SEMINAR PAPER 4- LAW AND MEDICINE

TITLE: High Stakes, Higher Thresholds: Proving Medical Negligence

Submitted by:
AnushaShivaswamy- 15040142026
Nikita Ganesh – 15040142014
BBA LLB- A (2015-2020)

Submitted to: Prof.Jithin

Alliance School of Law

Alliance University, Bangalore
23rd April, 2020

1
 ABSTRACT
With growing public awareness of medical negligence, hospital managements are
increasingly facing complaints. As a result, a number of legal decisions have been made on
what constitutes negligence and what is required to prove the same. A breach of duty of care
gives the patient the right to initiate action against negligence. However, if a plaintiff alleges
that there is breach of duty of care, it becomes difficult to determine the exact damage and the
nexus between the cause and effect. The courts have a joint opinion that the onus to prove
negligence is vested on the plaintiff. This may become difficult when medical professionals
or hospitals may conceal such evidence to protect their interest and goodwill. The scope of
this paper will be to study analyze the principle of medical negligence with respect to proving
acts of medical negligence and the importance transparency of medical records of patients in
order to prove negligence. The paper highlights the principle of medical negligence and
suggests ways to improve transparency of patient data thereby making hospitals accountable
for their actions.

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 TABLE OF CONTENTS

Contents Page No.

Chapter 1: Introduction……………………………………………………………….…4-8
1.1 Research Background
1.2 Research Problem
1.3 Research Question
1.4 Hypothesis
1.5 Scope of the Study
1.6 Objective of the Study
1.7 Literature Review
1.8 Research Methodology
Chapter 2: Concept of Negligence…………………………………………………...…..9-11
2.1 Essentials to Prove Negligence
2.1.1 Duty of Care to the Plaintiff
2.1.2 Breach of Duty of Care
2.1.3 Consequential Damages
2.2 Civil and Criminal Negligence
Chapter 3: Medical Negligence………………………………………………...……….12-17
3.1 Duty of Care
3.2 Proving Medical Negligence
3.2.1 Res Ipsa Loquitur
3.2.2 Burden of Proof
Chapter 4: Medical Records and Issues in Proving Medical Negligence……………18-21
4.1 Necessity of Effective Record Keeping
4.1.1 Duration of Preservation of Medical Records
4.1.2 Ownership of Medical Records
4.2 Transparency of Patient Information/ Data
4.3 Legal Regime in India in Relation to Health Data
Chapter 5: Conclusion and Suggestions………………………………………………...…21
Bibliography……………………………………………………………………………..22-24

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 CHAPTER1: INTRODUCTION

1.1 RESEARCH BACKGROUND

After the Consumer Protection Act, 1986, came into effect, a number of patients have filed
cases against doctors. Public awareness of medical negligence in India is growing. Hospital
managements are increasingly facing complaints regarding the facilities, standards of
professional competence, and the appropriateness of their therapeutic and diagnostic
methods. Patients have filed legal cases against doctors, having established that the doctors
were negligent in their medical service, and have claimed and received compensation. As a
result, a number of legal decisions have been made on what constitutes negligence and what
is required to prove medical negligence.

In the legal sense, negligence is the breach of a legal duty to care. It means carelessness in a
matter in which the law mandates carefulness. A breach of this duty gives a patient the right
to initiate action against negligence. Persons who offer medical advice and treatment
implicitly state that they have the skill and knowledge to do so, that they have the skill to
decide whether to take a case, to decide the treatment, and to administer that treatment. This
is known as an “implied undertaking” on the part of a medical professional.

It is very difficult to define negligence categorically since there is no consensus upon the
same. There are three consequences of negligence, namely,

1. A duty of the party complained of to exercise due care towards the party complaining
the former’s conduct within the scope of his duty;

2. Breach of the said duty;

3. Consequential damages that follows
Indian criminal law has placed medical profession on a different footing. Section 304A of the
Indian Penal Code, states that ‘whoever causes the death of a person by rash or negligent act
not amounting to culpable homicide shall be imprisoned for a term of two years or with a or
both’.

However, proving medical negligence is different from other cases of negligence as there are
many elements involved. This paper seeks to address the complexity of medical negligence
pleas.

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1.2 RESEARCH PROBLEM

The legal principle of negligence though wide in scope cannot be applied directly to medical
cases. This is because medical professionals are persons professing some special skill and the
tasks performed by them require the highest care and caution, above that of an ordinary
prudent person. This creates a conundrum of whether there is a need to prove such negligence
or whether the principle of res ipsa loquitur applies. If the plaintiff alleges that there was
breach of duty of care, it becomes difficult to determine the exact damage and the nexus
between cause and effect of the injury because medical practitioners/hospitals may conceal
such evidence required by patients to protect their interest and goodwill. Thus, it becomes
difficult to establish liability on the part of the medical practitioner/hospital. These issues are
not adequately addressed in the Indian legal regime.

