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MEDICAL
JURISPRUDENCE
By
Dr Faiz Ahmad
Assistant Professor
MCI & SMC
CONSTITUTSION & FUNCTION
INTRODUCTION
MEDICAL PRACTITIONER means an individual who practices the art of
allopathic system of modern medicine.
REGISTERED MEDICAL PRACTITIONER (RMP) means Medical
Practitioner whose name appears in the official register kept for the purpose
in accordance with the law of the land to which one belongs.
The medical profession is governed by legislation(Law of the land) and
by a Code of Ethics and Etiquette.
The broad principles of medical ethics are formulated by National and
State Medical Councils and the World Medical Association.
The ethics are nothing but the moral principles that guide the members of
medical profession.
Thus the practice of medicine includes ethical practice within the legal
framework of the State (Country).
The enforcement is done by the Medical Council of India(MCI) and
State Medical Council(SMC).
INDIAN MEDICAL DEGREES ACT 1916
The Act was passed to grant the title in respect of the qualification of
western medical science.
According to the Act, we have right to grant medical degrees,
diplomas and certificates to practice the western medical science but
false use of a title is punishable under the Act.
Medical Council of India
In the year 1933, the Indian Legislative Assembly passed an Act known
as the Indian Medical Council Act 1933.
Now this Act stands repealed and in its place, the Indian Medical
Council Act 1956 is enacted with following particulars.
 To give recognition for representation of the licentiate medical
practitioners.
 To provide registration of foreign medical qualifications.
 To provide for formation of a committee to help in reorganizing
postgraduate medical education in the country.
 To maintain an “All India Medical Register” containing names of
Registered Medical Practitioner all over India.
Composition of Medical Council of India
Section 3 of the Act states that the medical Council of India (MCI) shall
consist of:
1. One member from each State, other than Union territory to be nominated
by the Central Government in consultation with the State government
concerned.
2. One member from each University to be elected from amongst the
members of medical faculty of the University by members of the senate
of the University or members of the court if there is no senate.
3. One member from each state, in which a state medical register is
maintained, to be elected from amongst themselves by persons
enrolled on such register.
4. Seven members to be elected from amongst themselves by persons
enrolled on any of the state medical register.
5. Eight members to be nominated by the Central government.
The President and the Vice-President of the Council shall be elected by the
members of the council from amongst themselves.
The President and the Vice-President shall hold office for a term not
exceeding five years and not exceeding beyond the expiry of term as a
member of the council.
The members of the council shall hold office for five years.
The council appoints a Registrar who acts as a Secretary for day to day
work of the council.
Dr B C Roy was the first Indian to be President of MCI in 1939.
The MCI carries out the purpose of Indian Medical council Act
through an Executive Committee and through such other committees,
as the council may deem necessary.
These committees are constituted from amongst the members of the
council.
Functions of MCI
Maintenance of Indian Medical Register
The Council maintains a register of medical practitioners, known as
the Indian Medical Register.
It contains the names of all persons who are enrolled on any State
Medical Register.
If the name of a person enrolled on a State Medical Register is
removed from the Register, the Council also removes such person's
name from the Indian Medical Register.
Regulation of standard of undergraduate and
postgraduate medical education
It maintains the uniform standard throughout the country in respect to
Undergraduate and Post Graduate courses.
There is a Post Graduate Medical Education Committee consisting of
nine members to maintain a uniform standard in respect to Post
Graduate Qualification imparted by different Universities.
They also advice the Universities and give guidance in this respect.
Prior approval of M.C.I. is required for starting a PG course in
any discipline. If not followed the M.C.I. has power to derecognized the
said qualifications.
As regards to Under Graduate Medical Education, the Council
prescribes minimum standard.
It appoints Medical Inspectors to inspect the various colleges before
giving sanction either to start a new college or to renew it.
Even to increase the numbers of seats in Medical College requires
M.C.I.’s prior permission.
The inspectors submit the report to the M.C.I. which is considered by
the committee formed.
Then the committee recommends to the Government to grant
permission or not.
In cases when the Council is not satisfied, it recommends the
Government to withdraw the recognition.
Recognition of Medical Qualification
The MCI recognizes medical qualification granted by
universities/institutions and maintains three schedules for recognition of
medical qualification. The schedules are as follows.
1. As per First schedule of the Act, medical qualifications granted by
recognized universities in India are recognized by council.
2. As per Second schedule, the medical qualifications granted by
institutions outside India are recognized by council.
3. Third schedule has two parts
As per part I of third schedule, the medical qualification granted by
institution of India but not included in first schedule.
Part II of third schedule recognizes those medical qualifications
granted by institutions outside India but not included in second
schedule.
Recognition of foreign medical qualifications
Indian National with foreign degree which is not included in the part II of
the third schedule applied to central government along with the full
information in respect of the syllabus and duration of course etc.
The Central Government forwards the applications to Indian Medical
Council which has authority to enter in negotiations with any of the Medical
Council of the Foreign Countries and can recognize such Qualifications.
Then the Central Government by official gazette notification may amend
the part II and includes such qualifications.
Appeal against Disciplinary Action
When name of any doctor is removed from the state medical register, he
may appeal to Central Government after exhaustion of all the official
remedies under the state medical council.
He should apply within 30 days from the date of decisions along with all
the relevant documents.
The Central Government will consult MCI and MCI then examines the
facts under inquiry and furnish its recommendations to Central Government.
