CHAPTER I

Introduction, Background and

Literature Review

1
“From inability to leave well alone; from too much zeal for the new and contempt for
what is old; from putting knowledge before wisdom, science before art, cleverness
before commonsense; from treating patients as cases; and for making cure of a
disease more grievous than the endurance, good Lord, deliver.”
Robert Hutchison1

1.1 Introduction

“The customer is King”-though an old adage, yet, in spite of managerial checks for
quality, at the manufacturing end, the customer walks through against all odds.
Duplications and legal checks and measures did not guarantee him the minimum
and made him more vulnerable. The professional services did not lag behind. And,
the good, the bad and the ugly standards in service quality in contrast rendered the
very existence of common person- the consumer at peril. Not that the existing law
lacks in its operative coverage for any such lapses. Yet, a milestone, in the
consumer protection, special law ushered with a special protective coverage.
Amongst all professional services, the medical field has become most expansive in
the first instance and others to fall in line. Extension of corporate approach in
services and the health consciousness by one and all brought in a situation for
medical attention at a far in advance stage even before one gets ill. Healthy persons
are taking more pills than one who suffers. However, the field at both ends, i. e. the
persons getting treated or the treating professionals are at total bay, due to lack of
awareness as to their rights and obligations.2

Highlighting cases of medical negligence has ever been a trait of yellow journalism
and probably these phenomena cannot be checked. It is to be realized that looking
from journalistic point of view, “if a dog bites a man it may or may not be news, but if
a man bites a dog it is news”. So also if medical profession cures many with its
knowledge and expertise it is no longer newsworthy, but a forceps left inside the
body during an operation by an otherwise eminent surgeon through an oversight is
definitely newsworthy. Public sympathy on so emotional issue is overall in favour of

1
Russel,et al.(eds),2004 as cited in Tapas Kumar Koley, MEDICAL NEGLIGENCE AND

MEDICOLEGAL ASPECTS OF PATIENT CARE (New Delhi, Mehta Publishers, 2004)

2 st
B.Prakash Rao & Justice Y.V.Rao, LAW RELATING TO MEDICAL NEGLIGENCE,1 edition,2006 ,
Forward
2
this step to bring greater accountability in the medical profession. For the doctors
point the best policy would be to let the issue take its natural course with gradual
maturity of the process, bringing about the desired changes ensuring justice to both
sides. Meanwhile the medical profession has to deal with this issue like with any
other disease i.e. in a practical and sensible manner. Before tackling any issue it is
important to know as much about it as possible.3

One of the most important aspects of any profession is the degree of excellence in
results that a person practicing that profession can give. It is not at all expected that
each and every professional would deliver the goods in the same expertise. There
are so many aspects and factors that determine the relative competence of an
individual in a group, vocation or a particular line of personalized and highly skilled
practice. What is important is that one acts, conducts himself and discharges his
duties in such a manner as would be expected from a prudent contemporary in a
similar situation having access to similar facilities and in the know-how of the
principles of such a practice in general. One can leave some room for factors like
standards of basic education, facilities regarding initial period of training and
specialized exposure, conditions of exigencies and stress while executing a given
assignment and the like which in the ordinary course of day to day life are sufficient
to lead to a difference of performance. But certainly there is no escape at all for
contumacious recklessness, blatant dereliction of duty or complete misapplication of
mind which comprised of one of the above or several acts or omissions leading to a
negligent act and this untoward act is negligence.4

Health is a state of complete physical, mental and social well-being and not merely
the absence of disease or infirmity. The enjoyment of the highest attainable standard
of health is one of the fundamental rights of every human being without distinction of
race, religion, and political belief, economic or social condition. The health of all
peoples is fundamental to the attainment of peace and security and is dependent
upon the fullest co-operation of individuals and States. The achievement of any State
in the promotion and protection of health is of value to all. Unequal development in
different countries in the promotion of health and control of disease, especially

3
Neeraj Nagpal, COMPENDIUM OF CPA MEDICAL JUDGMENTS: INTRODUCTION, Chandigarh,
Neelam Prakashan 1996
4
Anoop K. Kaushal, Medical Negligence and Liabilities of a Doctor-MEDICAL NEGLIGENCE AND
rd
LEGAL REMEDIES, 3 edition Delhi, Universal Law publishing, 2004, pp. 8
3
communicable disease, is a common danger. Healthy development of the child is of
basic importance; the ability to live harmoniously in a changing total environment is
essential to such development. The extension to all peoples of the benefits of
medical, psychological and related knowledge is essential to the fullest attainment of
health. Informed opinion and active co-operation on the part of the public are of the
utmost importance in the improvement of the health of the people. Governments
have a responsibility for the health of their peoples, which can be fulfilled only by the
provision of adequate health and social measures.5

The diagnosis and the treatment of diseases pertaining to human beings are very
risky professions as they are accompanied by a high degree of morbidity and
mortality. Previously medical professionals were mainly worried about failing to save
the life of a patient or providing satisfactory treatment to a sick person. Now they
also worry about the legal consequences of their failure. So, to this ancient risk of
professional failure has been added the modern risk of providing economic
compensation for the damage caused to the patient as a result of actual or perceived
negligent treatment.6

The nature of relationship between doctors and patients is determined largely by the
practice of the medical profession and shaped by a strong commitment to long
standing principles of medical ethics. The law plays a significant role, however, in
providing a structure within which the doctor patient relationship is conducted.
Whether it is civil, criminal or consumer law, these can only set the outer limits of
acceptable conduct, i.e., a “minimal standard of professional care and skill, leaving
the question of “ideal” standards to the profession itself. Most doctors seem to carry
a notion that the law sets high a standard which does not take in to account the
intricacies of medical science. This is far from being true. The courts are rather
considerate towards them. This is clearly evident from their decisions. In practice
medical negligence means failure to live up to minimal standards of reasonable care
and skill, and those standards are set not by the courts but by professionals
themselves.7

5
Ravi Duggal, Healthcare Case Law in India, Report, CEHAT, 2007; pp.8
6 st
Tapas Kumar Koley, MEDICAL NEGLIGENCE AND THE LAW IN INDIA: INTRODUCTION,1
edition, Oxford University Press,2010; pp.130-138.
7
Jagdish Singh& Vishwa Bhushan, MEDICAL NEGLIGENCE AND COMPENSATION, 3rd edition
2004, reprint with up-to-date Case-law 2007, pp.12.

4
The law relating to medical negligence finds its genesis in the common law
principles of Negligence and was further developed by the judicial pronouncements
in the western world. India was no exception to this legal development as one of the
first reported judgments in a case of medical negligence dates back to 1969, i. e.,
case of Laxman v/s Godbole 8 wherein the Hon‟ble Supreme Court of India dealt in
detail about the principles involved in medical negligence and further elaborated the
duties of doctor and also patients. Not much of hue and cry was raised by the
medical fraternity at that point of time, because till then the doctor patient relationship
had element of trust in it. Moreover, medical profession was taken to be one of most
noble professions on earth.9
Negligence can be described as failure to take due care, as a result of which injury
ensues. It is not sufficient that the medical professional acted in good faith to best of
his or her judgment and belief. A medical professional is expected to have a requisite
degree of skill and knowledge. Medical malpractice is not merely the negligence on
the part of care giver but it is a conscious decision of the care giver to offer and /or
force a product, procedure or investigation upon a patient for monetary gain either
personally or for the institution.10

Three essential components of the modern tort of Negligence propounded by Percy

and Charles worth are as follows; 11
 The existence of duty to take care , which is owed by the defendant to the
complainant;
 The failure to attain the standard of care, prescribed by the law, thereby breach of
such duty; and
 Damage, which is both causally connected to such breach and recognized by the
law, has been suffered by the complainant

8
AIR 1969 SC 129.
9
Vidya Yeravdekar & Dr.Ravi Bhardwaj, MEDICAL NEGLIGENCE CASE REPORTER: First Edition,
Pune, Symbiosis Centre of Healthcare, 2003. Preface
10
. Mihir Desai & Mahabal Kamayani Bali, HEALTH CARE CASE LAW IN INDIA- A READER;
REPORT, Mumbai; CEHAT and ICHRL, 2007, pp.163.