1.3 RESEARCH QUESTIONS

1. Whether the principle of res ipsa loquitur holds good for all cases medical negligence?

2. Whether the current legal regime in India effectively addresses the need for transparency
of patient information that is necessary to prove medical negligence?

1.4 HYPOTHESIS

The principle of res ipsa loquitur cannot be applied to all cases of medical negligence and
therefore there is a requirement for transparency of patient information in order to prove
negligence.

1.5 SCOPE OF THE STUDY

The study will be limited to the principle negligence in general and then with medical
negligence under the Indian legal regime and not medical malpractice.

1.6 OBJECTIVE OF THE STUDY

1. To critically analyze the concept of medical negligence in the Indian legal regime

2. To evaluate the circumstances under which the doctrine of res ipsa loquitur can be applied

3. To study the necessity for transparency of patient information in order to prove negligence

4. To evaluate the current laws in India in relation to transparency of patient information

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1.7 LITERATURE REVIEW

Henry T Terry, 'Negligence' (1915) 29 Harvard Law Review 40

This paper gave a general idea of negligence and defining it in terms of breach of duty. The

paper considers negligence as conduct which involves an unreasonably great risk of causing

damage. The paper helped with a deeper understanding of negligence and how conduct must

pose a reasonably foreseeable risk to be considered “negligent”

SvJoga Rao, 'Medical negligence liability under the consumer protection act: A review

of judicial perspective' (2009) 25 (3) Indian Journal of Urology 361

The paper helped in understanding what medical negligence is and the applicability of

consumer protection and criminal law. The paper also contained relevant case laws used to

explain the duty, degree of care and proof required to prove medical negligence.

OnyekachiDuru, ‘The Applicability of the Doctrine of Res Ipsa Loquitur Negligent

Actions: A Critical Appraisal’ [2012] Legal Emperors

This paper analyses the applicability of the principle of Res Ipsa Loquitur in negligent

actions. It highlights the essentials and effects of the application of the principle in case

involving negligent actions. In the final analysis, the paper submits that the doctrine has

assisted the courts in ensuring that persons who suffer harm or damage as a result of the

careless conduct of others are protected are duly compensated. It helped to understand the

applicability of the principle.

Sreya B, ‘Consumer Rights and Medical Negligence’ [2013] NUJS Law Review

This paper states that every possible injury to the patient might not be caused by the doctor’s

incapability or negligence. All cases should be dealt on a singular basis to determine whether

such facts exist to make a doctor liable for his negligence. Pointing a finger to a professional

6
is easy, but proving his omission is hard. Therefore, res ipsa loquitur cannot be used to prove

medical negligence.
Joseph Thomas, ‘Medical Records and Issues in Negligence’ (2009) 25 Indian Journal of
Urology 384

This paper highlights the importance of proper documentation of patient information.

Medical documentation is an important part of management of a patient. The first reason for
the same is for the evaluation of patient profile. The second and equally important reason is
for the requirement of such information in the case of alleged medical negligence. The paper
highlights the legal practice, where the system relies on documentary evidence in a situation
where medical negligence is alleged by a patient. The paper stipulates that this can be major
limitation as poor documentation means poor defense and no documentation means no
defense. The paper states that even though medical record keeping is an important aspect of
hospital management, the same is yet to develop into a proper process.

Ilayanambi B, ‘Challenges Before Data Privacy Laws in India: With Special Reference
to Protection of Patients Information’ (2019) 1 Law Audience Journal 24

This paper highlights the importance to know a patient’s data and patient’s treatment
confidentiality. The paper provides an overview of various data protection regimes of various
countries such as EU, UK and US and compares them to the current position in India. The
paper also critically analyses DISHA 2018 Bill which is a primarily Health Care Data Privacy
Act. The paper highlights the necessity to define ‘personal information’ separately under
DISHA Bill with regards to the usage of health and medical information.

Nimisha Srinivas and Arpita Biswas,‘Protecting Patient Information in India” Data

Privacy Law and Its Challenges’ (2018) 11 NUJS Law Review 409

The paper emulates how Electronic storage of medical records has exposed individuals to the
risk of identification at various stages of data collection and data processing. It states that two
options are available to data miners: to either anonymize information that poses a risk of
identification or make such information available to physicians alone. The second option is
no longer feasible in a world where the physician-patient relationship is complicated by the
presence of other stakeholders, such as insurers and pharmaceutical manufacturers. Finding
the proverbial middle path is the only solution to the ethical dilemma posed by the
appropriation of patient information for marketing purposes. This paper presents an overview

7
of various data protection regimes, followed by an analysis of the Indian position on data
privacy.