The recommendations made by MCI are binding on the State Government
and the State Medical Council
Disciplinary Control
The MCI prescribes minimum standards for Registered Medical
Practitioner with reference to professional conduct, ethics and etiquette.
The MCI exercises disciplinary control over RMP.
The MCI can issue warning notices to its members for involvement in
unethical practices falling under the meaning of the term ‘infamous
conduct in a professional sense’.
Certificates
It is empowered to issue certificates of good conduct and character to
medical students/doctors going abroad for higher studies/service.
CME programmes
It sponsors and organizes continuing medical education (CME)
programmes for medical practitioners.
Faculty development programme
MCI has undertaken the task of training the medical college faculty
upto the level of Associate Professorsin MCI Basic Workshop in
Medical Education Technologies.
Faculty should undergo this training either before joining service or
during probation period and once every 5 years thereafter.
State Medical Council (SMC)
The State Medical Councils are autonomous bodies, established under
the State Medical Council Act.
Each of these Medical Councils consists of members elected by the
registered medical practitioners and those nominated by the State
Government.
The President and the Vice-President of the Council are elected by the
members from among themselves.
Functions of SMC
Maintenance of Medical Register
The Council appoints a Registrar, who keeps a Register of medical
practitioners.
On payment of prescribed fees, the name, address and qualifications are
entered in the register.
A provisional registration is granted to a student who has passed the
qualifying examination, but has to undergo a certain period of training
(internship for 1 year) in an approved institution, and permanent registration
is granted after that training period.
Additional qualification obtained subsequent to registration or for any
alteration may be done after payment of requisite fees to the SMC.
The Registrar should inform the Indian Medical Council without
delay, of all additions and other amendments in the State Medical
Register, made from time to time.
Disciplinary control
The Council is entrusted with disciplinary control over the registered medical
practitioner.
SMC can issue warning, suspension or penal erasure of the name of medical
practitioner found indulging in unethical practice, and advises them to conduct
themselves according to the ethical norms prescribed by the Council.
It can act against doctors for professional negligence too.
The SMC takes cognizance of any misconduct (professional) in case:
 Convicted by court for any criminal offence.
 A complaint has been lodged against him by some person or body.
Disciplinary functions of State Medical Council
Erasure of Name
The name of the doctor is removed from the Medical Register:
(1) After the death of the registered practitioner.
(2) Entries which are made in error or as a result of fraud.
(3) Penal erasure
Penal Erasure refers to removal of a medical practitioners name from
the medical register temporarily or permanently as a penalty.
Done when doctor is guilty of serious professional
misconduct(infamous conduct).
Doctor can not practice medicine till his name remains removed from
register.
If the name removed permanently, doctor can not practice for life.
This is known as PROFESSIONAL DEATH SENTENCE.
Cont…
Ethical aspects of medical practice
Medical Ethics
The word “ethics” is derived from “ethikos” which means manner and
habit of man.
Medical ethics deals with the moral principles, values and guidelines
that govern the conduct and relationship of doctor with his patients.
DOCTOR PATIENTS
In other words, medical ethics are the code of behaviour accepted
voluntarily within the profession.
Medical etiquette
Refers to the conventional laws of courtesy observed between members
of the medical profession.
DOCTOR DOCTOR
Violation of medical etiquette is NOT punishable under law
A registered medical practitioner is required to observe certain
prescribed rules of conduct contained in Code of Medical Ethics,
published by the Medical Council of India and by many State Medical
Councils.
Known as..
Indian Medical Council (Professional Conduct, Etiquette and
Ethics) Regulations, 2002 (amended in 2009, 2016).
These regulations are binding on all doctors registered with the Medical
Council of India/State Medical Council.
The regulations prescribed by the MCI contain eight chapters.
Chapter 1: Code of medical ethics.
Chapter 2: Duties of Physician to their patients.
Chapter 3: Duties of Physician in consultation.
Chapter 4: Responsibilities of physician to each other.
Chapter 5: Duties of Physician to the public and to the paramedical
profession
Chapter 6: Unethical acts
Chapter 7: Misconduct
Chapter 8: Punishment and disciplinary action
Code of Medical Ethics
At the time of registration, all the doctors are self-warned about certain
unethical practices (infamous conduct) and the disciplinary action by the
SMC (also called as warning notice).
The applicant should certify that he/she had read and agreed to abide by
the declaration and submit a declaration duly signed.
Declaration of Geneva (Physician’s Oath; modernized version of
Hippocratic Oath)
It was amended at Sydney in 1968.
I will solemnly pledge myself to consecrate my life to the service of
humanity.
I will give to my teachers the respect and gratitude which is their due.
I will practice my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confided in me, even after the
patient has died.
I will maintain by all means in my power the honour and the noble
traditions of the medical profession.
My colleagues will be my brothers.
I will not permit considerations of religion, nationality, race, party
politics or social standing to intervene between my duty and my
patient.
I will maintain the utmost respect for human life from the time of
conception; even under threat.
I will not use my medical knowledge contrary to the laws of
humanity.
I make these promises solemnly, freely and upon my honour.
Rights of a Registered Medical Practitioner
The rights are
(1) Right to choose his patient (EXCEPT IN EMERGENCY).
(2) Right to add titles, qualifications etc after his name.
(3) Right to practice and dispense medicines.
(4) Right to possess and supply dangerous drugs to his patients.
(5) Right to recovery of fees.
(6) Right to give evidence as an expert.
(7) Right to issue medical certificates.
(8) Right for appointment to public and local hospitals.
