she was not suffering from
endometriosis and therefore, there was no need to remove the uterus and
ovaries. In this behalf, she examined Dr. Puneet Bedi (Obstetrician and
Gynaecologist) who gave hormone therapy to appellant for about two
years prior to his examination in 2002. He stated that the best method to
diagnose endometriosis is diagnostic laparoscopy; that the presence of
endometrial tissue anywhere outside the uterus is called Endometriosis;
that the Histopathology report did not confirm endometriosis in the case
of appellant; and that the mode of treatment for endometriosis would
depend on the existing extent of the disease. He also stated that removal
of uterus results in abrupt menopause. In natural menopause, which is a
slow process, the body gets time to acclimatize to the low level of
hormones gradually. On the other hand when the ovaries are removed,
there is an abrupt stoppage of natural hormones and therefore Hormone
Replacement Therapy is necessary to make up the loss of natural
hormones. Hormone Replacement Therapy is also given even when there
is a natural menopause. But hormone replacement therapy has side effects
and complications. He also stated that on the basis of materials available
on the file, he was of the view that Hysterectomy was not called for
immediately. But if endometriosis had been proven from history and
following diagnostic laparoscopy, hysterectomy could be considered as a
last resort if all other medical methods failed. What is relevant from the
evidence of Dr. Puneet Bedi, is that he does not say that hysterectomy is
not the remedy for endometriosis, but only that it is a procedure that has
to be considered as a last resort.

50. On the other hand, the respondent who is herself a experienced
Obstetrician and Gynaecologist has given detailed evidence, giving the
reasons for diagnosing the problem of appellant as endometriosis and has
referred to in detail, the need for the surgery. She stated that having
regard to the medical condition of complainant, her decision to perform
hysterectomy was medically correct. The complainant wanted a cure for
her problem and the AH-BSO surgery provided her such cure, apart from
protecting her against any future damage to intestines, bladder and ureter.
She explained that if the uterus and ovaries had not been removed there
was a likelihood of lesion extending to the intestines causing bleedings,
fibrosis and narrowing of the gut; the lesion could also go to the surface
of the bladder penetrating the wall and causing haematuria and the ureter
could be damaged due to fibrosis leading to damage of the kidney; there
was also a chance of development of cancer also. She also pointed out
that the complainant being 44 years of age, was in the pre-menopausal
period and had menorrhagia which prevented regular ovulation which
was necessary for pregnancy; that endometriosis also prevented
fertilization and produced reaction in the pelvis which increased
lymphocytes and macrophages which destroy the ova and sperm; and
that the state of bodily health did not depend upon the existence of uterus
and ovaries.

51. The respondent also examined Dr. Sudha Salhan, Professor and
Head of Department (Obstetrics and Gynaecology) and President of the
Association of Obstetricians and Gynaecologists of Delhi. Having seen
the records relating to appellant including the record pertaining to clinical
and ultra-sound examinations, she was of the view that the treatment
given to appellant was correct and appropriate to appellant's medical
condition. She stated that the treatment is determined by severity of the
disease and hysterectomy was not an unreasonable option as there was no
scope left for fecundability in a woman aged 44 years suffering from
endometriosis. She also stated that the histopathology report dated
15.5.1995 confirmed the diagnosis of endometriosis made by respondent.
She also stated that she saw video-tape of the laparoscopic examination
and concurred that the opinion of respondent that the lesion being
extensive conservation surgery was not possible and the problem could
effectively be addressed only by more extensive surgery that is removal
of the uterus and ovaries. She also stated that the presence of chocolate
cyst was indicative of endometriosis. She also stated that medication
merely suppresses endometriosis and the definitive treatment was surgical
removal of the uterus and both the ovaries. She also stated that
hysterectomy is done when uterus comes out from a prolapse and the
woman is elderly, or when there is a cancer of the uterus, or when there
are massive fibroids or when a severe grade of endometriosis along with
ovaries or in cases of malignancy or the cancer of the ovaries.

