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Medical Negligence, Patients’
Safety and the Law
By Professor R.K. Nayak*
Introduction
An eminent English radiologist Robert Hutchison prayed:
“From… too much zeal for the new, and
contempt for the old; from putting knowledge before wisdom; science before
art: cleverness before commonsense; from treating patients as cases and for
making cure of disease more grievous than the endurance thereof: good Lord
deliver us1”
Ever since the formation of human history, the inherent sickness in one form
or the other and mortality of human beings have made the diagnosis and
treatment of diseases pertaining to humans a high-risk profession. The ancient risk relating to physical
retribution to the physician has been replaced by the modern risk of economic
compensation for the harm occurred.
Patients’ rights have been protected in various ways including
creation of the institution of “Patient Ombudsman” in seven European
Countries as an administrative system.2
It is also being suggested that in order to prevent physicians’ wrongs
in the absence of enforceable international regulations, an International
Medical Tribunal be constituted with authority to judge and punish health
care professionals in cases of violations of international human rights, and
of norms of medical conduct3. It is being argued that the independent body
such as the International Medical Tribunal should be established with the
sanction and authority of the United Nations, and it could be based on the
model of the International Criminal Court (ICC)4.
The Problem of Blameworthiness in Medical Profession
From 20th Century onwards, it has been witnessed awareness among people
regarding the fundamental rights guaranteed by the constitutions in other
countries and by the Constitution of India has increased. This has brought the medical profession
under sustained scrutiny of both the public and by the courts. Health care
professionals have faced legal actions instituted by the patients not only in
India but in other countries as well.
In the course of practice of medicine, healthcare professionals, just like
other people in different areas, have to face errors despite prudence and
care, such as wrong diagnosis and treatment, or by otherwise doing something,
which is termed as “wrong” or “harmful” – to their patients. Any kind of wrong action or misjudgement may result in the death of a patient. This
fallibility, inherent in the medical profession like in any other human
action(s), is directly related with legal action. In fact, in the medical
field, consequences are high and serious. Health care professionals will have
to learn to bear with not only their technical know-how, but also with their
moral fallibility in performance of their duty. It is said:
A good person is not described by a tabulation of single actions and choices
bereft of context but rather as the Greeks saw it, by their “self-making” or
the ability to learn from situations and, in consequences to change
themselves for the better.5
Patients should invariably be informed about the mistakes in diagnosis or
management – that is part of truth-telling and an issue that is hard to argue
against.6 To hide such mistakes from
patients or family is a violation of truth-telling in every sphere of life.7
Autonomy of Medical Professionals
Autonomy implies the ability to govern oneself in the best possible way. In Kantian theory it is the power to set
one’s own rules to conduct its duties.8 But there is a difference between
autonomy (or freedom) of the will and autonomy (or freedom) of action.9 In the
medical world, it is essential to know this difference. However, if the
patient is suffering due to the influence of dementia, hypoxia, hysteria,
drugs, alcohol and other such factors, he/she may be forced to lose his/her
freedom of thinking or decision-making due to lack of the capacity to grasp
the circumstance. Besides, if a patient is ill, is hospitalized and is in a
weakened state of health, but it is quite rational to often lose the capacity
to act prudently. “Such patients,
however, may have some capacity to function, but may not be able to translate
their clear will into action”. This
loss of power and consequently becoming, as it were, a prisoner of the
medical system is something especially feared by the patient.10
Actually, full autonomy of the will or action is a
Plato’s ideal which can never be fully achieved, nor is it achievable under
the human conditions. Biological
(including genetics) factors put serious challenges to the abilities of
medical professionals. The
environmental, cultural, upbringing factors and social conditions to a great
extent limit their capacity and willingness to perform their duties.11 Kant
who is considered an authority on the concept of autonomy, analysed this very well and said that only the “divine
being” is truly autonomous.12 The
limits of autonomy are set by forces that are, in a sense, external to the
will and beyond the control of man (and these may vary from time to time and
from situation to situation).13 There
are basic criteria which must be applied in determining the justification for
an action, and they are:
1. It
must be sufficiently informed;
2. It
must be based on adequate and broad-based deliberations;
3. It
must be not be based on internal or external coercion, and
4. It
must be in consonance or harmonious with an enduring world view.14
The information supplied to a patient must be easy for him/her to
understand. Technical details are not
normally grasped by patient and may be out of the range of his experience.