Duties of a Medical Practitioner
1. General duties and responsibilities
Dignity - Doctor should uphold the dignity and honor of his
profession.
Modesty - Should be modest, sober, pleasing in personality, should
have patience. Should be eager to help patients.
Knowledge - Should keep abreast of advances of medical science,
and improve his knowledge and skills by referring to latest books,
journals, attending conferences.
2. Duties of medical practitioners to their patients in particular
a. Duty to exercise a reasonable degree of skill and knowledge
b. Legal duty to render service
Doctor can withdraw treatment under following conditions
(i) Treatment is no longer required
(ii) Patient asks him to withdraw treatment
(iii) Mutual assent of both parties
(iv) After giving notice with a reasonable time for patient to find another
doctor
(v) Physician himself becomes sick
(vi) Patient is found to be malingering
(vii) patient is using remedies other than those prescribed by him;
(viii) patient ignoring his instructions;
(ix) patient seeing another doctor without informing him;
(x) patient is using contraband drugs, intoxicants or poisons;
(xi) patient not fulfilling his earlier financial obligations [not paying
fees]
c. Prognosis
Doctor should neither exaggerate, nor minimize the gravity of his
patient’s condition
d. Patient must not be neglected
e. Engagement for an obstetric case
If a doctor A who was engaged to attend to an obstetric case is absent,
and another doctor B is sent to conduct delivery, B is entitled for his
professional fees.
When A returns, B should leave the patient only after securing the
patient’s consent.
f. Duty in emergency
g. Duty to give instructions
h. Duty to inform and warn
i. Clearly display his fees and other charges on the board of his
chamber and the hospitals he is visiting.
j. Professional secrecy (confidentiality)
Professional secrecy refers to the doctor’s obligation to keep secret all
information regarding patient that he comes to know in the course of his
professional work.
It is an implied term of contract between doctor and patient.
Information can be divulged - with patient’s consent.
Situations when doctor should not reveal condition of patient
(i) Press conferences
(ii) Information to parents
Doctor can communicate illness of a minor or mentally ill person to the legal
guardians.
(iii) Information to third parties (Except privileged communication)
(iv) Husband and wife – Condition of one can not be told to the other.
(v) When free treatment is provided – Doctor still has to maintain
professional secrecy
(vi) Information regarding dead person
(vii) Reporting in a medical journal – may be revealed to readers, but
identity of patient must be hidden
(viii) Postmortem findings – should be revealed only to the police.
(5) Punishment for not maintaining professional secrecy
(i) u/s 499, IPC – defamation. Punishment for defamation is 2 years
(u/s 500, IPC)
(ii) Civil action for damages
(iii) He can complain to MCI/SMC, which can take disciplinary action.
k. Privileged communication
There occur some situations where the doctor has to divulge the
patient’s details to certain authorities.
This divulgence of the details is known as privileged communication
and is an exception to professional secrecy.
Situations where privileged communication holds true are..
In Society’s interest
In patient’s interest
In a third party’s interest
In doctor’s own interest
Court of law
Notifiable diseases
Suspected crime
Employers
Medical for insurance
Waiver of professional secrecy
3. Duties of RMP Towards Professional Colleague
Not to criticize colleague
Never take fees, should consider it a pleasure and privilege to render
gratuitous service to all fellow doctors and their family dependents.
Always help
Duties with regard to consultation.
 Ask for consultation only when it is required.
 Patient’s consent-talk about the same with the patient or his relatives and inform
about the reasons for the same.
 If they object, mention in the case records.
4. Duties of medical practitioners to the public in general and to the
paramedical profession
Duty to notify certain diseases
Duties to inform vital events
Should disseminate advice on public health issues.
Should co-operate with the authorities in the administration of
sanitary and public health laws and regulations.
5. Duties of medical practitioner in criminal matters
Section 39 of CrPC, RMP should communicate to the police any
information about a criminal act that has come to his knowledge.
Attempt to commit suicide (section 309 of IPC) is not included in
section 39 of CrPC. It is therefore not mandatory for RMP, doing
private practice, to supply such information of his own accord to
police or magistrate. However, he is duty bound to inform police if the
person happens to die.
section of 175 of CrPC, the doctor has to provide all the information if asked by
police or magistrate. Failure to provide or concealing of such information is
punishable under section 202 of IPC. Also charged under section 201 of IPC for
destruction of evidences and/or if doctor fails to discharge his duties to inform
police in time.
Preservation of trace evidences and samples (e.g. gastric lavage, blood etc.),
clothes, foreign bodies such as weapon, bullet/pellets etc. in an injured or
poisoning patient or sexual offenses cases should be done by doctor and handed
over to the police/investigating officer.
Preservation of record: The indoor patient’s record should be made and preserved.
PROFESSIONAL MISCONDUCT (INFAMOUS CONDUCT)
Professional misconduct (syn. Infamous conduct, ethical misconduct,
ethical negligence, ethical malpraxis) is that act of a medical man which
would be reasonably regarded as disgraceful or dishonorable by his
professional brethren of good repute and competence.
Professional misconduct should include only those actions for which
there are no punishments in IPC or in any other existing civil or criminal
law, yet MCI or SMC can take action.
List of Professional Misconducts
(1) Adultery or improper conduct or association with a patient.
(2) Conviction by court of law of offences involving moral turpitude.
(3) Issuance of false certificates, reports and other documents.
(4) Association with unqualified persons.
(5) Contraventions of drug acts and regulations.