Abhishek R Bhardwaj and Kuljit Singh, ‘Medical Negligence in India: A Study with
Special Reference to Liability in Tort’ (2018) 3 International Journal of Academic
Research and Development 1415

The paper revaluates the doctor- patient relationship and the concept of medical negligence in
India. It states that Medical negligence, now days have become one of the serious issues in
India. Our experience tells us that medical profession, one of the noblest professions, is not
immune to negligence which at times results in death of patient or complete / partial
impairment of limbs, or culminates into another misery. There are instances wherein most
incompetent or ill/under educated doctors, on their volition, have made prey the innocent
patients. The magnitude of negligence or deliberate conduct of the medical professionals has
many times led to litigation.

1.8 RESEARCH METHODOLOGY

The research is doctrinal in nature. The sources are primary and secondary in nature. The
primary sources include relevant acts like Consumer Protection Act, 2019, Indian Penal
Code, 1860 and relevant case laws.

The secondary sources include research papers, reports by Medical Council of India, and
newspaper articles.

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 CHAPTER 2: THE CONCEPT OF NEGLIGENCE
Accidents happen due to various reasons but in law, one is only concerned with the cause and
effects of the accidents in order to ascertain the party responsible for the accident. This is
dealt with under a concept called negligence. Negligence in its simplest sense means
carelessness and in the legal sense, it means failure to exercise a standard of care, which the
doer ought to have taken as a reasonable prudent man.

There is no specific definition of negligence. According to Winfield and Jolowicz, negligence

is“the breach of a legal duty to take care which results in damage, undesired by the defendant
to the plaintiff” 1

In  Blyth v Birmingham Water Works Co,2 negligence was defined as “the omission to do
something which a reasonable man would do or doing something which a prudent or
reasonable man would not do.”

In Jacob Mathew v State of Punjab and anr,3 the 3 judge bench cited
RatanlalDhirajlal,4“Negligence is the breach of a duty caused by 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.”

This definition involves three constituents of negligence:

i) A legal duty to exercise due care on the part of the party complained of towards the party
complaining the former’s conduct within the scope of the duty;

ii) Breach of the said duty; and

iii) Consequential damage

2.1 ESSENTIALS TO PROVE NEGLIGENCE

2.1.1 Duty of Care to the Plaintiff

Negligence is conduct which involves an unreasonably great risk of causing damage and due
care is conduct which does not involve such a risk.5This duty of care means a legal duty and

1
Winfield and Jolowicz, Tort (18th edn, Sweet and Maxwell 2010) 45
2
(1856) LR 11 Exch. 781
3
AIR 2005 SC 3180
4
Ibid citing Ratanlal and Dhirajlal, Law of Torts (24thedn, Lexis Nexis 2002) 441-442
5
Henry T Terry, 'Negligence' (1915) 29 Harvard Law Review 40

9
not a mere moral one. This duty arises when law recognizes a particular relationship between
the plaintiff and the defendant requiring the defendant to act in a certain manner towards the
plaintiff. It has to be established that the defendant owed a certain duty of care towards the
plaintiff which was propounded in the landmark case Donoghue v Stevenson.6 Lord Atkin
observed:

“You must take reasonable care to avoid acts or omissions which you can reasonably
foresee would be likely to injure your neighbour.”

He further defined ‘neighbours’ as

“the persons who are so closely and directly affected by my act that I ought
reasonably to have them in contemplation as being so affected when I am directing
my mind to the acts or omissions which are called in question.”

2.1.2 Breach of Duty of Care

It must also be established that there was a breach of said duty of care. There is a breach of
duty when due care and caution is not exercised and the standard of care required is that of a
reasonable or of an ordinary prudent man. The law does not require the greatest possible care
but the care required is that of a reasonable man. The following have to be taken into
consideration while determining the standard of care:7

i) Importance of the object to be attained

ii) Magnitude of risk

iii) Amount of consideration for the services offered

2.1.3 Consequential Damage

It is also necessary that the defendant’s breach of duty must cause damage to the plaintiff,
which was a consequence of the defendant’s negligence. The damages may be to the person,
which is either physical or mental, to property, or may be financial in nature. The onus is on
the plaintiff to prove all items of damages so the court may assess the exact amount of
damages.

6
(1932) A.C.562
7
RK Bangia, Law of Torts (23rd edn, Allahabad Law Agency 2013) 236

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2.2 CIVIL AND CRIMINAL NEGLIGENCE

Although the paper is not concerned with the nature of negligence, it is still important to lay
down the thin line of difference between negligence as a tort and as a crime. In tort law, it is
only regarding the amount of damages but in criminal law, it is about the degree of
negligence.

To fasten liability in Criminal Law, the degree of negligence has to be higher than that of
negligence enough to fasten liability for damages in Civil Law.8

The plaintiff can file a complaint under the Consumer Protection Act, 1956 for “deficiency of
service” and criminal complaints can be filed against doctors alleging commission of
offences punishable under Section 304A or Sections 336/337/338 of the Indian Penal Code
alleging rashness or negligence on the part of the doctors resulting in loss of life or injury (of
varying degree) to the patient.