These, therefore, will not be termed as “informing”. It is aptly said:
Further, health care professionals
should make sure that such information is truly comprehended. Comprehension means more than merely the
ability to parrot facts. True
understanding, in addition to an essential cognitive part, includes
understanding on an emotional as well as, where possible, an experimental
plane. It must include some
understanding by the health care professional of what the diagnosis or
condition means to patients: not just what it is scientifically, but what it
connotes to and for patients: how it will be seen to impact on their daily
lives and what it means emotionally for them, given their personal
worldviews.15
Truth-telling
Truth-telling to a patient is an integral part and parcel of autonomy. A medical professional who employs all the
cardinal tenets of autonomy in the performance of his duties must tell the
absolute and unvarnished truth to his patient(s). Truth-telling, like other principles, works
as guidelines to moral behaviour and not as an
absolute entity. It cannot be followed
without rationality. If it is, then it becomes an end in itself instead of a
means to a moral end.16
Cassel observed that sick persons lose their
ability to think and decide about their problems. They are not merely normal
persons with the ‘knapsack of illness” strapped to their back.17 Often they may lose their adulthood
and revert to a more childish form of existence: in a sense… they exhibit autonomy-surrendered
behaviour.”18
The practice of medicine and the role of health care professionals are seen
as a money-making industry and patients are seen or treated as consumers of
health services. The notion of the health care industry or health-providing
mechanism has emerged due to “physicians as entrepreneurs or as workers in an
entrepreneurial enterprise were enmeshed in mutual competition”.19 This view
has also undergone changes; patients and physicians interact and their
interaction has assumed some good things. Pelligrino
and Thomasma20 have advocated that physicians should view closely:
 The patient’s ultimate good or “good of the
last resort”;
The good of the patient as a human being;
The patient’s particular good; and
The bio-medical good.
The patient’s ultimate good connotes the highest good that the patient
expects. The “good of the last resort” may be based on religious belief or
vision, “a secularly enunciated belief”.21
With regard to the good of the patient as a human being, it involves choices
and respect for his ability and competence.
The patient must be supplied with complete relevant information and
complete different opinions by the physician.
Any distasteful opinion must also be reverted to the patient. It is for the patient to choose or go with
a particular opinion keeping in view a particular good. A patient may like to take a greater or
lesser risk (e.g. in the case of a woman in the event that breast cancer is
diagnosed) and decide accordingly. In
such a case, a serious conflict may emerge between the patient and the
physician. And patient in such a situation would like to refer her case to
another health care professional(s). Compassionate negotiation can be the
solution to the problem in such cases.
The bio-medical good is considered to be good for the physician-patient
interaction and relationship as well.
Eventually, patients seek the help of physicians in their own interest
and inter alia for the good in mind. In case, if only higher good prevails, the
question arises whether the bio-medical good be sacrificed, neglected or kept
aside.22 In this regard it is said:
It is often here that negotiation is at
its most fruitful. Within the context of the patient-physician relationship,
patients cannot be forced to pursue the bio-medical good if they believe it
violates a higher value; on the other hand, it is here that patients cannot
simply be abandoned to their autonomy.23
It is believed that health care professionals should treat patients as their
friends, and not as consumers of services.
“The relationship between physicians and their patients emphasizes the
peculiar mixture of detachment and involvement.24 Many times the physicians have to carry out
professional duties, which are distasteful, disagreeable, painful, dangerous
and not praiseworthy to their patients.25
Rationality should govern emotion and to modify what Rousseau has
said, “the primitive sense of pity, or compassion.”26 If any professional
duty is performed rationally, based on medical ethics and in the interest of
patients to provide them relief, it will outdo any unreasonable criticism to
protect the human rights of those under treatment. India’s Ayurveda
system of medicine provides ample evidence about social medicine, medical
ethics and the role of the doctor in serving the people in general, and in
the larger interest of social good.27
Law on Medical Negligence
Negligence in the medical world has assumed great importance in relation to
the medical malpractices suits in various countries in Asia, Europe, USA and
more so in India. In the area of
patient-doctor relationship two important models dominate viz. one is based
on paternalism and other is founded on the doctrine of informed consent. According to Dworkin’s
standard definition of paternalism means “interference with a person’s
liberty of action justified by reasons referring exclusively to the welfare,
good, happiness, needs, interests or values of person coerced”28 Such definition may serve the needs of
patients but it does not serve the whole concept of welfare of the patients.