(6) Selling a scheduled poison to the public.
(7) Performing an illegal abortion or enabling an unqualified person to
perform an abortion.
(8) Issuance of certificate of efficiency in modern medicine to unqualified or
non-medical persons.
(9) Contributing articles to the lay press and giving interviews regarding
diseases and treatments which may have the effect of advertising
himself or soliciting practice.
(10) Using an unusually large signboard. It is also improper to affix a
signboard on a chemist’s shop or in places where he does not reside or
work.
(11) Disclosing the secrets of his patients to others, except when
bound by law.
(12) Refusing treatment on religious grounds.
(13) Publishing photographs of his patient in any medical journal (by
which his identity could be made out) without obtaining the consent of
that patient.
(14) Publicly displaying his fees, except in his consulting room.
(15) Using touts or agents to procure patients.
(16) Receiving or giving commission or other benefits from fellow
doctors, traders, chemists, manufacturers etc. Giving of commission by
one doctor to another for favor of recommending or referring the patient
to him is known as dichotomy or fee-sharing or fee-splitting.
(17) Talking disparagingly about other colleagues or doing anything
that means unfair competition.
(18) Not attending a patient when he is already under his treatment.
(19) Addiction to narcotic drugs.
(20) Alcoholism.
(21) Using unsterile instruments, or not furnishing his patients with proper
information about drugs or diet.
(22) Covering i.e. assisting someone who has no medical qualification to attend,
treat or perform an operation on some person in cases requiring profession skill.
(23) Running an open shop for the sale of medicines.
(24) Writing prescriptions in a secret formula known to some particular pharmacy
only.
(25) Commercialization of a secret remedy.
(26) Accepting any gift or travel facilities etc from pharmaceutical companies.
The 6 A’s of Serious Professional Misconduct
(1) Association with unqualified persons – e.g. employment of touts to procure
patients.
(2) Advertising – It is improper to use an unusually large sign board to advertise
oneself.
(3) Adultery–arising out of professional relationship.
(4) Abortion (unlawful) – Unlawful abortion includes prenatal determination of sex
and then inducing abortion.
(5) Addiction – Addiction to drugs or doctor supplying drugs of addiction to addicts.
(6) Alcohol – Seeing patients under the influence of alcohol.
RIGHTS AND DUTIES OF PATIENTS
Rights and Privileges of Patients
1. Right to choose doctor
2. Right to access health care facilities available regardless of age, sex,
caste, religion, and economic or social status.
3. Right to be treated with dignity, with care, respect and without any
discrimination
4. Right to have privacy during consultation or treatment
5. Right to have confidentiality of all his information furnished to
doctor
6. Right to receive full information about the diagnosis, investigations
and available methods of treatment.
7. Right to know the procedure of operation, risk involved therein,
available alternatives, the type of procedure, and the safety of
procedure, results and prognosis.
8. Right to seek second opinion from another doctor
9. Right to demand for the medical record
10. Right to complain and rectification of grievances
11. Right to obtain compensation for medical injuries or negligence.
Duties of Patients
1. Duty of patient to furnish all information related with health to doctor
2. Duty of patient to follow the instructions/advice given by doctor
3. Duty to pay fees to the doctor
4. If the patient wishes to take second consultation or second opinion, the patient
should inform the first doctor
5. The patient should have faith in the doctor chosen for treatment
6. The patient should not contribute to medical negligence
7. The patient should co-operate with the Medical Practitioner for the necessary
laboratory investigations such as X-rays, ECG etc. because these tests may be
necessary for the diagnosis and proper treatment.
Infringement by doctors of patient’s rights
a. Paternalism
Paternalism [Gk. pater, father] is acting upon one’s own idea of what is best
for another person without consulting that other person.
PATERNALISM PATIENT AUTONOMY
Up to 19th century, paternalism was prevalent and legal. It is no more legal.
Paternalism (in a conscious, mentally sound, adult patient), although done in the
patient’s best interests, is illegal.
The doctor may be sued u/s 350, IPC [using criminal force].
b. Therapeutic privilege
Therapeutic privilege [TP] is the doctor’s privilege not to reveal to the patient that
part of the information about his illness, which he genuinely thinks would lower
patient’s morale and his will to live.
In order to save himself from later litigation doctor should
Obtain expert consultation that patient is really emotionally disturbed and
divulging information may cause more harm.
Report of that consultation must be attached to the case sheet
Record in patient’s case sheet what he not disclosing and why
As far as possible, information should be told to patient’s spouse or next of kin.
Abuse by patients of their rights
Malingering
Malingering or shamming is conscious planning, feigning and
pretending a disease for the sake of some advantage.
Malingering is done by people to have following advantages:
by workmen to claim compensation.
by policemen or military people to prevent hard postings.
by prisoners to avoid hard labor, or capital punishment.
by govt. servants to prevent transfers.
by businessmen to avoid contracts.
by beggars to attract public sympathy.
M/L Importance
(i) If the patient gets a medical certificate by narrating false symptoms,
and uses it for any purpose, he may be sued u/s 198, IPC
[punishment 7 y+fine]
(ii) Cheating – May be sued u/s 415, IPC [cheating].Punishment 1 y or
fine or both [S.417, IPC]
(iii)Must be differentiated from perjury. Malingering is not perjury, as
patient does not speak a lie under oath.
Cont…
PROFESSIONAL NEGLIGENCE
Professional negligence, medical negligence or malpraxis is absence
of reasonable care and skill, or willful negligence of a medical
practitioner in the treatment of a patient, which causes injury or death of
the patient.