11
. R.K.Bag, LAW OF MEDICAL NEGLIGENCE AND COMPENSATION; Second edition 2003;
Eastern Law House, pp. 4.
5
If the plaintiff proves that the doctor was negligent, but fails to establish that any loss
or injury was caused thereby, then he/she will not be entitled to claim any
compensation.12 The general test for causation requires the plaintiff to establish that
the injury would not have occurred, but for the negligence of the defendant. 13

14
Since the application of the Consumer Protection Act (herein after CPA) to the
medical field in 1995 in India15, there have been a large numbers of cases against
doctors and there have been many settled principles of law. As per these principles
16
the law has defined responsibilities of doctors and hospitals which include;
 To obtain an informed consent of a patient
 To conduct necessary pre-operative diagnostic tests
 To exercise due care and diligence
 To provide information regarding Birth, Death etc and Certification of Health
condition
 Maintenance of Secrecy
 Issuance of death certificate
 Employment of qualified staff, supervision, provision of Ancillary services and
engagement of Specialists
 Provision and testing of blood
 In complicated cases assistance of experts/ consultants in relevant field should
be availed

While “to err is human”, a hospital and medical professionals entrusted with
treatment and often with life of a patient, who generally follows the advice of the
professionals unquestioningly, are expected to exercise greater degree of care while
discharging their duties. 17

12
Sidhraj Dhadda v State of Rajasthan AIR 1994 Raj 68; 1993(1) Raj LW 532. as quoted by Dr.
.R.K.Bag (2003); pp. 4
13
Athey v Leonati [1996] 3 RCS 458 as quoted by Dr.RK Bag (2003) pp. 4
14
See details in Annexure II
15
IMA v. VP Shantha and Ors; AIR 1996 SC 550:1995(6) SCC651: 1995(3): CPJ 1(SC): 1995(3)
CPR412 (SC)

16
M.S. Pandit, & Shobha Pandit, MEDICO LEGAL AID TO HOSPITALS & DOCTORS WITH
nd
CONSUMER PROTECTION LAW, 2 edition, pp. 1-14.

17
Id.
6
From the judgments given by Supreme Court, High Courts and State and National
Commissions various legal principles have emerged which have the guided the
outcome of the nature of the further cases of medical negligence.18
The list is as follows,

1. Res ipsa loquitor: infer from things

2. No privilege to any school of medicine where more than one school of medicine
exists.
3. Expert evidence is required
4. Vexatious litigation
5. Demand of exorbitant fee
6. Where complainant does not prove medical negligence, no liability can be
fastened on the doctor or the hospital. Burden of proof is on the complainant.
7. While code of medical ethics requires a doctor to maintain secrecy and
confidentiality, “Right to Life” of an individual as fundamental right is an exception
to this rule.
8. Standard of care and skill or judgment or technique used by a doctor
9. Nexus between injury and breach of duty on the part of medical professional or
hospital
10. Forseeability and remoteness of injury
11. Inherent risk of surgery and treatment
12. Error of Judgment
13. Provision of blood
14. Transfer of serious patient from one hospital to another
15. Where non specialists, Health Care workers, Nurses and juniors are held
negligent
16. A consultant is negligent if he delegates the responsibilities to a junior
17. Incomplete medical records

18
M.S. Pandit, & Shobha Pandit, MEDICO LEGAL AID TO HOSPITALS & DOCTORS WITH
nd
CONSUMER PROTECTION LAW, 2 edition, pp. 178-203.

7
18. Law prohibits ayurvedic, unani or homeopathic doctor prescribing allopathic
medicine

1.2 Need for the present Study

Legislations such as CPA are important for the simple reason that they, in a specific
manner, operationalize policies of the government. For that matter, the legislation is
only one part of the policy literature available for undertaking policy analysis. This
does not mean that the legislation always follows the policy. There are instances
when the legislation (the law ordinances) are passed first, giving an indication of the
policy being pursued by the state. There are also instances, numerous in the field of
health care, when no legislation follows the announced policy and thereby, leaving
the implementation of the announced policy at the discretion of the administrators
and the political environment prevalent. Thus, the legislation cannot be looked at in
vacuum; they must be understood in relation to policies.19

Practice of medicine is capable of rendering great service to the society provided

due care, efficiency and skills are observed by the doctors. Medical Profession has
its own ethical parameters and code of conduct. This profession is rendering a noble
service to humanity and has sustained itself on public trust. According to the
Voluntary Health Association of India, the present state of medical profession seems
to mirror the rot, which seems to have sent in to the system. Increased
mechanization and commercialization of profession have brought in an element
dehumanization in medical practice. Healthcare has been reduced to business which
determines the doctor patient relationship.20

The concept of “consumer” arises from western countries. It is very much useful to
study the concept, while applying it to the medical field. The applicability of this
concept to the Indian context is a research area itself. There is need for more
research, to evaluate the current and changing trends in the laws related to the
medical negligence. The research is needed to bring out the lacunae, to suggest the
changes that are acceptable to medical field and the consumers.
19
Amar Jesani, Laws and Health Care Providers, Report1996; CEHAT; pp. 8.
20
Samikshya Baskota, Medical Negligence and Consumer Protection Law, An Analytical study of
Medical Negligence and its relation with Consumer Protection Act of Nepal.
http://www.ksl.edu.np/cpanel/pics/medical_negligence_samikshya.pdf

8
Since the application of the Consumer Protection Act, due to Judicial Activism a
number of legal principles have evolved. The patient has been equated to consumer
and this has affected the relationship between doctor and patient. There are number
of other factors which are responsible for the decline in Doctor-Patient relationship
like advancement of the technology in healthcare, commercialization of the
healthcare sector, growth of corporate hospitals and so on. Any medico legal case is
a confrontation between medical knowledge of a lawyer and the legal knowledge of a
doctor. India is a developing country where it has peculiar characteristics like
majority of rural population, Illiteracy and lack of awareness about the consumer
rights and legal provisions
In this context the following areas need to be explored.
1. Increased Litigation
2. Weak Control of Law Provisions
3. Variable Consumer Awareness
4. Link between increased litigation and the consumer awareness
5. Illiteracy
6. Poor Medical Infrastructure
7. Discrepancies in Private and Public Sector Healthcare
8. Role of Quacks
9. Gradual Lifestyle Changes
10. Cross Pathy Practice
11. Trends in the litigations against Medical Persons.
12. Judges‟ unawareness of medical uncertainty

It shows that there is a gap in the knowledge about the above aspects .The
limitations for the applicability of the Consumer Protection Act to the Indian health
circumstances need to be probed. Considering the above aspects of Indian context,
there is a need for further research regarding linking of consumer rights and patients
rights to the laws of medical negligence.

Thus probing in the overall aspects of the applicability of the Consumer Protection
Act to the medical field is necessary to find out grey areas which can be tackled by
solutions that can be suggested thereafter.
9
1.3 Review of Literature
Law is an instrument of social change. It brings about the change in the society
based on the principles of justice and social equity. Law protects the rights of the
common People. The instrument is utilized frequently, when the rights of common
people are affected. Whenever the procedure involved in the application of the law is
simple, it is utilized to the maximum extent by them, for which there needs an
awareness of the law in the society.21

Since the application of the Consumer Protection Act to the medical field22, there has
been an increase in the awareness about the Medical Negligence in the society. In
the Landmark case, IMA v VP Shantha and Others,23 the Hon‟ble Supreme Court
has applied seal of approval on the application of The Consumer Protection Act to
the members of medical profession. In the current scenario, there is a phenomenal
rise in cases involving alleged medical negligence.24

The Consumer Protection Act aims at better protection of the interests of consumers
and for settlement of consumer disputes. It provides for speedy and inexpensive
settlement of disputes within a limited timeframe.25. It has been found that, there is a
changing trend in the law of medical negligence. The changing trend in the judicial
and legislative approach towards the cases of medical malpractice needs to be
studied in depth and there is need to find out lacunae for correction in the Consumer
Protection Act.

“The principle objective of the medical profession is to render services to the

humanity with full respect to the dignity of men.”