Feinberg advocates a division in the definition of paternalism, one that
preaches how to prevent harm and the other how to ensure the patient’s
good.29 Feinberg divided paternalism into “weak” and “strong”.
In Britain, the paternalistic model of the physician-patient relationship has
both been a dominant feature in the medical profession since its inception.30
This has been well emphasized in the modern English law through the famous Bolam principle,31 which states that
a doctor is not liable in negligence when he acted “in accordance with a
practice accepted as proper by a responsible body of medical men, skilled in
the particular art”. In the United States, the doctor-patient relationship is
based on the doctrine of informed consent.32 As per the doctrine of informed
consent, a patient must be supplied with all the necessary information about
the nature of treatment, risks involved and the feasible alternatives, so as
to enable him/her to make a rational and intelligent choice whether to
proceed with treatment or surgery or not.
In case informed consent of the patient concerned is not obtained,
then the physician would face tortuous liability. In Roe v. Minister of
Health,33 Lord Denning aptly said:
It is so easy to be wise after the
event and to condemn as negligence that which was only a misadventure. We ought always to be on our guard against
it, especially in cases against the hospital and the doctor. Medical science
has conferred great benefits on mankind, but these benefits are attended by
considerable risks. We cannot take the
benefits without taking risks. Every
advance in technology is attended by the risks. Doctors, like the rest of us, have to learn
by experience, and experience often teaches in a hard way. Something goes wrong and shows up a
weakness and then it is put right.34
Situation in India
Actually, the Constitution of India does not provide any special rights to
the patient. In fact the patient’s rights are basically indirect rights,
which arise or flow from the obligations of a physician or health care
provider under the Indian Medical Council (Professional Conduct, Etiquette
and Ethics) Regulations, 2002.
However, the basic rights of a patient, such as the right to know
about his condition, or the right to participate in treatment decision-making
do not exist in reality in medical practice.
If at all they exist, they exist only on paper or in philosophical
talks and discourses.
Besides, people have an expectation that if anything wrong occurs or is done
by medical professionals, then justice should invariably be done. It is
reasonable for a patient to expect medical doctors to take into consideration
all relevant factors involved in the treatment. At the same time, it is
reasonable for the medical professional to provide all reliable technical or
non-technical information about the treatment/ surgery in one go to the
patient. However, decision-making still remains in the hands of health care
professionals.
The basic principle is that medical doctors and associated medical profes-sionals are responsible and liable for wrongs and
failures in the performance of their medical duties towards patients. In India, generally Section 304-A of the Indian
Penal Code (IPC), 1860 is the relevant provision under which a complaint
against a medical practitioner for alleged criminal medical negligence is
registered. Section 304-A provides that whoever commits culpable homicide not
amounting to murder shall be punished for life or imprisonment for a term up
to 10 years and fine as well. Section
337 of the IPC deals with hurt caused by an act endangering life or personal
safety of others. Section 338 of the
IPC relates to grievous heart by an act endangering life and personal liberty
of others. However, the simple lack of care attracts only civil
liability. Therefore, only civil
negligence may not be enough to hold a medical professional criminally
liable.