Under civil law, the remedy is to pay compensation for the damages sustained but under
criminal law, the doctor may also be jailed. It was further held in the Jacob Mathew case that
to prosecute a medical professional for negligence under criminal law it must be shown that
the accused did something or failed to do something which in the given facts and
circumstances no medical professional in his ordinary senses and prudence would have done
or failed to do.

8
Ibid 3

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 CHAPTER 3: MEDICAL NEGLIGENCE

Medical negligence cases are very peculiar because the damage caused is very apparent and it
is also apparent that any action or omission of the doctor, staff or the hospital caused the
damage. It therefore creates a conundrum as to whether res ipsa loquitur can be applied or
whether the negligence has to be proven.

In Jacob Mathew v State of Punjab,9 the Apex Court explained:

“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. Any reasonable man entering into a profession
which requires a particular level of learning to be called a professional of that branch,
impliedly assures the person dealing with him that the skill which he professes to
possess shall be exercised and exercised with reasonable degree of care and
caution…….The only assurance which such a professional can give or can be
understood to have given by implication is that he is possessed of the requisite skill in
that branch of profession which he is practising and while undertaking the
performance of the task entrusted to him he would be exercising his skill with
reasonable competence. This is all what the person approaching the professional can
expect.”

There is no shred of doubt that the medical profession is the most respected and humanitarian
profession. Therefore, it attracts a certain moral code of ethics which is inherent in the
doctor-patient relationship, at the heart of which lies the principle of trust. The above case
states that doctors profess a special skill, thereby, the standard of care that they have to take is
that which a reasonable person possessing that skill has.The standard to be applied for
judging, whether the person charged has been negligent or not, would be that of an ordinary
competent person exercising ordinary skill in that profession.10

A patient approaches a doctor because he is in need of care and any act or omission
furthering the need of care creates an apprehension in our minds that doctors cannot be

9
Ibid 3
10
Ibid

12
trusted. Keeping this in mind, it is safe to assume that medical negligence is no ordinary tort
and therefore cannot be dealt as such.

3.1 DUTY OF CARE

As discussed earlier, in order to prove negligence, it has to be proven that the defendant owed
a certain duty of care to the plaintiff. In the Jacob Mathews case, it was held that doctors
profess a special skill, thereby, the standard of care that they have to take is that which a
reasonable person possessing that skill has. This does not mean that a doctor has to assure
that every patient who comes to him seeking medical help needs to be cured. It merely means
that a doctor will exercise reasonable care and caution while dealing with a case. There is a
difference between standard of care and degree of care. The standard of care is a constant and
remains the same in all cases.11 The degree of care, however is variable and depends on the
circumstances. For example, the degree of care that is expected from a specialist is higher
than what is expected of a generalist. Courts do accept the need to impose a higher degree of
duty on a specialist.12

The degree of skill and care required by a medical practitioner as explained in Halsbury’s
Law of England13 is:

“The practitioner must bring to his task a reasonable degree of skill and knowledge,
and must exercise a reasonable degree of care. Neither the very highest nor a very low
degree of care and competence, judged in the light of the particular circumstances of
each case, is what the law requires, and a person is not liable in negligence because
someone else of greater skill and knowledge would have prescribed different
treatment or operated in a different way nor is he guilty of negligence if he has acted
in accordance with a practice accepted as proper by a responsible body of medical
men skilled in that particular art, even though a body of adverse opinion also existed
among medical men.”

InDr.LakshmanBalkrishna Joshi v Dr.TrimbakBapuGodbole,14 it was held that a doctor

owes the patient the following duties of care:

11
SvJoga Rao, 'Medical negligence liability under the consumer protection act: A review of judicial
perspective' (2009) 25 (3) Indian Journal of Urology
 <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2779962/> accessed 23 April 2020
12
Ibid
13
Cited in Ibid 3
14
AIR 1989 P and H 183

13
i) A duty of care in deciding whether to undertake this case;

ii) A duty of care in deciding what treatment to give; and

iii) A duty of care in the administrating that treatment properly

A breach of any of any of the abovementioned duties gives a right of action for negligence to
the patient. It was further held that a reasonable degree of care needed to be exercised.