Alternative definition - doing something that one is not supposed to do
[act of commission] and failing to do something that one is supposed to
do [act of omission].
Reasonable care also called “due care”
(a)Includes such reasonable care and attention that the patient may require.
(b)Must anticipate and appropriately manage known, expected or foreseeable
events and complications of patient’s disease and treatment
(c) It should be proportionate with
(i) Qualification of doctor
(ii) Known inability of the patient to take care of himself – unconscious
patient requires higher level of care and attention than a conscious
patient.
Reasonable care is breached in 2 situations
(a) When doctor unjustifiably deviates from accepted methods,
practices, procedures and treatments.
(b) When he used accepted methods but does so unskillfully.
Free service - Doctor provided free medical service " injury or death of
patient occurred " doctor still liable to be prosecuted under criminal law,
but cannot be made to pay compensation.
Components of medical negligence
For a case of medical negligence to be established, the following components
must be present (4Ds).
1. Duty-The doctor begins to owe a duty towards a patient
As soon as he agrees to treat him.
When he is in emergency. A doctor-patient relationship is established at
that point in time.
Doctor-patient relationship is not formed when patient is not in emergency
and the doctor did not agree to treat the patient.
2. Dereliction of duty
Once the presence of duty has been established, there has to be a
dereliction of duty on the part of the doctor, i.e. the doctor should have
been negligent in performing his duties towards the patient.
3. Damage
The damage must occur as a result of dereliction, and it must be
foreseeable.
Even if doctor is negligent, patient cannot sue him for compensation,
if no damage has occurred. He can however be sued criminally u/s
336, IPC.
Some examples of possible damages are
 Aggravation - of a preexisting condition
 Diminishing patient’s chances of recovery
 Expenses incurred
 Pain and suffering – causing either physical or mental [embarrassment,
fright, humiliation] pain or increasing it
 Loss of earning
 Loss of potency
 Prolonging his illness
 Reduced enjoyment of life – eg loss of a limb or sense
 Reduction in expectation of life
 Death
4. Direct causation
Damage must result directly from dereliction [proximate cause], and
not from any other cause.
Proximate cause refers to a cause, which in natural and continuous
sequence, unbroken by any efficient intervening cause, produces the
injury, and without which the injury would not have occurred.
Types of Negligence
1. Medical negligence
a. Civil negligence b. Criminal negligence
2. Patient negligence
3. Contributory negligence
4. Composite negligence
5. Corporate negligence
a. Civil negligence (Civil Malpraxis)
Civil negligence is said to occur when patient demands monetary
compensation for the damage that he has suffered due to the doctor’s
negligence. Civil negligence comes under tort law.
Salient features of Civil negligence
1. Question of civil negligence also arises - When patient refuses to
pay doctor’s fees alleging negligence, and doctor brings a civil suit
against patient to recover his fees.
2. Court - The case goes either to civil court or to consumer forum
3. Punishment - The doctor only has to pay whatever compensation the
court decides. There is no criminal liability for him and he cannot be
sent to jail for his action.
4. Additional punishments - However if the patient complains to
medical council also, it can take action against the doctor and can
punish him accordingly.
5. Standard of proof – It is the duty of the patient to prove negligence.
6. Defenses
(i) Informed consent
(ii) Contributory negligence
b. Criminal negligence (Criminal Malpraxis)
Criminal negligence is that when patient complains to the police
regarding the misconduct of the doctor, and the police registers a case
against the doctor.
Salient features of Criminal negligence
1. Who fights the case - State i.e. the government fights the case against the
erring doctor.
2. Punishment - The doctor is prosecuted under the various sections of the
Indian Penal Code (IPC) and if found guilty the doctor is liable to pay
damages as well as can be sentenced to a term in the prison.
3. Standard of proof - In criminal negligence - in contrast to civil
negligence the burden of proof that is required to prove the guilt is
“beyond reasonable doubt”. There should be >99% probability of the
doctor being guilty.
Classification of Criminal negligence
(1) When no injury to the patient occurs (S.336, IPC)
Negligent action but no injury " Patient cannot claim compensation, but
he can still lodge a criminal complaint against him under S.336, IPC.
If the doctor’s conduct was so rash or negligent as to endanger patient’s
life or his personal safety. Punishment is imprisonment of 3 months, or
`250 fine, or both.
(2) When injury occurs to the patient
When hurt is caused to the patient (S.337, IPC)
Negligent action Patient suffers hurt.
Punishment is imprisonment of 6 months, or `500 fine, or both.
When grievous hurt is caused to the patient (S.338, IPC)
Negligent action Patient suffers grievous hurt
Punishment is imprisonment of 2 years, or `1000 fine, or both.
When death is caused (S.304A, IPC)
Negligent action Death of patient .
The punishment is imprisonment of 2 years, or fine (any amount) or
both.
2. Patient negligence
Patient negligence is outright negligence by patient only. Doctor is not
negligent.
Salient features
Doctor is not liable in such cases.
Examples
(i) Patient does not give correct history
(ii) Starts an alternative form of treatment without informing doctor
(iii) Does not follow doctor’s instructions.
(iv) Discontinues treatment
(v) Refuses to take treatment
(vi) LAMA – leaving [hospital] against Medical advice.
3. Contributory negligence
Contributory negligence is the name given to a situation, where both
doctor and the patient are negligent.