In India, health care professionals or medical doctors must have reasonable
skills, knowledge, and proper medical education and competence to carry on
the practice of medicine. If they fail
in the criteria as narrated then they will be liable for incompetence in one
way or the other and may face:
1. Liability in respect of diagnosis;
2. Liability in relation to doctor’s duty to warn
the patient about the risks involved, and
3. Liability in relation to the treatment to be
carried out.35
The courts in India have generally followed the decisions and practices of the English
law. The cases of negligence in India are directly related to existing
facilities, infrastructure and level of acumen of medical professionals. In
many cases doctors have been held liable for negligent acts, such as removal
of a wrong eye or a kidney, based on precuniary
interest or where minimum facilities were available. In this regard, an
important example is of eye camps or health camps where operations are
performed without proper facilities. In A.S. Mittal
v. State of U.P.,36 the Supreme Court of India held that if a survivor fails to conduct
tests before the mass use of saline on patients, he is liable for negligence.
In the Lions Club eye camp conducted at Khurja, in
the State of U P 108 patients were operated out of which 84 patients’ eyes
were damaged due to post-operation infection of the intra-ocular cavity of
the operated eyes. This was due to a common contaminating source. The Supreme
Court held the doctors liable for negligence and directed that, in addition
to the sum of Rs 5 000/- already paid as interim
relief, the state government shall pay a sum of Rs
12 500/- to each victim. The question of standard care was highlighted by the
Supreme Court in Dr Laxman Balkrishna
Joshi v. Dr Trambak Bapu
Godbole.37 In this case, Anand, the son of the
respondent, died due to shock resulting from reduction of fracture attempted
by the doctor without taking the elementary caution of giving anaesthesia to the patient. The Bombay High Court, and
later the Supreme Court of India, held that the doctor was negligent in the
performance of his medical duty. The Supreme Court held that the duty of a
doctor will include (a) a duty of care in deciding whether to undertake a
case and (b) a duty of care in deciding what treatment to give or a duty of
care in administration of that treatment. Any breach of these duties gives a
rise of action for negligent acts towards the patient. The Court also
observed that the doctor has the discretion in choosing the treatment, which
he proposes to give to the patient in one way or the other. The discretion of
the doctor is relatively wider in cases of emergency. In this way the Supreme
Court of India has affirmed the English law on the subject, viz. that the
breach of duty of care is the basis for liability for negligence and secondly
it lays down the standard of care i.e. the doctor must bring to his task a
reasonable degree of skill and knowledge and must exercise a reasonable
degree of care.
The Supreme Court of India in its landmark judgment in Indian Medical
Association v. V.P. Shanta38 laid down the law relating to professional
negligence under Consumer Protection Act, 1986 and enunciated certain
principles that medical practitioners, government hospitals, and private
hospitals and nursing homes are also covered under the consumer law in the
following categories:39
1. Where services are rendered free of charge to
everybody availing of the said service;
2. Where charges are required to be paid by
persons availing of services, but certain categories of persons who cannot
afford to pay are rendered service free of charge, and
3. Where charges are required to be paid by
persons availing of services, but certain categories of persons who cannot
afford to pay are rendered service free of charge.
The services provided in the first category by doctors and hospitals would
not be covered by the services under section 2(1)(0)
of the Consumer Protection Act, 1986.40 But the services rendered by the
second and third categories of doctors and hospitals would be covered within
the ambit of the service defined in the above provision of the Act, 1986.
In a recent verdict in the Dr Suresh Gupta v. Government. of
NCT of Delhi,41 the Supreme Court of India held that an error of judgment on the part
of the doctor does not make him criminally liable. This came as a relief to
the medical community in India. In the instant case, the appellant a
doctor (plastic surgeon) was in the dock as an accused on the charge under
Section 304 of the Indian Penal Code (IPC)42 for
causing death of his patient, who was operated by him for removing his nasal
deformity. The patient died during the course of the surgical operation.
The Supreme Court very clearly and categorically made the following obser-vations on the law of negligence:
The legal position is almost firmly established that where a patient dies due
to the negligent medical treatment by the doctor, the doctor can be made
liable in civil law for paying compensation and damages in tort and at the
same time, if the degree of negligence is so gross and his act was reckless
as to endanger the life of the patient, he would also be made criminally
liable for offence under Section 304-A of the Indian Penal Code (IPC).43
The apex court said that for fixing the criminal liability of the doctor or
the surgeon, the standard of negligence should first be provided whether it
is “gross negligence of recklessness”. The mere lack of necessary care,
attention and skill will not constitute “gross negligence or recklessness”.44
The Supreme Court relied on the House of Lords, decision in R. V. Adomako45
in which the principle is well elucidated:
The laws of negligence apply to
ascertain whether or not the defendant has been in breach of a duty of care
towards the victim who has died. If such breach of duty is established, the
next question is whether that breach of duty caused the death of the victim.