3.2 PROVING MEDICAL NEGLIGENCE

3.2.1 Res Ipsa Loquitur

The maxim means ‘the thing speaks for itself” and is a presumption under negligence,
which basically shifts from the plaintiff to the defendant.In a negligence action if the plaintiff
cannot make out a breach of defendant's duty of care there will be no suit and it is the purpose
of the res ipsa loquitur doctrine, in appropriate cases, to supply this missing element by
inferring the breach from the nature of the injury. 15 It basically indicates that a breach of a
party's duty of care may be inferred from the events that occurred. In other words, the
negligence is so obvious that you can tell that someone had a negligent hand in what
happened.
Although medical negligence needs to be dealt with in a manner different from regular cases
of negligence, there is no blanket exclusion of the principle of res ipsa loquitur. It is well
settled that in cases of gross medical negligence, where there can be no other inference, the
principle of res ipsa loquitur can be applied.16It is applied when the negligence is of a higher
degree causing maximum damage.
In the Jacob Mathews case,17 it was held that res ipsa loquitur is only a rule of evidence and
operates in the domain of civil law especially in cases of torts and helps in determining the
onus of proof in actions relating to negligence. It cannot be pressed in service for determining
per se the liability for negligence within the domain of criminal law, However, even in civil
jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied
with extreme care and caution to the cases of professional negligence and in particular that of
the doctors. Simply because a patient has not favourably responded to a treatment given by a

15
David S Rubsamen, 'Res Ipsa Loquitur in California Medical Malpractice Law--Expansion of a Doctrine to
the Bursting Point' (1962) 14 Stanford Law Review 251
16
Spring Meadows Hospital v Harjot Ahluwalia AIR 1998 SC 1801
17
Ibid 3

14
physician or a surgery has failed, the doctor cannot be held liable per se by applying the
doctrine of res ipsa loquitur.
Some typical cases where res ipsa loquitur is applied include wrong operation on a wrong
patient or a wrong part of the body, leaving some foreign material in the body, performing an
abortion or any other operation or surgery which is prohibited in law, transfusion of improper
blood etc.
In AchutraoHaribhauKhodwa and Others v. State of Maharashtra and Others,18 the
deceased, the appellant's relative was admitted to a government hospital for a sterilization
operation. During the operation however, a mop was left inside the body of the deceased
leading to the pus formation and subsequent death. The appellant could not have proved the
negligence of the doctors and hence the doctrine of res ipsa loquitur was applied to hold the
defendants liable as the court felt that it was a negligent act of the defendants in leaving the
matter behind which caused the death and that this act was well within the control of the
defendants.
Thus, in medical negligence cases,resipsa loquitur will only apply if:19
i) The injured patient proves that the harm ordinarily would not have happened unless
someone was negligent;
ii) The harm occurred while the injured party was under the care and control of the health
care provider, and
iii) The injured patient did not contribute to the harm.
Thus, res ipsa loquitur is only applied when there is no other inference and it is clear that the
doctor’s negligence led to the damage caused. This is only used in severe cases, where there
is gross medical negligence and recklessness leading to death. The California Supreme Court
held that, “Another factor which some of the cases have considered in applying the doctrine
is that the defendant may have superior knowledge of what occurred and that the chief
evidence of the cause of the accident may be accessible to the defendant but inaccessible to
the plaintiff”20 and the same can be said to Indian cases as well.
3.2.2 Burden of Proof
The burden of proof is correspondingly greater on the person who alleges negligence against
a doctor.21The duty of care has already been discussed so we only need to discuss the breach
of duty of care. A professional may be held liable for negligence on one of two findings:
18
AIR 1996 SC 2377
19
Ibid 15
20
Ibid 15 citing Zentz v. Coca Cola Bottling Co., 39 Cal. 2d (1952)
21
Ibid 11

15
either he was not possessed of the requisite skill which he professed to have possessed, or, he
did not exercise, with reasonable competence in the given case, the skill which he did
possess.
Deviation from normal practice is not necessarily evidence of negligence. To establish
liability on that basis it must be shown (i) that there is a usual and normal practice; (ii) that
the defendant has not adopted it; and (iii) that the course in fact adopted is one no
professional man of ordinary skill would have taken had he been acting with ordinary care.22
Many judges in India have upheld the Bolam23 test for medical negligence pleas, which was
summarized in Eckersley v. Binnie:.24
“a professional man should command the corpus of knowledge which forms part of
the professional equipment of the ordinary member of his profession. He should not
lag behind other ordinary assiduous and intelligent members of his profession in
knowledge of new advances, discoveries and developments in his field. He should
have such an awareness as an ordinarily competent practitioner would have of the
deficiencies in his knowledge and the limitations on his skill. He should be alert to the
hazards and risks in any professional task he undertakes to the extent that other
ordinarily competent members of the profession would be alert. He must bring to any
professional task he undertakes no less expertise, skill and care than other ordinarily
competent members of his profession would bring, but need bring no more”
It was further held in Dr.Akhil Kumar Jain v. Lallan Prasad25that a doctor cannot be held
negligent simply because something went wrong or because someone else of better skill or
knowledge would have prescribed a different treatment or operated in a different way. He is
not guilty of negligence if he has acted in accordance with the practice accepted as proper by
a reasonable body of medical professionals. This was upheld in Dr.LakshmanBalkrishna
Joshi v Dr.TrimbakBapuGodbole26Therefore, res ipsa loquitur cannot be applied and it is for
the plaintiff to prove the negligence or deficiency in service by adducing expert evidence or
opinion and this fact is to be proved beyond all reasonable doubts. Mere allegation of
negligence will be of no help to the plaintiff.27
In Mam Chand vDr.  GS Mangat of Mangat Hospital,28 it was held that:
22
Ibid 3 citing the works of Charlesworth and Percy on negligence
23
Bolam vFriern Hospital Management Committee, [1957] 1 W.L.R. 582, 586
24
[1988] 18 Con.L.R. 1, 79
25
2004;(II) CPJ 504.
26
Ibid 14
27
Smt. Savitri Singh v Dr.Ranbir PD. Singh and others. 2004 (1) CPJ 25 (Bihar)
28
 2004;(I) CPJ 79 (NC)