Examples
Doctor applies tight plaster cast on patient’s leg [doctor negligent], but
instructs him to report numbness " Patient develops numbness in his
toes " does not inform doctor [patient negligent] " suffers permanent
injury " Doctor entitled to the defense of contributory negligence.
Doctor prescribes drug " fails to inform the patient of its side effects
[doctor negligent] " patient starts getting side effects " fails to inform
the doctor [patient negligent] " suffers injury “ contributory
negligence.
Burden of proof – lies with the doctor
Doctrine of comparative [or proportionate] negligence - Quantum
of injury caused by patient’s and doctor’s negligence is decided by the
court and the compensation awarded accordingly. If, say, patient’s
negligence is responsible for 80% of his injury, and doctor’s
negligence for 20%, patient would be entitled only to 20% of the
compensation.
Contributory negligence is a good defense in civil cases, but cannot be
taken as a defense in criminal cases.
Exceptions of contributory negligence
Last clear chance doctrine
Both doctor and patient are negligent. But if it is shown that the
defendant (doctor) had a “Last Clear Chance” to avert the damage
caused to the patient, and he did not avail of this chance, he loses his
defense of contributory negligence.
Example
Doctor prescribes drug to patient " fails to inform of side-effects [doctor
negligent] " Patient develops rashes, but fails to inform doctor [patient
also negligent, so concept of contributory negligence comes into play] "
Patient visits doctor on the next date " doctor sees rashes " fails to take
remedial action " Patient suffers injury " sues doctor " Doctor takes plea
of contributory negligence.
Analysis
Patient can allege that the doctor had the “last clear chance” to avoid
injury, because on the patient’s next visit, the doctor did see his rashes
and yet did not do anything.
The Avoidable Consequences Rule
Both parties are negligent, but patient could have avoided his own
injuries by being more careful [It is in fact a variation of the Last clear
chance doctrine” in as much as he himself had the “last chance” to avoid
injuries].
He could have avoided the consequences of doctor’s negligence, but he
did not carefully act upon it. So he himself is responsible for his injuries
and doctor need not to pay.
Example
Doctor does not apply bandage and antibiotics to a gaping lacerated
wound (doctor negligent) " He however advises the patient not to
allow the wound to get contaminated, and visit him next week to get
his wound examined again “.
Patient comes home and thinks that applying cow dung would heal his
wound faster " applies cow dung on his wounds " develops pus, but he
does not contact the doctor. Nor does he visit the doctor next week, as
was advised by the doctor (patient negligent) " Patient suffers injury.
Analysis
Here both doctor and patient are negligent and normally the
compensation should have been shared between the doctor and the
patient.
But since the patient aggravated his own injury by doing something
which was avoidable, the doctor would be covered under the
“avoidable consequences rule” and he does not have to pay anything.
4. Composite negligence
Composite negligence is said to occur, when a patient suffers injury as a
result of the combined negligence of two or more doctors.
5. Corporate negligence
Corporate negligence is the negligence of a corporation [hospital]. The
individual doctor may or may not necessarily be liable in this case.
Under the doctrine of corporate liability, a corporate house or hospital may
have a duty to properly select the persons of professional competence.
The hospitals may even be duty bound to intervene actively where a
physician is negligent and prevent errant staff from endangering
hospitalized patients.
To prove a charge of corporate negligence, the plaintiff would have to show
that the hospital was aware that the physician associated with the hospital
was providing sub-standard care.
Cont…
Important Concepts Related to Medical Negligence
Vicarious liability
Vicarious liability[vicarious responsibility] means that a person is liable
for the wrongful acts or omissions of another.
Salient features
Respondeat superior- [let the superior reply]
Vicarious liability arises under the principle of respondeat superior.
The employer is responsible not only for his own negligence but also
for the negligence of his employees, if such acts occur in the course of
the employment and within its scope.
Also known as “captain of the ship” doctrine.
RS becomes applicable when the superior had the “right, ability or
duty to control” the activities of a violator.
RS is the principle, while VL is the liability it puts on a superior.
RS principle ensures that employers engage the best possible talent in
their hospital.
Preconditions
There must be an employer – employee relationship
Employee’s conduct must occur within the scope of his employment [i.e.
employee did what he was legally supposed to do]
It should occur while on the job.
Compensation
Both the negligent doctor as well as his employer may be asked to compensate
patient by the court.
Employer may engage in a separate “third party proceeding” to recover money
from the negligent doctor.
Relationships when one is vicariously responsible for the negligence of other
Senior doctor - responsible for negligence of junior doctor, resident, intern
or an assistant working under his supervision
Hospital – responsible for negligence of its doctor
Two or more doctors working in partnership –each is responsible for
negligence of other
Two or more doctors attending on a patient independently – each may be
held liable for the negligence of other, if negligence produced symptoms
and signs which an ordinary doctor should have noticed and objected to.
Doctor referring his patient to an incompetent doctor knowingly
Referring doctor is vicariously responsible for negligence of
incompetent doctor.
Doctor writing illegible prescription and pharmacist dispensing wrong
drug – doctor is vicariously liable.
Doctor instructing prescription over telephone and pharmacist
dispensing wrong drug – doctor vicariously responsible
When an employee has been temporarily borrowed from another
Relationships when one is not vicariously responsible for the negligence of
other
Surgeon and anesthetist
Qualified nurse acting independently, not under the direct supervision and control
of doctor – doctor not vicariously responsible
Doctor referring his patient to a competent doctor – referring doctor not
responsible.