52. The evidence therefore demonstrates that on laparoscopic
examination, respondent was satisfied that appellant was suffering from
endometriosis. The evidence also demonstrates that there is more than
one way of treating endometriosis. While one view favours conservative
treatment with hysterectomy as a last resort, the other favours
hysterectomy as a complete and immediate cure. The age of the patient,
the stage of endometriosis among others will be determining factors for
choosing the method of treatment. The very suggestion made by
appellant's counsel to the expert witness Dr. Sudha Salhan that worldwide
studies show that most hysterectomies are conducted unnecessarily by
Gynecologists demonstrates that it is considered as a favoured treatment
procedure among medical fraternity, offering a permanent cure. Therefore
respondent cannot be held to be negligent, merely because she chose to
perform radical surgery in preference to conservative treatment. This
finding however has no bearing on the issue of consent which has been
held against the respondent. The correctness or appropriateness of the
treatment procedure, does not make the treatment legal, in the absence of
consent for the treatment.

53. It is true that the appellant has disputed the respondent's finding
that she was suffering from endometriosis. The histopathology report also
does not diagnose any endometriosis. The expert witness examined on
behalf of the appellant has also stated that there was no evidence that the
appellant was suffering from endometriosis. On the other hand the
respondent has relied on some observations of the histopathology report
and on her own observations which has been recorded in the case
summary to conclude that the appellant was suffering from
endometriosis. The evidence shows that the respondent having found
evidence of endometriosis, proceeded on the basis that removal of uterus
and ovaries was beneficial to the health of the appellant having regard to
the age of the appellant and condition of the appellant to provide a
permanent cure to her ailment, though not authorized to do so. On a
overall consideration of the evidence, we are not prepared to accept the
claim of appellant that the respondent falsely invented a case that the
appellant was suffering from endometriosis to cover up some negligence
on her part in conducting the diagnostic/operative laparoscopy or to
explain the unauthorized and unwarranted removal of uterus and ovaries.

Re : Question No.(vi) :

54. In view of our finding that there was no consent by the appellant
for performing hysterectomy and salpingo-oopherectomy, performance of
such surgery was an unauthorized invasion and interference with
appellant's body which amounted to a tortious act of assault and battery
and therefore a deficiency in service. But as noticed above, there are
several mitigating circumstances. The respondent did it in the interest of
the appellant. As the appellant was already 44 years old and was having
serious menstrual problems, the respondent thought that by surgical
removal of uterus and ovaries she was providing permanent relief. It is
also possible that the respondent thought that the appellant may approve
the additional surgical procedure when she regained consciousness and
the consent by appellant's mother gave her authority. This is a case of
respondent acting in excess of consent but in good faith and for the
benefit of the appellant. Though the appellant has alleged that she had to
undergo Hormone Therapy, no other serious repercussions is made out as
a result of the removal. The appellant was already fast approaching the
age of menopause and in all probability required such Hormone Therapy.
Even assuming that AH-BSO surgery was not immediately required,
there was a reasonable certainty that she would have ultimately required
the said treatment for a complete cure. On the facts and circumstances,
we consider that interests of justice would be served if the respondent is
denied the entire fee charged for the surgery and in addition, directed to
pay Rs.25,000 as compensation for the unauthorized AH-BSO surgery to
the appellant.

55. We accordingly allow this appeal and set aside the order of the
Commission and allow the appellant's claim in part. If the respondent has
already received the bill amount or any part thereof from the appellant
(either by executing the decree said to have been obtained by her or
otherwise), the respondent shall refund the same to the appellant with
interest at the rate of 10% per annum from the date of payment till the
date of re-payment. The Respondent shall pay to the appellant a sum of
Rs.25,000/- as compensation with interest thereon at the rate of 10% per
annum from 19.11.2003 (the date of the order of Commission) till date of
payment. The appellant will also be entitled to costs of Rs.5,000 from the
respondent.