16
 “Allegation of medical negligence is a serious issue and it is for the person who sets
up the case to prove negligence based on material on record or by way of evidence”

In Smt. Vimlesh Dixit vDr. R.K. Singhal,29it was held thata mere allegation will not make a
case of negligence unless it is proved by reliable evidence and is supported by expert
evidence.

Moreover, it was held in the Jacob Mathew case that res ipsa loquiturcannot be used in
criminal negligence and therefore, plaintiffs have to prove the case with essential evidence
and since judges are not medicine experts, they have to rely on the opinion of certain experts
while dealing with medical negligence. But there are very high chances of these experts
leaning towards the defendant doctors, which is why transparency is of utmost importance.
Moreover, the hospital will be vicariously liable and therefore, a need to preserve patient
information arises.

CHAPTER 4: MEDICAL RECORDS AND ISSUE IN PROVING

NEGLIGENCE

29
2004;(I) CPJ 123

17
This chapter will analyze the importance to properly document medical records. This is
because the legal system relies mainly on documentary evidence in a situation where medical
negligence is alleged by the patient. Furthermore, this chapter also aims to evaluate the
current data privacy regime in relation to health data and whether the same effectively
accounts for transparency of patient related information.

4.1 NECESSITY EFFECTIVE MEDICAL RECORD KEEPING

Medical records form an important part of the management of a patient. It is important for the
doctors and medical establishments to properly maintain the records of patients for two
important reasons. The first one is that it will help them in the scientific evaluation of their
patient profile, helping in analyzing the treatment results, and to plan treatment protocols. It
also helps in planning governmental strategies for future medical care. But of equal
importance in the present setting is in the issue of alleged medical negligence. 30 The legal
system relies mainly on documentary evidence in a situation where medical negligence is
alleged by the patient or the relatives. This would potentially mean that poor record keeping
by medical practitioners would amount to a poor defense in order to prove medical
negligence and no records would amount to no defense.

Furthermore, the Medical Council of India (Professional Conduct, Etiquette and Ethics)
Regulation, 2002 by the powers conferred under Section 20A of the Indian Medical Council
Act, 195631 issues guidelines in relation to proper maintenance of medical records. Under the
aforesaid regulations, regulation 1.3 stipulates that every physician shall maintain medical
records pertaining to his/her patients for a period of three years from the date of
commencement of treatment32, if there are any requests of medical records either by patients
or authorized attendant or legal authorities involved33, the same may be duly acknowledged
and documents are to be issued within a stipulated period of 72 hours and further stipulates
that efforts need to be made to computerize medical records for effective retrieval34.

4.1.1 Duration of Preservation of Medical Records

30
Joseph Thomas, ‘ Medical Records and Negligence’ (2009) 25 IJOU <http://www.indianjurol.com/article.asp?
issn=0970-1591;year=2009;volume=25;issue=3;spage=384;epage=388;aulast=> accessed 20 April 2020
31
S 20A- Professional Conduct- the Council may prescribe standards of professional conduct and etiquette and a
code of ethics for medical practitioners.
32
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, reg 1.3.1
33
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, reg 1.3.2
34
Indian Medical Council (Professional Conduct Etiquette and Ethics) Regulations, 2002, reg 1.3.3

18
As aforesaid, under the Medical Council of India Regulations, 2002 it is necessary to
preserve medical records for a minimum period of three years. 35 Hospitals may also have
their own policies on the duration of preservation of medical records but under the stipulated
regulations, 2002 a minimum of three years is a mandate. Section 24A the provisions of the
Consumer Protection Act, 1986 enumerates that a State or the National Commission shall not
admit a compliant unless it is filed within two years from the date on which the cause of
action arises. However, the section accounts for condonation of delay for filing consumer
complaints. An issue may arise with this regard. This would mean that medical
professionals / hospitals would not be obligated to effectively store medical records even if it
is required after a period of three years.