Doctor referring an already injured patient due to his negligence to a new doctor
or hospital – the latter is not vicariously responsible
Doctor writing clear, legible prescription and pharmacist dispensing wrong drug –
doctor not liable
Borrowed servant doctrine
Borrowed servant doctrine states that if an employee is temporarily
borrowed by an employer from the principal employer, then the
temporary new employer becomes vicariously liable for any negligent
act done by the employee.
Lending employer temporarily surrenders control over the employee.
The new master gains control over the employee and directly
supervises the employee and can give orders to him.
The new master is responsible for the actions of hired employee
[borrowed servant] only as long as he is under his direct supervision.
After the employee is returned, the original employer becomes
responsible for his negligent actions again.
Example
Resident [R] works on a regular basis in a private hospital [H]. An
independent private specialist [S] hires an OT in H and also services of
R " R commits an act of negligence when he had been hired by S "
Although R is a regular employee of H, the latter is not vicariously
responsible; S is vicariously responsible, because negligence occurred
when R was in direct supervision of S.
Res ipsa loquitur
Ordinarily the professional negligence of a doctor must be proved by the
patient.
Res ipsa loquitur [the thing or fact speaks for itself] is an important
exception to this rule, because here the professional negligence is so
glaring and obvious that it speaks for itself.
Conditions to be satisfied before this rule can be legally applied
Injury to the patient would not have occurred in the absence of
negligence.
Doctor had exclusive control over the injury producing instrument or
treatment.
The patient was not guilty of contributory negligence.
How proved
Generally without expert medical evidence. Common knowledge or
experience of a layman should be enough to understand and appreciate
that the negligence must have caused the injury [“Doctrine of common
knowledge” or “Common knowledge doctrine”].
Applicable
To both civil and criminal negligence.
Doctrine of common knowledge
Doctrine of common knowledge” states that when negligence is of such
obvious nature that even a layman with ordinary common knowledge
having no technical expertise can appreciate it, then evidence of a
medical expert to prove negligence is not required.
Examples
Antiseptic – Failure to apply to an open cut
Anti tetanus serum – failure to give in cases of gross injuries. Patient developing tetanus.
Artery forceps, swabs etc - left in the abdomen.
Blood transfusions –mismatched
Breaking of needles
Burns
from cauterizing tool at unintended places
from application of hot water bottles for excessively long time
from negligent application of X-ray therapy
Fluids – failure to give in obvious dehydration
Giving poisonous medicines recklessly
Prescribing overdose of medicines
Prolonged splinting; too tight a bandage or plaster – loss of use of a limb
Wrong amputation – eg right leg [eye, kidney etc] has been amputated instead of the left
Wrong teeth removed
Wrong person -operated upon.
Defenses Against Negligence
1. Actual denial
The doctor denies his responsibility straightaway and that he discharged
his duties according to the prevailing standards.
His records should be proper and complete to prove this assertion.
2. Calculated risk doctrine
Calculated risk doctrine [syn, doctrine of professional medical
judgment] asserts that doctor is not liable if he took a reasonable and
calculated risk to save life of patient and in the process patient suffered
injury.
Medical profession is a highly risk prone area and treatment often
involves a calculated risk.
If a physician chooses a course of treatment for a patient within a
range of medically accepted choices, after a proper examination and
evaluation, the calculated risk doctrine will insulate him from liability.
To impose liability, a plaintiff must show that the doctor’s decision
was something that fell below the certified medical determination.
What doctor must prove
He must produce expert evidence or statistics that the line of treatment he
chose was a medically acceptable procedure under the conditions, and that it
had unavoidable risks.
Examples
ADR to penicillin, streptomycin, IV antibiotics.
Immunizations of all sorts, blood transfusions, X-ray dye studies.
Injections into the spinal canal, injections of gold for rheumatoid arthritis,
and injections of cortisone directly into the joint.
3. Contributory negligence
4. Emergency
In emergency doctor may take some drastic measures to save life, which
may cause injury e.g. fracture of ribs during cardiac massage. Falls
under calculated risk doctrine also.
5. Law of limitation
Law of limitation specifies that a claim for compensation can be
brought against a doctor within a specified period. If the claim is
brought after that period, the doctor can take the defense of limitation.
The patient must file a complaint within a period of 2 years of
discovery of alleged negligence.
6. Medical misadventure
Medical misadventure [Medical maloccurrence] is defined as a bad or
undesirable outcome that is unrelated to the quality of care provided.
It is an unintentional and unforeseen accident, disaster or mischief,
which occurs due to individual biological variations.
7. No duty owed towards the patient
If the doctor had not agreed to treat patient, no duty exists.
8. Novus actus interveniens
Novus actus interveniens [an unrelated act intervening] refers to a
situation, where the doctor has been negligent, but a completely
unexpected and unforeseen act happened which further worsened the
patient’s condition.
The new act intervening should be completely unexpected and
unforeseen. Sometimes referred to as an “Act of God”.
Breaks the chain of causation between the act of negligence and the
resulting damage. Thus injury no more remains a proximate cause of
doctor’s negligence.
9. Patient negligence
10. Res judicata
Res judicata is a Latin term meaning “the thing has already been
decided”. Also known as the “doctrine of double jeopardy”.
If a question of negligence against a doctor has been decided in one
court, the patient cannot start another proceeding in a different court.
Appeal to the higher court however is allowed.
11. Volenti non fit injuria
Volenti non fit injuria [, to a willing person, injury is not done] is a
legal doctrine which means that if someone willingly places himself in
a position where harm might result, he will not be able to bring a claim
against the other party.