21 st
Tapas Kumar Koley, MEDICAL NEGLIGENCE AND THE LAW IN INDIA: INTRODUCTION,1
edition, Oxford University Press,2010; p 21
22
AIR 1996 SC 550: 1995 (6) SCC 651:1995(3) CPJ 1(SC): 1995(3) CPR 412 (SC)

23
Id.12
24
Mihir Desai & Mahabal Kamayani Bali, Health Care Case Law in India- A Reader, Report 2007,
CEHAT and ICHRL, Mumbai, pp. 163

25
Jagdish Singh& Vishwa Bhushan, Medical Negligence and Compensation, 3rd edition 2004, reprint
with up-to-date Case-law 2007, pp. 15.
10
 American Medical Associations principle on Medical Ethics 26

For ages, medical practice has been treated as a noble profession. The relationship
between a patient and his/her family doctor was once of trust and total confidence on
the part of the patient and one of care and concern on the part of the doctor. The
disappearance of the concept of family doctor and the rapid growth of super
specialty corporate hospitals in the urban areas has totally changed the age-old
doctor-patient relationship based on long-term association and trust.27

Profession
Scrutton L.J has said “„Profession‟ in the present use of language involves the idea
of an occupation requiring either purely intellectual skill, or of manual skill controlled,
as in painting and sculpture; or surgery, by the intellectual skill of the operator, as
distinguished from an occupation which is substantially the production or sale of
commodities. The line of demarcation may vary from time to time. The word
„profession‟ used to be confined to the three learned professions, the Church,
Medicine and the Law. It has now, I think a wider meaning” 28

29
According to Rupert M Jackson and John N Powell, the occupations which are
regarded as professions have four characteristics
 Skilled and specialized nature of work.
 Commitment to moral principles.
 Professional association regulates standards of profession.
 High status in the community

Negligence
Negligence means: the omission to do something which a reasonable man, guided
by those ordinary considerations which ordinarily regulate human affairs, would do or
the doing something which a reasonable and prudent man would not do.

26
Rajyalaxmi Rao, CONSUMER IS KING, Universal Law Publishers; 3rd Edition; March 1, 2012;
pp.24
27
Ibid
28
Id. 15
29
Id. 15
11
Negligence as a tort is the breach of a duty caused by omission to do something
which a reasonable man would do or doing something which a prudent and
reasonable man would not do. The definition involves the following constituents: 30
 A legal duty to exercise due care;
 Breach of the duty; and
 Consequential damages

Professional Negligence
In the law of negligence, professionals such as lawyers, doctors, architects and
others are included in the category of persons professing some special skill or skilled
persons generally. Any task which is required to be performed with a special skill
would generally be admitted or undertaken to be performed only if the person
possesses the requisite skill for performing that task.

Professional Liability 31
In the matter of professional liability professions differ from other occupations for the
reason that professions operate in spheres where success cannot be achieved in
every case and very often success or failure depends upon factors beyond the
professional‟s control. Medical practitioners do not enjoy any immunity and they can
be sued in contract or tort on the ground that they have failed to exercise reasonable
skill and care. It would thus appear that medical practitioners, though belonging to
the medical profession, are not immune from a claim for damages on the ground of
negligence. The fact that they are governed by the Indian Medical Council Act, 1956
and are subject to the disciplinary Control of Medical Council of India and/or State
Medical Councils is no solace to the person who has suffered due to their negligence
and right of such person to seek redress is not affected.32

Medical Negligence
Negligence can be described as failure to take due care, as a result of which injury
ensues. Negligence excludes wrongful intention since they are mutually exclusive.
Carelessness is not culpable or a ground for legal liability except in those cases in

30
Id. 15
31
Id. 15
32
Id.28
12
which the law has imposed the duty of carefulness. The medical profession is one
such section of society on which such a duty has been imposed in the strictest
sense. It is not sufficient that the medical professional acted in good faith to the best
of his or her judgment and belief.

Duty of Care 33
As the proverbial saying goes that the worst case goes to the best profession, yet
even the best cannot be sure of success. Just as the best of a lawyer cannot be
presumed to give a guarantee to win, the best of a doctor is not presumed to have a
guarantee to cure. The duty owed by a medical professional to his patient has been
summed up by Lord Hewart, C.J in the following words:

“If a person holds himself out as possessing special skill and knowledge and he is
consulted, as possessing such skill and knowledge, by or on behalf of patient, he
owes a duty to the patient to use due caution in undertaking the treatment. If he
accepts the responsibility and undertakes the treatment and the patient submits to
his direction and treatment accordingly, he owes a duty to the patient to use
34
diligence, care, knowledge, skill and caution in administering the treatment”

Various Laws dealing with Medical Negligence in India include,

1. Law of Torts. 4. Constitutional Law.
2. Law of Contract. 5. Fatal accidents Act.1855
3. Criminal Law 6. Consumer Protection Act 1986.35

Laws dealing with Medical Negligence in India are represented in following diagram.

33
. Jagdish Singh&Vishwa Bhushan, 2007, Medical Negligence and Compensation, 3rd Edition, page
29.

34
. Id. at pp.30

35
. Figure 1
13
 36

Negligence is not susceptible to any precise definition as found by Indian Courts.

Various meanings may be attributed to negligence. It connotes careless state of
mind which may amount to recklessness or indifference. It is a careless conduct
without reference to any duty to take care. As it is pointed out by Hon‟ble Justice
Chagla, ACJ and Hon‟ble Justice Bhagavati J. the actions for negligence in India are
to be determined according to the principles of English common Law. 37

The essential components of the tort of negligence, as postulated by Percy and

38
Charlesworth are as follows
(a) the existence of duty to take care, which is owed by the defendant to the
complainant
(b) the failure to attain that standard of care, prescribed by law, thereby committing a
breach of such duty, and
(c) damage, which is both causally connected with such breach and recognized by
law, has been suffered by the complainant

36
. Poster presented by Researcher at Founding Conference of European Association of Health Law,
Edinburgh, UK 2008, See Annexure I
37
. R.K. Bag, LAW OF MEDICAL NEGLIGENCE AND COMPENSATION; Second edition 2003;
Eastern Law House, pp. 4.
38
. Id.

14
By applying the above principles, medical Negligence has been defined as, want of
reasonable care and skill of the part of medical practitioner that results in damage to
the patient. Before the application of Consumer Protection Act to the medical field,
the medical negligence cases used to be dealt under law of torts. After the
application of Consumer Protection Act, with plethora of case laws, various concepts
have been evolved which include medical negligence, reasonable skill and care,
damages due to negligence, importance of documentation, legally valid consents,
second opinion during the treatment of a complicated patient, skill updating by
specialist doctors and so on.39

The application of the Consumer Protection Act to the medical field in 1995 is a
milestone in the history of legislations for medical negligence. Since the application,
there has been a rise in the litigations against medical practitioners. There is also
increase in the vexatious complaints to gain the unhealthy mileage of the law. With
the plethora of case laws under Consumer Protection Act, various conceptions and
principles are being defined. Since the two fields, legal and medical, are different in
approach, there are likely to be lacunae in the concepts and implementation of the
Consumer Protection Act, which need to be addressed.

At one time it was thought that the state was mainly concerned with the maintenance
of law and order and the protection of life, liberty and property of the subject. Such a
restrictive role of the state is no longer a valid concept. Today living in an era of a
welfare state health is considered to be man's most valuable possession since all his
activities is influenced by the state of his health.

The Directive Principles of State Policy under the constitution of India require the
state to make effective provision for public health, and for just and humane
conditions of work. It is the primary duty of the State to raise the level of nutrition, the
standard of living of its people and the improvement of public health. 40 Articles 42 &
47 indicate that government had become conscious of this modern phenomenon and
this provision could serve the function of providing a constitutional footing for further
legislative and administrative actions. However, it is submitted that the constitutional

39
Id
40
Constitution of India. Art. 47
15
scheme for the protection of health, as originally envisaged, contained a serious
lacuna, which was later removed by judicial innovation. It may be appreciated that
Articles 42 and 47, which impose constitutional obligation on the State are, non-
justiciable in nature. It means if state fails to discharge its obligation, such failure
cannot be questioned in court of law and there is no judicial remedy. But this
anomaly has been removed by judicial creativity and innovation. The Supreme Court
of India's creativity expanded the contours of Article 21, so as to sub serve the right
of health and Medicare in it. Though, fundamental rights are negative rights and can
be invoked only when it has been violated without the due process of law. In
healthcare the damages are irreparable and cannot be brought back. So the court
took the positive step and interpreted this negative as positive right under Article
21of the Constitution of India.

In Paramanand Katara v. Union of India,41 Supreme Court has declared that right to
medical aid is an integral part of right to life. It is an obligation on the State to
preserve life by extending required medical assistance. In fact, the Apex court has
held that right to health and medical care is a fundamental right under the
Constitution of India.