If so, the jury must go on to consider whether that breach of duty should be
characterized as gross negligence and, therefore, a crime. This will depend
on the seriousness of the breach of duty committed by the defendant in all the
circumstances in which the defendant was placed when it occurred.46
The Supreme Court of India in its classic judgment reasoned that in every
mishap or death during medical treatment, the medical man cannot be made
criminally liable for punishment. In the absence of adequate medical opinion,
putting guilt on the medical man would be doing great harm or disservice to
the medical community at large. “Every mishap or misfortune in the hospital
or clinic of a doctor is not a gross act of negligence to try him for an
offence of culpable negligence.47” Therefore, the Supreme Court relied on the
English autho-rities, Alan Merry and Alexander
McCall Smith, on their views that blame – a powerful weapon – should be used
in an appropriate manner with defensible criteria as it has an indispensable
role in human affairs. Some of the misfortunes or wrong are merely accidents
for which no one should be held responsible. Some instances are of culpable
conduct, which constitute the basis for compensation and, at times, for punishment.
To be able to distinguish, different categories of wrongs or careless-ness,
calls for “careful, morally sensitive and scientifically informed
analysis”.48
The Supreme Court quashed the criminal proceedings against the doctor and set
aside the orders of the magistrate and of the High Court of Delhi and held
categorically in the instant case held:
“We find that no recklessness or gross negligence has been made out against
the doctor to compel him to face the trial for the offence under section 304A
of IPC.49”
The judgment of the Supreme Court has been referred to a larger Bench by the
apex court itself for reconsideration. Neverthe-less,50
the verdict of the Supreme Court has opened a new vista for medical ethics in
India. Laws in India do not prescribe any sets of rights for
the welfare of patients. Health care professionals are also not bound to
provide information on the course of treatment to the patient or his/her
nearest relations or family members. Patients feel helpless in such situations
and depend on the decision and acumen of physicians/ surgeons about the
proposed treatment. The Constitution of India does not provide any special
rights to a patient. However, the rights are basically indirect rights which
arise from the performance of duties of health care professionals. However,
the Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulations, 2002 do provide some safety and rights to patients. The basic
rights such as right to know about his condition, right to participate in
treatment decisions, right to have discussion with the doctor(s) are alien to
patients in the world of medical treatment.
Conclusion
The development of law on negligence pertaining to professionals’ liability
in countries of the South-East Asia Region is not known. However, the same
needs to be developed. Excepting India, no information on what courts are doing, and what legislations exist in the Region is
available on the Internet or in books. Therefore, the subject of law on
negligence and patients’ safety is very much needed, and it must be taken up
in the right earnest by WHO. Any study of law on the
subject in the SEA Region must also tackle the problem of speedy award of
substantial compensation in cases of negligence, and awareness of one’s
right. This will go a long way in ameliorating the conditions of patients who
have to suffer due to the negligence or reckless acts of health care
professionals, and sometimes due to quacks performing the functions of a
qualified medical professional. To conclude, it will be apt to quote:
The practice of medicine is a social task in which the patient and the healer
must respect each other’s personal morality and moral agency. The vastly
greater power (real or perceived) of the health care provider and specifically
of the physician puts the burden of this fiduciary relationship largely (but
not solely) on the shoulders of health care providers. While health care
providers cannot – and act ethically – impose their own personal morality on
the patient, neither can the patient ask physicians
to violate their own personal morality...51. They carry a heavy
responsibility in trying to resist the dictates deemed harmful to their
patients.