4.1.2 Ownership of Medical Records

An important issue of dispute between the patients and hospitals on the ownership of medical
records as to whether they are the property of the hospital. Thomas, argues that medical
records are the property of the hospital; this way they have the responsibility to maintain it
properly.36 The onus is on the hospital to make sure that the medical are not stolen,
manipulated, misused, etc. The current legal regime in India in relation to data privacy
addresses various obligations and effective penalty on persons having access to third party
data. This would be discussed in detail in the preceding part of this chapter.

4.2 TRANSPARENCY OF PATIENT INFORMATION/DATA

Globally, the information transparency has become the focal point in healthcare industry.
Patients need to have access to the prescribed treatment, records and medical history. 37
However, according to a medical practitioner,38private hospitals dominate healthcare
provisioning in India, so far, this sector has been almost completely unaccountable to its
users. “Private hospitals need to evaluate their performance in terms of patient satisfaction. A
report by KPMG39, India is at the second place from the bottom among 68 countries in a
health system transparency index. The report stresses that at India should create a system
where its mandatory for hospitals to put out health related information such as prescribed
35
Indian Medical Council (Professional Conduct Etiquette and Ethics) Regulations 2002, reg 1.3.2
36
Ibid 30
37
Laxmi Yadav, ‘Lack of Transparency in healthcare sector hampering patients’ ability to make informed
decisions’ (Pharmabiz, August 16 2018) <http://www.pharmabiz.com/NewsDetails.aspx?aid=110568&sid=1>
accessed 20 April 2020
38
Ibid
39
KPMG, ‘Healthcare in India: Current state and key imperatives: Review of National Health Policy 2015 draft
(2015) < https://assets.kpmg/content/dam/kpmg/in/pdf/2016/09/AHPI-Healthcare-India.pdf > accessed 22 April
2020

19
treatments, tests, diagnosis, tariffs, pricing and patient satisfaction in public domain while
protecting sensitive patient-related detail.

Furthermore, in the case of medical negligence, it becomes necessary for adequate

transparency of patient related information as the same is necessary to prove negligence of
medical professionals/ hospitals. Therefore, it becomes necessary for the legal regime in
relation to heath data to adequately provide for provisions wherein medical professionals/
hospitals are responsible for providing accurate and detailed medical records.

4.3 LEGAL REGIME IN INDIA IN RELATION TO HEALTH DATA

The Existing laws on health data in India is not designed to deal with scale of data and
sharing being proposed40. Under Section 43(A) of the Information Technology Act, 2000 and
the Information Technology (Reasonable Security Practices and Procedures and Sensitive
Personal Data or Information) Rules, 2011 framed under the aforesaid act, which govern data
protection in India, the fundamental requirement is for body corporate to have suitable
security measures in place. A failure to safeguard data for the lack of such measures will
require a body corporate to award compensation to the individual affected. The Information
Technology Act, 2000 and the Information Technology Rules, 2011 mentioned herein only
deal with the protection of data and do not account for the availability of record of the
information collected.

Furthermore, in the case of Manisha Priya Bhatia v. Government of Nct of Delhi 41 it was held
that

“The patient has a right to his/her medical records, which are rooted in Articles 19 and
21 of the Constitution of India, and the hospital authorities whether private or public, have a
duty to provide the same under the Right to Information Act, 1986, Medical Council Act,
1956 and world medical ethics. The Public Authority has to develop a time frame mechanism
of disclosure of medical records to patients or their relatives with safeguards for privacy and
confidentiality of patients”

Therefore, it becomes necessary to formulate regulations that effectively address the

transparency of medical data to patients and detailed book keeping of medical records.

40
Ikigai Law, ‘DISHA and the Draft PDP, 2018: Looking at the future of governance of health data in India’
(2019) <https://www.ikigailaw.com/disha-and-the-draft-personal-data-protection-bill-2018-looking-at-the-
future-of-governance-of-health-data-in-india/#acceptLicense> accessed 22 April 2020
41
Manisha Priya Bhatia v. Government of Nct of Delhi (2014) CIC/AD/A/2013

20
 CHAPTER 5: SUGGESTIONS AND CONCLUSION

The principle of res ipsa loquitur is only a rule of evidence and operates in the domain of civil
law especially in cases of torts and helps in determining the onus of proof in actions relating
to negligence. It cannot be applied in criminal negligence blindly and therefore plaintiffs have
to prove the case with essential evidence and since judges are not medicine experts, they have
to rely on the opinion of certain experts while dealing with medical negligence. But these
experts may not be objective and therefore, a balance must be struck. On the one hand,
doctors who are negligent have to be penalize and financial redress has to be given to
suffering patients. On the other, doctors are professionals too and might make an error in
judgement and indiscriminate proceedings are not good for the society.