Further, Supreme Court in Paschim Banga Khet Mazdoor Samiti v. State of WB42
has held that providing adequate medical facilities for the people is an essential part
of the obligation undertaken by the government in a welfare state. Article 21 imposes
an obligation on the State to safeguard the right to life of every person and on the
breach of which s/he can move the Supreme Court or High Court through writ
petition.43

41
. 1989 (4) SCC 286 : AIR 1989 SC2039:1989 ACJ 1000:1989 (4) SCC 286

42
. 1996 (4) Supreme 260 : AIR 1996 SC 2426 : 1996 (4) SCC 37: JT 1996(6)43(SC)

43
. Constitution of India. Art.32 and Art 226.

16
Practice of medicine as part of healthcare is capable of rendering great service to the
society provided due care, sincerity, efficiency and skill are observed by doctors.
Medical profession has its own ethical parameters and code of conduct.

Certain other factors are of great concern.

First is the standard and parameters for seeking admission to medical course has
changed with the change in society. Now the medical profession has degenerated
from its earlier service and humble motive, quite frequently the medical practitioners
are reportedly being involved in activities like organ sale racket.

Second is the hesitation of qualified doctors to take up rural assignment. These

assignments have become more of experience- gaining phenomenon and last resort
than the real motive for joining the profession.

Third is the large scale mushrooming of hospitals and nursing homes. The big
corporate hospitals having branches all over the country have given rise to strange
situation but in reality created a paradox. These phenomena have a cascading effect
and started to commercialize health services. On the other hand the patient is
developing an attitude of "shopping" with his disease. Consequently, the fourth thing
that has emerged and appears to be the most serious one, is, the accountability of
remedial action of the professionals in this noble vocation.

Today, the Patient-doctor relationship has almost diminished its fiduciary character.
'Services' of medical establishments are more of purchasable commodities and the
'business' attitude have given an impetus to more and more malpractices and
instances of neglect. But the question is, whether, on the whole, branding the entire
medical community as a delinquent community would serve any purpose or will it
cause damage to the patients. The answer is, no doubt, the latter.

It is not that measures to check such dereliction are absent. Victims of medical
negligence, considering action against an erring doctor, have three options.
 Compensatory mode - Seek financial compensation before the Consumer
Disputes Redressal Forum or before Civil Courts
 Punitive/Deterrent mode - Lodge a criminal complaint against the doctor
17
 Corrective/ Deterrent mode - Complaint to the State Medical Council demanding
that the doctor's license is revoked.

Jurisdiction of Civil Court was never disputed but its scope was limited to damages
only. Doctors were initially excluded from the ambit of the Consumer Protection Act,
when these courts were first set up in 1986. The Supreme Court's judgment, in
Indian Medical Association, v. V.P. Shantha and ors.44 , has brought them within its
purview. There are three tiers of dispute redressal fora. At the lowest level is the
District Consumer Disputes Redressal Forum (one in each district), which entertains
compensation claims up to Rs.20 Lakh. At the next level is the State Consumer
Disputes Redressal Forum (one in each state), where compensation claims between
Rs.20 Lakh and Rs. 1 Crore are made. At the National Forum, claims of over Rs. 1
Crore are lodged. Those dissatisfied with the judgment of the lower forum can
appeal to a higher forum. The final court of appeal is the Supreme Court.

Criminal cases against doctors are lodged mainly following the unnatural death of a
patient under their care. The section employed is usually 304 of the Indian Penal
Code for a rash or negligent act not amounting to culpable homicide and carries
maximum imprisonment of two years, or a fine, or both.

Following the recent Supreme Court judgment in Suresh Gupta v. Govt. of NCT of
Delhi,45 however, criminal cases against doctors are likely to register a steep fall.
The police will have to be first provide proof of "recklessness and deliberate
wrongdoing" on the doctor's part.

Further a complaint can also be lodged with Medical Council of India together with
State Medical Councils seeking cancellation of the doctor‟s license. It is the Medical
Council which gives doctors their license to practice; the license can be withdrawn if
the doctor is found guilty of misdemeanours. On past experience it can be said that

44
. AIR 1996 SC 550 : 1995 (6) SCC 651 :1995(3) CPJ 1(SC) : 1995(3) CPR 412 (SC)

45
. 2004 (6) SCC 422

18
the chances of the Medical Council taking any such step, 46 are slender except in
certain cases. Recently, the Delhi High Court has upheld the suspension of the
license of a city surgeon by the Medical Council of India. Dr. M.M. Bagati, who was
not a qualified paediatrician, had administered high dosage of drugs to an infant after
which the child developed renal problem. On enquiry doctor was found negligent and
Medical Council of India suspended his license for a year. When the doctor moved
High Court, upholding the Medical Council of India's decision, Justice Sanjay Kishan
Kaul held that "A professional doctor is required to prescribe what is required to be
done, including the investigation. Considering all facts, it is apparent that the doctor's
conduct is in the category of infamous conduct with respect to medical profession.
However, not a single doctor anywhere in India has ever since independence had his
license permanently revoked.47

Thus it can be said that in spite of remedy under different laws, the patients of
medical negligence are still suffering and they need additional protection especially
the patient from the Government Hospitals. Consumer Laws can be a great help
provided the consumers should be aware of their rights.

“It would not be correct to say that every moral obligation involves a legal duty; but
every legal duty is founded on a moral obligation. “Said Lord Chief Justice Coleridge.
48
No greater opportunity, no greater responsibility, and no greater obligation befall to
a person who chooses to become a medical doctor. In the care of the suffering
he/she needs scientific knowledge, technical skill and human understanding, and
those who use these with courage, with humility and with wisdom, provide a unique
service to their fellow men and women and build an enduring edifice of character
within them. This nature of service gives medicine its unique status of being a noble
profession. The bringing of medical services within the purview of the Consumer
Protection Act has caused a plethora of suits being filed in consumer forums against
imaginary and sometimes real negligence of doctors. „Consumerism‟ once

46
. Vandana Singh, High Court burns down doctor‟s pleas, Hindustan Times, New Delhi, Aug 17
2004, From “Medical Negligence and Our Laws-An Overview”.

47
. Vandana Singh, Medical Negligence and Our Laws-An Overview, Article.
www.cccindia.co/corecentre/Database/Docs/DocFiles/Article60.pdf accessed on April. 20, 2012
48
R v Instan (1893) 1 Qb at 453

19
unthinkable of as a term in medical parlance has been referred to now in the
Supreme Court judgment. The developed countries jargon of „producers and
consumers‟ have also been referred to in relation to the once sacred doctor patient
relationship. The once noble profession has been put at par with any sundry trade.49

Medical negligence has been defined as want of reasonable degree of care and skill
or wilful negligence on the part of the medical practitioners in the treatment of a
patient with whom the relationship of a professional attendant is established so as to
lead to his/her bodily injury or permanent disability or loss of life. The law on the
subject is very considerate to the medical profession. In Hatcher v Black50 , Lord
Daniel opined that the jury must not find a doctor negligent simply because one of
the risks inherent in an operation actually took place or as a matter of opinion he
made an error of judgment. They should find him guilty only when he had fallen short
of reasonable medical care.

Lord Justice Dealing observed that one should be doing disservice to the community
at large, if one were to impose liability on hospitals and doctors for everything that
happens to go wrong…..one must insist on due care for the patient at every point,
51
but we must not condemn as negligence that which is only a misadventure.

Mr. Justice Barrie in Moore v Levi sham Group52 observed that, “ when there are two
responsible schools of thought about the management of clinical situation, those
Courts could do no greater disservice to the society or to the advancement of
medical science than to place the hallmark of legality upon one form of treatment.

As observed by Lord Nathan53, a mistaken diagnosis is not necessarily a negligent

diagnosis. In Mitchell v. Dickson54Innes, ACJ observed,” no human being is infallible
and in the present state of science even the most eminent specialist may be at fault
in detecting the true nature of the diseased condition. A practitioner can only be

49
Nagpal Neeraj, Supra
50
Lancet 154-2-880
51
Roe v Ministry of Health, 1954-2-All E.R. 131

52
HMC (1959)
53
Medical Negligence, http://goodhealthnyou.com/library/reading/mpcpa/Chap7.asp , accessed on
May, 10, 2013
54
1954-AP PD-519
20
liable in this respect if his diagnosis is so palpably wrong as to prove negligence, that
is to say, if his mistake is of such nature as to imply absence of reasonable degree of
skill and care on his part, regard being had to the ordinary level of skill in the
practitioner.”