References
1. Sir Robert Hutchinson quoted in A.Ghosh, “Whose Life Is It, Any Way?”
The Times of India (New Delhi)
p.11 (Sept. 11, 2004)
2. L. Fallberg et al,,
Patient Ombudsman in Seven European Countries, 1D European J of Health Law
343 (2003). This system is in
operation in Austria,
Finland, Greece,
Hungary, Israel,
Norway and
the UK. For details see L. Fallberg,
S. Mackenney (Eds.)
Protecting Patients Rights: A comparative Study of the Ombudsman in
Healthcare (Oxford: Radcliffe Medical Press, 2003).
3. G.J. Annas &
M.A. Gordin, “Medical Ethics and Human Rights:Legacies of Nuremberg”,
3, Hofstra L. & Pol’y
Symp. At 118 (1999)
4. Id.
at 119.
5. E. Pincoffs, “Quandry Ethics”, 80 Mind 552-571
(1971).
6. .E.H. Loewy et al,
Textbook of Health care Ethics, 71 (2004).
7. Ibid.
8. Id.
at 75.
9. Ibid.
10.
Ibid.
11.
Id.
at 75-76.
12.
Id.
at 76
13.
Ibid.
14.
M.A. Lee, L. Ganzini,
Depression in the Elderly: Effect on Patient Attitudes Towards
Life-sustaining Therapy, 40 J. Am. Geriatr Soc.
983-88 (1992).
15.
E.H. Loewy et al.,
supra note 4 at 83.
16.
Id.
at 85.
17.
Id.
at 101.
18.
Ibid.
19.
Id at 104.
20.
See generally, E.D. Pellegrino et al., “For
the Patient’s Good: The Restoration of Beneficence in Healthcare”, (Oxford Uni.Press, New York, N.Y., 1988).
21.
See supra note 4 at 106.
22.
Ibid.
23.
Id.
at 106-107.
24.
See generally E.H. Loewy,
“Friendship and Medicine”, 3(1) Cambr Q.Health Care Ethics 52-59 (1994).
25.
Ibid.
26.
Supra note 4 at 107.
27.
R.K. Nayak,
“Imperative of Global Health Law for the 21st Century” in Global Health Law,
33 at 40 (WHO and I.L.I. joint publication, 1997).
28.
See generally G., “Dworkin,
“Paternalism”, 56 Monist. 64-84 (1972).
29.
J. Feinberg, “Legal Paternalism”, 1 Cen.J. Phil. 105-124 (1971).
30.
See generally Chapman, “Physicians’ Law and
Ethics” (1984).
31.
Bolam v. Friem Hospital
Management Committee (1957) 2 All ER 118 at 121.
32.
Schloendroff v.
Society of New York Hospital,
211 N.Y. 125 N.E. 92, 93 (1914) (as per Justice Cardozo).
33.
(1954) 2 All ER 131; (1954) 2 QB 66.
34.
Id.
at 137.
35.
This is the situation in the laws of U.K.
36.
(1989) 3 SCc
223.
37.
AIR 1969 S.C. 128; see also Ram Bihari Lal v. J.N. Shrivastava,
AIR 1985 M.P. 150 and T.T. Thomas v. Elisa, AIR 1987 Ker.52.
38.
AIR 1996 S.C. 550.
39.
Id.
at 563-64.
40.
Section 2(1)(0)
Provides: “Services” means service of any description is made available to
potential users and includes the provision of facilities in connection with
banking, financing insurance, transport, processing, supply electrical or
other energy, board or lodging or both, (housing construction) entertainment,
amusement or 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.
41.
AIR 2004 SC 4091.
42.
Section 304, IPC provides “Whoever commits
culpable homicide not amounting to murder, shall be punished with
imprisonment for life, or imprisonment of either description for a term which
may extend to ten years and shall also be liable to fine, if the act by which
the death is caused is done with the intentin of
causing death…
43.
Supra note 41 4094.
44.
Id.
at 4095.
45.
(1994) 3 All ER 79.
46.
Id.
at 86.
47.
Supra note 41 at 4095.
48.
A. Merry and A.McCall
Smith, “Errors, Medicines and the Law, quoted in supra note 38 at 4096.
49.
Supra note 41 at 4096.
50.
L.C., S.C. Judgment on Doctors’ Criminal
Liability for Larger bench, The Times of India (New
Delhi) p.1 (10
October, 2004).
51.
Supra note 6 at 137.
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