It becomes necessary to formulate regulations that effectively address the transparency of

medical data to patients and detailed book keeping of medical records. The current regime
though provides for provisions that obligates the medical professional/ hospital to store
medical records for a minimum period of time, does not effectively address situations where
medical records might become necessary after the stipulated time period. Furthermore, the
current legal regime in relation to health data or data in general only accounts for measures to
maintain privacy of data and does not provide for providing a detailed record of all data
collected in any form. One probable solution to the issue could be maintaining the general
practice of digitization of medical records, this way, medical records could be made available
as and when required.

BIBLIOGRAPHY
Acts
Consumer Protection Act, 2019
Indian Penal Code, 1860

21
Information Technology Act, 2000
Indian Medical Council Act, 1956
Information Technology Act, 2000

Regulations
Medical Council of India (Professional Conduct, Etiquette and Ethics) Regulations, 2002

Rules

Information Technology (Reasonable Security Practices and Procedures and Sensitive

Personal Data or Information) Rules, 2011

Case Law
 Blyth v Birmingham Water Works Co(1856) LR 11 Exch. 781

Jacob Mathew v State of Punjab and anr AIR 2005 SC 3180

Donoghue v Stevenson (1932) A.C.562
Dr.LakshmanBalkrishna Joshi v Dr.TrimbakBapuGodboleAIR 1989 P and H 183
Spring Meadows Hospital v Harjot Ahluwalia AIR 1998 SC 1801
AchutraoHaribhauKhodwa and Others v. State of Maharashtra and Others AIR 1996 SC 2377

Bolam v Friern Hospital Management Committee, [1957] 1 W.L.R. 582, 586

Eckersley v. Binnie [1988] 18 Con.L.R. 1, 79

Dr.Akhil Kumar Jain v. Lallan Prasad2004;(II) CPJ 504.

Mam Chand v Dr. GS Mangat of Mangat Hospital 2004;(I) CPJ 79 (NC)
Smt. Vimlesh Dixit v Dr. R.K. Singhal2004;(I) CPJ 123
ManishaPriya Bhatia v. Government of Nct of Delhi (2014) CIC/AD/A/2013

Research papers
Terry H, 'Negligence' (1915) 29 Harvard Law Review 40

22
Rubsamen D, 'Res Ipsa Loquitur in California Medical Malpractice Law--Expansion of a
Doctrine to the Bursting Point' (1962) 14 Stanford Law Review 251

Thomas J, ‘Medical Records and Issues in Negligence’ (2009) 25 Indian Journal of Urology
384

Ilayanambi B, ‘Challenges Before Data Privacy Laws in India: With Special Reference to
Protection of Patients Information’ (2019) 1 Law Audience Journal 24

Rao SV, 'Medical negligence liability under the consumer protection act: A review of judicial
perspective' (2009) 25 (3) Indian Journal of Urology 361

Srinivas N & Biswas A, ‘Protecting Patient Information in India” Data Privacy Law and Its
Challenges’ (2018) 11 NUJS Law Review 409

Bhardwaj A & Singh K, ‘Medical Negligence in India: A Study with Special Reference to
Liability in Tort’ (2018) 3 International Journal of Academic Research and
Development 1415

Hyman D & Silver C, ‘Medical Malpractice Litigation and Tort Reform: It’s the Incentives,
Stupid’ (2006) 59 Vanderbilt Law Review 1085

Peters P, ‘Doctors and Juries’ (2007) 105 Michigan Law Review 1453

Duru O, ‘The Applicability of the Doctrine of Res Ipsa Loquitur Negligent Actions: A
Critical Appraisal’ [2012] Legal Emperors

Sreya B, ‘Consumer Rights and Medical Negligence’ [2013] NUJS Law Review

Books

Winfield and Jolowicz, Tort (18th edn, Sweet and Maxwell 2010) 45

RK Bangia, Law of Torts (23rd edn, Allahabad Law Agency 2013) 236

Blogs and Websites

Laxmi Yadav, ‘Lack of Transparency in healthcare sector hampering patients’ ability to make
informed decisions’ (Pharmabiz, August 16 2018)

23
<http://www.pharmabiz.com/NewsDetails.aspx?aid=110568&sid=1> accessed 20 April 2020

KPMG, ‘Healthcare in India: Current state and key imperatives: Review of National Health
Policy 2015 draft (2015) < https://assets.kpmg/content/dam/kpmg/in/pdf/2016/09/AHPI-
Healthcare-India.pdf > accessed 22 April 2020

Ikigai Law, ‘DISHA and the Draft PDP, 2018: Looking at the future of governance of health
data in India’ (2019) <https://www.ikigailaw.com/disha-and-the-draft-personal-data-
protection-bill-2018-looking-at-the-future-of-governance-of-health-data-in-
india/#acceptLicense> accessed 22 April 2020

24