The standard of care which is required from the medical practitioners as laid down by
McNair, J. in his direction to the jury in Bolam v Friern Hospital Management
Committee55has been accepted by the House of Lords in a number of cases “But
where you get a situation which involves the use of some special skill or
competence, then the test as to whether there has been negligence or not is not the
test of man on the top of a Clapham omnibus, because he has not got this special
skill. The test is the standard of ordinary skilled man exercising and professing to
have special skill. A man need not possess the highest expert skill; it is well
established law that it is sufficient if he exercises the ordinary skill of an ordinary
competent man exercising that art”.

The Bolam case summary is as follows,

In this case the plaintiff, John Bolam, was a psychiatric patient suffering depressive
illness. He was advised by Dr de Bastarrechea, a consultant psychiatrist attached
to Friern Hospital, to undergo electro-convulsive therapy (E.C.T.). He signed a
consent form but was not warned about the risk of fracture that can occur because of
fit-like convulsions that such treatment induces. In due course, he received this
treatment but was not given any relaxant drugs. As a consequence, he suffered
several injuries. These included dislocation of hip joints and fractures to the pelvis on
both sides caused by the femur on both sides being driven through the cup of the
pelvis. The plaintiff claimed that the doctor was negligent in not giving him relaxant
drugs. By not doing so, the doctor also failed to provide adequate physical restraints
to prevent the injury. He also claimed that the doctor had failed to warn him of the
risks involved in the treatment. The judge, however, found the doctor not guilty of
negligence as he had acted in accordance with a practice accepted as proper by a
responsible body of medical men skilled in that particular area. Expert witness called
by either side gave evidence as to the different techniques which they adopted in

55
Bolam v Friern Hospital Management Committee (1957) 2 All ER 118;1957, 1 WLR 582

21
giving E.C.T treatment; some used relaxant drugs, some used restraining sheets and
some used manual control, but all agreed that there was a firm body of medical
specialists who opposed to the use of relaxant drugs.

56
In an action for negligence in tort against a surgeon, the Supreme Court Held “The
duties which a doctor owes to his patient are clear. A person who holds himself out
ready to give medical advice and treatment impliedly undertakes that he is
possessed of skill and knowledge for the purpose. Such a person when consulted by
a patient owes him certain duties, viz., a duty of care in deciding whether to
undertake the case, a duty of care in deciding what treatment to give or duty of care
in administration of that treatment. A breach of any of those duties gives right of
action for negligence to the patient.”

Before the enforcement of the Consumer Protection Act, the field of medical
negligence was inevitably governed only by law of Torts. The precise definition of
negligence is perhaps not possible and it would remain a somewhat slippery word.
The classic attempted judicial definitions of negligence may be noticed from the
authoritative treatise of Salmond 57 as under.

“Negligence in the objective sense that is in the well known definition of Alderson B.
“the omission to do something which a reasonable man, guided by those
considerations which ordinarily regulate the conduct of human affairs, would do, or
doing something which a prudent and reasonable man would not do.”

The law relating to medical negligence finds its genesis in the common law principle
of negligence and was further developed by the judicial pronouncements in the
western world. In India also the legal development took place similarly since one of
the first reported judgments in a case of medical negligence dates back to 1969, i.e.,
case of Laxman Balkrishna Joshi v Triambak Bapu Godbole58, wherein the Hon‟ble
Supreme Court of India dealt in detail about the principles involved in medical
negligence and further elaborated the duties of doctors and also the patients.

56
1969(1) SCR 206
57
Salmond, LAW OF TORTS, Sweet & Maxwell; 21st Revised edition (24 Oct 1996)
58
1968 ACJ 183 (SC): AIR 1969 SC 128: 1969 (1) SCR 206

22
Madras High Court had taken a different view about the application of consumer
concept to the medical field. It was held that the services rendered to a patient by a
medical practitioner or by a hospital by way of diagnosis and treatment, both
medicinal and surgical, would not come within the definition of „service‟ under section
2(1) (0) Of the Consumer Protection Act and the patient cannot be considered to be
a consumer within the meaning of Section 2(1) (d) of the same Act.59

The Supreme Court put forth a number of conclusions in the historical judgment, in
60
Indian Medical Association v V.P.Shantha & Ors. While applying the Consumer
Protection Act to the medical profession,
 Service rendered to a patient by a medical practitioner would fall within the ambit
of „service‟ as defined in section 2(1)(o) of the CPA.
 The service rendered by a medical practitioner to be considered to a contract for
personal service and that comes within the purview of the CPA
 Services rendered free of charge would not attract the provisions of this Act.

Deficiency 61
According to Section 2(l) (g) of the CPA, 'deficiency' means any fault, imperfection,
shortcoming, or inadequacy in the quality, nature, and manner of performance which
is required to be maintained, by or under any law for the time being in force, or has
been undertaken to be performed by a person, in pursuance of a contract or otherwise,
in relation to any service.

In the context of the medical profession, deficiency means that the treatment provided
by the medical practitioner is not correct or not according to accepted medical
standards. Deficiency of service may also include treatment by using faulty instruments,
lack of ICU or ambulance services, etc. Deficiency of service under the CPA is almost
equal to medical negligence under the law of torts. There can be deficiency of service
even without any harm or injury to the patient. For example, refusal to give treatment record

59
Dr. C.S.Subramanian v Kumarswamy & Anr. (1994) 1 MLJ 438
60
AIR 1996 SC 550: 1995 (6) SCC 651:1995(3) CPJ 1(SC): 1995(3) CPR 412(SC)
61 st
Tapas Kumar Koley,MEDICAL NEGLIGENCE AND THE LAW IN INDIA: INTRODUCTION,1
edition,Oxford University Press,2010, pp.139-141
23
or payment receipt by the medical professional or healthcare institution may be considered
as deficiency of service.62

Service
According to Section 2(l)(o) of CPA, 'service' means service of any description which is
made available to potential users and includes, but not limited to, the provision of
facilities in connection with banking, financing, insurance, transport, processing, supply
of electrical or other energy, board or lodging or both, housing construction,
entertainment, amusement or the purveying of news or other information, but does not
include the rendering of any service free of charge or under a contract of personal service.

Therefore now in the medical profession, treatment given by a medical professional or

health care institution will be considered service under the Act. Besides medical care, other
services provided for patients like ambulance services, are also included in this definition.
Almost all types of service that a patient gets, right from getting inside the hospital tills
he/she leaves the hospital, are considered service and any shortcoming in this regard will"
be considered deficiency of service. The negligence of medical professionals comes
within the definition of deficiency in service.

In the IMA case, the Supreme Court held,

The definition of services in Section 2(1) (o) of the Act can be split up into three parts - the
main part, the inclusionary part and the exclusionary part. The main part is explanatory in
nature and defines service to mean service of any description which is made available to
the potential users. The inclusionary part expressly includes the provision of facilities in
connection with banking, financing, insurance, transport, processing, supply of electrical or
other energy, board or lodging or both housing construction, entertainment, amusement
or the purveying of news or other information. The exclusionary part excludes rendering of
any service free of charge or under a contract of personal services. The inclusive part of
the definition of 'service' is not applicable and one is required to deal with the questions
failing for consideration in the light of the main part and the exclusionary part of the
definition. The exclusionary part will require consideration only if it is found that in the
matter of consultation, diagnosis and treatment a medical practitioner or a
hospital/nursing home renders a service falling within the main part of the definition

62
Id.
24
contained in Section 2(l)(o) of the Act. One has, therefore, to determine whether medical
practitioners and hospitals/ nursing homes can be regarded as rendering a "service" as
contemplated in the main part of Section 2(1) (o).63

The Learned Judges concluded in IMA case as follows.64

(1) Service rendered to a patient by a medical practitioner (except where the doctor
renders service free of charge to every patient or under a contract of personal
service), by way of consultation, diagnosis and treatment, both medicinal and
surgical, would fall within the ambit of 'service' as defined in Section 2(1) (o) of the
Act.
(2) The fact that medical practitioners belong to the medical profession and are
subject to the disciplinary control of the Medical Council of India and/or State Medical
Councils constituted under the provisions of the Indian Medical Council Act would
not exclude the services rendered by them from the ambit of the Act.
(3) A 'contract of personal service' has to be distinguished from a 'contract for
personal services'. In the absence of a relationship of master and servant between
the patient and medical practitioner, the service rendered by a medical practitioner to
the patient cannot be regarded as service rendered under a 'contract of personal
service'. Such service is service rendered under a `contract for personal services'
and is not covered by exclusionary clause of the definition of 'service' contained in
Section 2(1) (o) of the Act.
(4) The expression 'contract of personal service' in Section 2(1) (o) of the Act cannot
be confined to contracts for employment of domestic servants only and the said
expression would include the employment of a medical officer for the purpose of
rendering medical service to the employer. The service rendered by a medical officer
to his employer under the contract of employment would be outside the purview of
'service' as defined in Section 2(1) (o) of the Act.

(5) Service rendered free of charge by a medical practitioner attached to a

hospital/Nursing home or a medical officer employed in a hospital/Nursing home
where such services are rendered free of charge to everybody, would not be
63
AIR 1996 SC 550, para. 17.
64
Indian Kanoon - http://indiankanoon.org/doc/723973/

25
"service" as defined in Section 2(1) (o) of the Act. The payment of a token amount
for registration purpose only at the hospital/nursing home would not alter the
position.
(6) Service rendered at a non-Government hospital/Nursing home where no charge
whatsoever is made from any person availing the service and all patients (rich and
poor) are given free service - is outside the purview of the expression 'service' as
defined in Section 2(1) (o) of the Act. The payment of a token amount for registration
purpose only at the hospital/Nursing home would not alter the position.
(7) Service rendered at a non-Government hospital/Nursing home where charges
are required to be paid by the persons availing such services falls within the purview
of the expression 'service' as defined in Section 2(1) (o) of the Act.
(8) Service rendered at a non-Government hospital/Nursing home where charges
are required to be paid by persons who are in a position to pay and persons who
cannot afford to pay are rendered service free of charge would fall within the ambit of
the expression 'service' as defined in Section 2(1) (o) of the Act irrespective of the
fact that the service is rendered free of charge to persons who are not in a position to
pay for such services.
Free service, would also be "service" and the recipient a "consumer" under the Act.
(9) Service rendered at a Government hospital/health centre/dispensary where no
charge whatsoever is made from any person availing the services and all patients
(rich and poor) are given free service - is outside the purview of the expression
'service' as defined in Section 2(1) (o) of the Act. The payment of a token amount for
registration purpose only at the hospital/nursing home would not alter the position.
(10) Service rendered at a Government hospital/health centre/dispensary where
services are rendered on payment of charges and also rendered free of charge to
other persons availing such services would fall within the ambit of the expression
'service' as defined in Section 2(1) (o) of the Act irrespective of the fact that the
service is rendered free of charge to persons who do not pay for such service. Free
service would also be "service" and the recipient a "consumer" under the Act.
(11) Service rendered by a medical practitioner or hospital/nursing home cannot be
regarded as service rendered free of charge, if the person availing the service has
taken an insurance policy for medical care where under the charges for consultation,
diagnosis and medical treatment are borne by the insurance company and such

26
service would fall within the ambit of 'service' as defined in Section 2(1) (o) of the
Act.
(12) Similarly, where, as a part of the conditions of service, the employer bears the
expenses of medical treatment of an employee and his family members dependent
on him, the service rendered to such an employee and his family members by a
medical practitioner or a hospital/nursing home would not be free of charge and
would constitute 'service' under Section 2(1) (o) of the Act.65

Inclusion of Medical Services under the CPA

This is probably the most significant issue that was clarified by the Supreme Court in the IMA
case. It removed all confusions prevailing initially regarding the inclusion of medical
services under the purview of the Act. All types of medical services were brought under the
purview of CPA.

The Supreme Court observed that medical practice is a profession rather than an
occupation and medical professionals provide a service to the patients and thus they are
not immune to the claim from damages on the ground of negligence. From this viewpoint
the Court concluded that a patient can be a 'consumer' for the purpose of CPA. Besides
this, the Court also observed that consumer protection was very well established in both
the UK and the USA in the field of medical practice. The Supreme Court referred to the
well-known book Law and Medical Ethics, by Mason and McCall Smith,66and Arizona v.
Maricopa County Medical Society,67 which is the leading case on price fixing in the health
care industry. In that case it was held that the fixing of maximum prices for insured users of
medical services constituted per se illegal price fixing under Section 1 of the Sherman
Antitrust Act (1890). Considering all these facts the Supreme Court concluded as follows;

We are, therefore, unable to subscribe to the view that merely because medical
practitioners belong to the medical profession they are outside the purview of the
provisions of the Act and the services rendered by medical practitioners are not covered
by Section 2(l)(o) of the Act. 68

65
Id
66
Fourth edition
67
IMA case, para. 26
68
IMA case, para. 26
27
After this judgment, majority of medical negligence cases in India are filed in consumer
courts under the Act. The Indian Medical Association had put forward many arguments
in its attempt to persuade the Court that doctors should not be brought under the purview
of the CPA. All the arguments were taken up by the Court and clear rulings were given.

In the case of Vinitha Ashok V Laxmi Hospital &Ors 69 , within the consumer
jurisdiction the matter was summed up in the following terms “ …..it is clear that the
law does not require that a doctor in the discharge of his duty of care should use the
highest degree of skill since they may never be acquired. It is enough for the doctor
to show that he acted in accordance with the general and approved practice…..”

In another case in the consumer jurisdiction, Justice Shah opined that, “in any
treatment it is never claimed by the medical profession that every person who
receives the treatment must and should be benefited by the same because the
benefit of a particular type of system or operation or medicine depends upon a
number of factors…..”70

Since the application of the Consumer Protection Act to the medical field, a number
of legal principles have been postulated in various judgments by the consumer
courts. The legal system has so far shown remarkable maturity in dealing with
complicated technical issues based on expert opinion, standard textbook reference
and other evidence. The Court has held that all complaints being brought about
deficiency in service based on the ground of negligence in rendering medical
services, do not involve complicated questions requiring of evidence of experts. It is
now presumed that intricate technical questions of medical negligence requiring
expert witnesses to be summoned and cross-examination conducted would have to
be referred to civil courts. In the case of Bhavchandbhai Manjibhai Lakhani v
71
Dr.Bhupendra D Sagar, the consumer forum has, with help of expert witness
cross-examination, held a medical practitioner negligent.

69
. AIR 2001 SC 3914: 2001 (8) JT 142: 2001(4) Supreme 225: 2001(6) SLT 735
70
.Shri Ram Singh Parmar v Mr.Sampat Raj C Shah & Anr, 1993 (2) CPR 496 (Guj. SCDRC)
71
. Complaint no.378 of 1991, decided on 26-8-1993 (Guj. SCDRC) Unreported
28
From the analysis of the literature it is observed that, there is no comprehensive
empirical study or any triangular study on the application of CPA on doctors. There
has not been any analytical or comparative study or any local study on the trends
emerging out of inclusion of doctors in CPA. Critical evaluation on any variable or
influencing factor also does not exist. Therefore, there is a need to conduct a
thorough research in order to locate these trends at the local, state and national
level. Further, there is a need to assess the response of the professionals and the
changing nature of doctor-patient relationship in post-CPA period. Moreover, the
resistance of IMC also requires to be put in context.

Further, the researcher has a personal pain area of being a litigant and also has
observed the ignorance of medical professionals about the working of this law. Thus,
the research on trends and changing trends with reference to Medical negligence is
designed.

Trend

A „trend‟ can be defined by various ways; the accepted definitions of the trend are as
follows:
72
1. A general direction in which something is developing or changing.
2. A gradual change or development that produces result.73
3. A general tendency in the way a situation is changing or developing74
4. A pattern of gradual change ina condition, output,or process,oran average or gen
eral tendencyofa series of data points to move in a certain direction over time,
represented by a line or curve on a graph.75

The study of changes taking place after the application of the Consumer Protection
Act to the Medical Field , will define the trend in this particular „Law” and thus being
studied by the researcher.

Law

72
Available at http://oxforddictionaries.com/definition/english/trend
73
Available at http://www.macmillandictionary.com/dictionary/british/trend
74
Available at http://www.ldoceonline.com/dictionary/trend
75
Available at http://www.businessdictionary.com/definition/trend.html#ixzz2LokXsx1G
29
In order to define and study the trends in the “Law” of Medical Negligence under
Consumer Protection Act, the term law means:
1. [mass noun] (often the law) the system of rules which a particular country or
community recognizes as regulating the actions of its members and which it may
enforce by the imposition of penalties:76
2. The principles and regulations established in a community by some authority and
applicable to itspeople, whether in the form of legislation or of custom and policie
s recognized and enforced by judicial decision.77

Though there is no exact “Law of Medical Negligence”, the laws Governing Medical
Negligence like Law of Torts, Criminal Law and Consumer Law has been taken as
laws of medical negligence. With these concepts fixed as the basis for the
framework, the following objectives are identified.

1.4. Objectives
To study the concept of the Law of Medical Negligence, the objectives of this
study can be defined as follows-

1. To study the concept of medical Negligence as a whole under various Indian

laws, including case laws and legislation, inter alia, decisions of Medical Councils
related to the cases of Medical Negligence, Law of Torts, Criminal law, law of
Contract, Medical council Act and Consumer Protection Act.
2. To identify and analyze the Changing Trends in the Law of Medical Negligence in
India and its impact.
3. To study the comparative position of the law in this regard with reference to
foreign laws, to explore the linkages with the International approach towards
Medical Negligence.

76
Available at http://oxforddictionaries.com/definition/english/law
77
Available at http://dictionary.reference.com/browse/law
30
1.5 Research Questions
1. How is the Concept of Medical Negligence defined under various laws in India
and abroad?
2. What are the various trends visible in the approach towards Medical Negligence
in India and abroad?
3. What are the parameters of Consumer Protection that determine the nexus
between Medical Negligence and its consequences under Consumer Protection
Act? Should the Consumer Protection Act continue to govern it in India?

1.6 Scope of the Study

The concept of medical Negligence has been studied as a whole under various
Indian Laws; Law of Torts, Criminal law, law of Contract, Medical council Act and
Consumer Protection Act The judgments of various case laws under the Consumer
Protection Act are studied from the beginning up to March 2013 combining local
trends in Pune and aligning them with state and national trends. The current and
Changing Trends in the law of Medical Negligence under various laws and foreign
laws are observed and postulate to predict the further changes. The study and
evaluation of the lacunae in the Consumer Protection Act and its implementation,
have guided the corrective measures that can be recommended. The study of
International approach towards the Medical Negligence provided, by studying foreign
case laws, thus locating International Trends in the Medical Negligence.

1.7 Methodology
This mixed methods study has addressed the, “Changing Trends in the law of
Medical Negligence under Consumer Protection Act 1986”. A triangulation; Mixed
78
Methods Design: Convergence Variant was used, a type of design in which
different but complementary Data are collected on the same topic. This is the

78
John Creswell, Vicky L.Plano Clark, DESIGNING AND CONDUCTING MIXED METHODS
RESEARCH, Sage Publications,2007, Pp. 64
31
combination of the result of more than two rigorous approaches conducted to provide
79
a more comprehensive picture of the results than either approach could do alone.

In this study, the Quantitative Instruments, through 31 identified variables that affect
the concept of Medical Negligence are used to establish the Theory of Changing
Trends in the Law of Medical Negligence. There is an analysis of case laws of
Supreme Court obtained as doctrinal data, the decided cases from National
Commission from its website as well as MCI Guidelines and Bill as primary data and
locally-generated 10 selective cases of Pune appealed at the State Commission as
primary data are analyzed and are finally compared.

Also, there is a pure empirical data based component that studies the perception of
the affected sections of Society, i.e., the Doctors, Hospital Administrators and
Community members in Pune by tool of questionnaires.

Questionnaire for 427 Doctors, Specialists, Super specialists and 41 Hospital

Administrators from Pune and Questionnaire for 428 Community Members from
Pune80

Further, structured schedule was used as a tool to Interview experts such as Prof
81
Graeme Laurie of Edinburgh Law School, Scotland.UK , along with 24 doctors,
Specialists and 20 community members.82

The tools for the research are the ones used to collect data for both the Doctrinal
and Empirical research.

Tools for Doctrinal Research: The case laws decided at Supreme Court available
at http://judis.nic.in and National Commission available at the website of National
Commission www.confonet.in and various books available.

79
Abbas Tashakkori&Charles Teddlie, PRINCIPLES OF MIXED METHODS AND MULTIMETHOD
RESEARCH DESIGN,2003 edition; HANDBOOK OF MIXED METHODS IN SOCIAL AND
BEHAVIOURAL RESEARCH, 2003edition, pp.190.
80
Annexure V
81
See Annexure VII
82
See Annexure, V
32
The case laws were analyzed for 31 variables and their interrelationships.83

Tools for Empirical Research included the following:

a. Questionnaire for Awareness of Doctors
b. Questionnaire for Awareness of Community
c. Questionnaire for Awareness of Hospital Administrators
d. Interview Schedule for Judges and Medical Law Experts
e. Case Studies 10 from Pune District Forum that are in Appeal at State Consumer
Redressal Commission, Mumbai.

Concurrently, Qualitative methods are used in Surveys of Doctors, Hospital

Administrators and Community; and Case laws including 10 cases from Pune District
Consumer Forum that approached State and National Commission are used to
explore the Changing Trends in the Law of Medical Negligence. The reason for
collecting both quantitative and qualitative data is to bring together the strengths of
both forms of research to corroborate results.

This Convergence study has defined what similarities and the differences exist
across levels of analysis. The study was a concurrent one and was conducted in a
Single phase. During the study, an attempt was made, to assess different aspects of
reasoning that led to the postulations of various legal principles applied under the
Consumer Protection Act.

The researcher has specifically studied foreign case laws on Medical Negligence, in
order to compare the similarities and differences. The comparative study of all the
case laws is being utilized to evaluate the changing trends in the law of medical
negligence.
 Study of Indian and Foreign scenario
 Study of MCI guidelines

83
See Annexure VI
33
 Further, diagrammatic overview of the methodology follows:

Triangulation design

QUAN QUAL

Interpretation based on
QUAN + QUAL results

Triangulation Design: Convergence model

QUAN QUAN
QUAN
data data
results
collection Analysis

Compare and Interpretation

Contrast QUAN + QUAL

QUAL
QUAL
data QUAL
data
collectio results
Analysis
n

Creswell John W, Clark Vicky L Plano, 2007, Designing and Conducting mixed methods
Research, Sage Publications , P63

Figure 2

34
Visual Diagram: Diagrammatical Representation of Methodology

Library
Study

Case Law Analysis Analysis of Legislations and MCI

Doctrinal
Method

Analysis
Changing
Trends in
Triangulation
law of
Medical
Negligence
Analysis

Empirical
method

Interviews Case Surveys

studies

Doctors, 10 Pune Doctors,

Community, Cases in Community
Experts state and
National
Commission

Figure 3

35
Details

A: Doctrinal Study
Variables for Quantitative Analysis of Case Laws were designed and developed after
thorough conceptualization and theoretical study on medical negligence laws.
Sample
The study sample consisted of 40 case laws of Supreme Court and 300 case laws of
the National Consumer Disputes Redressal Commission (hereinafter National
Commission) from its inception till March 2013. The cases were selected from the
web sources, www.judis.nic.in and www.confonet.in based on the cause of action-
”Medical Negligence”. The method for the cases section was Purposive sampling, as
by March 2013, the number of cases available from Supreme Court was 40 from all
available resources. Similarly the total number of cases available from National
Commission was 300 from all available resources. So these sample Case laws
selected belong to Universal data. Total Universe of Medical Negligence Case law
data available till March 2013 was studied for the purpose of research.

Development of variables
After studying the case laws, 31 variables were developed. These are developed by
reading and analyzing various concepts from the articles on the topic. The variables
are based on the relationship of various factors with the Medical Negligence. Coding
was planned and coding was done for all the variables for the samples selected from
case laws. Statistical analysis was done after the coding of all the case laws.

Validity
Validity means the researcher can draw meaningful inferences from the results to a
population.

Reliability
Reliability means that scores received from participants are consistent and stable
over time.84

84
Abbas Tashakkori &Charles Teddlie, PRINCIPLES OF MIXED METHODS AND MULTIMETHOD
RESEARCH DESIGN,2003 edition; HANDBOOK OF MIXED METHODS IN SOCIAL AND
BEHAVIOURAL RESEARCH, 2003edition, pp.190.and after discussion with Dr.K.P.Suresh, Scientist
(Biostatistics), Project Directorate on Animal Disease Monitoring and Surveillance, Bangalore-560024

36
B: Empirical Study

Design and Development of scale: Sample

The study sample consisted of 427 doctors, 41 hospital administrators and 428
Community members constituted the random sample. Three scales were designed
to collect the information related to the construct “Concept of Medical Negligence
defined under various laws in India and abroad”

Broad themes explored in the Questions for doctors and Hospital Administrators are
as follows,
 Awareness about CPA
 Awareness about Trend Setting Cases
 Knowledge of Concepts of Medical Negligence and Deficiency in Service
 Knowledge of Bolam and Bolitho Principles
 Awareness of MCI Regulations
 Legal Concepts of Valid Consent, Prior Informed Concept and Doctor Patient
Relationship
 Knowledge of Professional Indemnity Insurance
 Knowledge the concepts of Evidence Based Medicine, Treatment Protocols
 Knowledge Concepts of Vicarious Liability, Second Opinion and Documentation
 Personal Opinion about applicability of CPA to Medical Field , Impact of CPA and
Alternatives

Broad themes explored in the Community Questionnaire are as follows,

 Awareness about CPA
 Own Experience about Medical Treatment
 Opinion about the applicability of CPA to doctors
 Impact of CPA on Doctors and Doctor Patient Relationship
 Trust in Doctors and Need of Second Opinion.

37
Technique and Procedure
The objective of developing a scale is to create a valid measure of an underlying
construct. The theoretical principles, practical issues, and pragmatic decisions must
be considered in construct validity of scales and the subscales. It is essential to
conceptualize on the content of the scale and the initial item pool should include
items representing all the subsections of the scale, if any.

The method of wording the content and formulation of the statements need careful
attention. The item pool should be later tested, along with variables and the
objectives of the study to assess closely related constructs, on a heterogeneous
sample representing the entire range of the target population.85 Finally, in selecting
scale items, the goal is uni-dimensionality rather than internal consistency; this
means that virtually all inter -item correlations should be moderate in magnitude.

Validity: It is the most important consideration when developing, evaluating and

interpreting tests. It refers to the appropriateness, meaningfulness, and usefulness of
the specific inferences researchers make based on the data they collect. Validity has
been described as 'the agreement between a test score or measure and the quality it
is believed to measure' 86 .It is the most important step to be considered when
preparing or selecting an instrument for research study and the degree to which
evidence and theory support the interpretations of test scores entailed by the
proposed test.

Creation of item pool and face validity:

Once the objectives and the content domain were tentatively identified, the task of
formulating the items /questions for the scale was completed. The formulation of the
initial pool of items related to the various domains is a crucial task for developing the
scale. The fundamental goal at this juncture is to formulate all content systematically
in a sequential manner that is potentially relevant to the target construct. The

85
Suresh K.P. and Chandrasekhar S (2012).Sample Size estimation and Power analysis for Clinical
research studies. Journal Human Reproduction Science,5(1), 7-13.

86 th
Bernard Rosner (2000), Fundamentals of Biostatistics, 5 Edition, Duxbury, page 80-240 ;Kaplan
and Jacuzzi, 2001

38
importance of the initial literature review becomes quite obvious in this process.
Loevinger (1957) offered the classic articulation of this process: "The items of the
pool should be chosen so as to sample all possible contents which might comprise
the putative trait according to all known alternative theories of the trait ".

For the present study the items / questions reviewed from books, journals and
electronic media were identified, adapted and compiled in framing of 100 items for
doctors and administrators and 20 items for community members that covered the
aspects of Concept of Medical Negligence defined under various laws in India and
abroad” on a five -points Likert scale – 1: Strongly disagree, 2: Disagree, 3: Neutral,
4: Agree and 5: Strongly agree.

Content Validity: Content Validity is based on the extent to which a measurement

reflects the specific intended domain of content87. It refers to the conceptualization of
the statements for developing the scale for the study. If the researcher has focused
in too closely on only one type or narrow dimension of a construct or concept, then it
is conceivable that other indicators are overlooked. In such a case, the study lacks
content validity. An estimate of content validity of a test88 is obtained by thoroughly
and systematically examining the test items to determine the extent to which they
reflect and do not reflect the content domain.

For the present study, the individual statement was drawn from a large pool of items
that covered Concept of Medical Negligence defined under various laws in India and
abroad. The developed scale was assessed for both face and content validity by a
panel of experts from the field of Medical professionals, Community and Hospital
administrators. All the items pooled were subjected to face, screened to have 70 for
Doctors and Administrators and 15 for Community members. The scales of 70 items

87
Robert H Riffenburg (2005), STATISTICS IN MEDICINE, second edition, Academic press. 85-
125;Carmines & Zeller, 1991

88
Griner PF, Mayewski RJ, Mushlin AI, Greenland P (1981) SELECTION AND INTERPRETATION
OF DIAGNOSTIC TESTS AND PROCEDURES., Annals of Internal Medicine, 94, 555-600

39
and 15 items respectively were further subjected to content validity with 3 panels of
experts. The experts were requested to score each item in scale as 1 for not relevant
and 10 for not relevant in a 10- point scale. The Scoring pattern obtained by experts
analyzed using the AIKEN`s Index. The items which satisfied Aiken`s Index more
than 0.70 were included in the scale otherwise it removed. The following procedure
in eight steps of Aiken`s V index for content validity are as follows.89
 n experts rate the degree to which the item taps an objective on a 1 to c on
Likert-scale, where c is the maximum score in grading scale
 Let lo = the lowest possible validity rating (usually, this is 1 on the Likert-scale)
 Let r = the rating by an expert
 Let s = r – lo
 Let S = the sum of s for the n raters
 Aiken‟s V is then V = S / [n*(c-1)]

Construct validity is done with evidence that the test measures what it purports to
measure as well as evidence that the test does not measure irrelevant attributes are
both required.

Readability Test: For the present study, 57 items for Doctors/Administrators and 10
items for community items were formulated for studying the Concept of Medical
Negligence defined under various laws in India and abroad. After the tool was
developed, a draft copy of the tool was prepared and was tested for readability by
the investigator so as to ensure that the items of the tool did not have double barrel
questions, the items were not contradicting in nature and also further to ensure that
there was no repetition of any items with similar meanings.

Reliability is the extent to which a test or procedure produces similar results under
constant conditions on all occasions. For the present study, test- retest method was
used to assess the reliability of the instruments. The following reliability test was
carried out to estimate the reliability.

89
Sunder Rao P S S , Richard J(2006) : AN INTRODUCTION TO BIOSTATISTICS, A MANUAL FOR
th
STUDENTS IN HEALTH SCIENCES , New Delhi: Prentice hall of India. 4 edition, 86-160; Aiken,
1980

40
Pilot Study
A pilot study was conducted on sub sample of 50 doctors and hospital
administrators; and 50 community members. The Pilot study ensured that the items
in the scales were made easy, understandable by respondents, flexible for
administration of scale; the reliability measure such as Spilt-half reliability was
performed to know the reliability of scales and Cron bach Alpha was also performed
on the pilot study results to find the uni-dimensionality of scales.

The scale for measuring the Concept of Medical Negligence defined under various
laws in India and abroad for doctors and administrators consisted of 57 and 10 items
for community members finally constructed after meeting criteria of face validity,
Content validity and reliability measures. Scales were subjected to Pilot study with
sample of 50 doctors/administrators and 50 community members for measuring the
spilt-half reliability. The Spilt-half reliability measures shown that, Scale for
doctors/administrators has reliability co-efficient of 0.869 and 0.804 respectively
and for community it was 0.82. The Cron bach alpha for consistency and uni-
dimensionality were 0.806 and 0.791 respectively for the scale of doctors and
administrators and 0.911 for the scale of community members. Hence the developed
scale was more reliable and valid.

41
1.8 Limitation
This research study is limited by the jurisdiction which is limited to Pune. Though
overall the case laws at National Commission have been studied, actual study of live
cases and the awareness survey of Doctors and Patients are restricted to Pune
District. Also, the case laws study is restricted to the time from the application of the
Consumer Protection Act to the Medical Field i.e. 1987 to present i.e. 2013.. Thus
the researcher has studied the trends in the said for the period of about 25 years, but
local study is restricted to the Pune District.

Since the concept of Medical Negligence is a complicated issue, is more than a

matter between two parties- it is also a political issue.90 A subdivision of common law
that has engaged the attention of civil courts, in particular consumer forums, for last
few decades is „negligence‟, especially that of medical professionals. Litigation
arising from death or serious physical injury that a patient suffers as a result of
negligence in their treatment by medical professional has overburdened courts. It
has spread through India like an epidemic, without showing any signs of passing.91

The next chapter elaborates the concept of Medical Negligence as a whole,

extracted and analyzed from various branches of law in India and across the world.

90
Mason J.K. ,Laurie GT 2006, LIABILITY FOR MEDICAL INJURY, Law and Medical Ethics, p.296
91
Tapas Kumar Koley, 2010 MEDICAL NEGLIGENCE AND THE LAW IN INDIA, Medical Negligence
and Civil Laws, p 21
42