For this claim to succeed the doctor must show that an informed
consent had been taken and all side-effects had been explained,
12. Countersuits by doctors
Doctor files a countersuit against the patient. Should only be resorted
to when the doctor is absolutely sure there was no fault and the litigation
is frivolous.
Cont…
CONSENT IN MEDICAL PRACTICE
Consent is defined as free and voluntary agreement, compliance or permission
given for a specified act or purpose.
Indian Contract Act, 1872
(i) S.13 - Two or more persons are said to consent when they agree upon the same
thing in the same sense. Patient must understand, what it is given for and what
are the risks involved
(ii) S.14 - Consent is said to be free and voluntary when it is not obtained by
coercion, undue influence, fraud, misrepresentation, mistake and from mentally
unsound person.
Components of a legally valid consent
Patient >12 y [for general physical examination]; >18 y [for surgery].
In case of child, consent from guardian who should be >18 y
Patient understands that he can either agree or refuse to submit to
examination, diagnosis and treatment.
Has been provided full information on his disease and treatment
options.
Consent should be clear, direct, free, informed, intelligent, personal and
voluntary
(a) “Clear” in unambiguous words
(b) “Direct” directly conveyed to the doctor by patient, with no intermediaries.
(c) “Free” without undue force
(d) Informed
(e) “Intelligent” patient should have clearly understood the implications of
treatment. No ambiguity. No communication barriers
(f) “Personal” Doctor should not communicate to anyone, what the patient has
consented for
(g) “Voluntary” of his own accord.
Consent of an arrested person at police request – not necessary u/s 53,
CrPC.
Consent of an arrested person at his own request
u/s 54, CrPC, mandates compulsory medical inspection in all cases of
arrest by the police.
A copy of the medical report is to be provided to the arrested person or his
nominee.
If the arrested person is a female, her examination can be done only by or
under the supervision of a female doctor.
Consent of victim in criminal cases – In victims of assault, rape and in
cases involving pregnancy, abortion and delivery, examination of victim
is necessary to gather evidence of crime. However if victim does not
consent to examination it cannot be done.
Consent of spouse Legally required for
(a) Receiving artificial insemination.
(b) Donation of ovum or sperm.
Legally not required but desirable to avoid marital conflict later
(a) MTP
(b) Sterilization
(c) Any operation that can affect sexual life [breast reduction, penectomy,
penis transplantation ]
S.87, IPC - It is not meant for doctors, because the act done by
perpetrator is not done for the benefit of the opposite party.
(i) It is applicable to people who undertake risky activities.
(ii) To participate in a risky activity, the consenting person must be >18
y.
(iii)The act by the perpetrator must neither be intended, nor known to be
likely to cause death or grievous hurt.
S.88, IPC - It is meant for doctors, because the act done by perpetrator
is done in good faith for the benefit of the opposite party.
(i) It is applicable to doctors
(ii) The consenting person must be >12 y [S.90, IPC].
S.89, IPC - Act done in good faith for benefit of child <12 y or a person
of unsound mind, by consent of guardian – is not punishable.
What makes consent valueless – Consent given
(i) Under fear of injury
(ii) Under a misconception of fact
(iii)Consent of mentally unsound person
(iv) Consent under intoxication
(v) Consent of child <12 y [S.90, IPC]
S.52, IPC - Definition of “Good faith” — Nothing is said to be done or
believed in “good faith” which is done or believed without due care and
attention.
Loco parentis [in place of parent] – In emergency if parents are not
available, person in charge of child [e.g. a school teacher, a hostel warden]
can give consent.
Inmate of jail, hostel etc. refuses treatment, and he is likely to spread
disease - he can be forcibly administered treatment. Inmate of a hostel may
be asked to leave hostel.
In state mandated national programs – e.g. pulse polio, vaccinations, no
consent is needed.
Consent for illegal acts [e.g. criminal abortion] – is invalid.
Consent is not a defense – in cases of professional negligence.
Discharge against medical advice – If a patient wants to leave against
medical advice [LAMA], the dangers should be explained clearly in writing;
then his wish should be recorded in the case sheet and his signatures obtained.
Patient can then be discharged. In the discharge certificate, the doctor should
specifically write the dangers of leaving hospital against medical advice.
Kinds of Consent
According to information provided to patient
Uninformed consent -information completely or partly held back from patient.
Illegal unless it falls within the concept of “therapeutic privilege”
Informed consent
According to the way patient communicates it to the doctor.
Implied
when patient’s actions imply consent. Here the consent is presumed (i.e. implied).
[eg, telephoning, SMSing or emailing a doctor and asking for advice.]
The consent is not written but legally it is effective
The consent is provided for medical examination such as inspection,
palpation and auscultation. It does not cover the consent for
examination of
# Private parts
# Vein puncture or injection
# Major intervention or operation.
Express
When patient specifically consents to examination either verbally or in
writing.
In other words, an expressed consent is one, which is stated, in distinct
and explicit language.
Required – in all procedures beyond routine physical examination
[biopsies, Blood transfusions, LP, operations, Pleural and peritoneal tap
etc] and must be taken before the act; not after it.
A. Oral (verbal) consent
It is consent, which is given verbally.
This method is employed for minor procedures.
Consent should be obtained in the presence of a disinterested third party for
example nurse or receptionist
Oral consent, when properly witnessed, is of equal validity that of written consent.
Whenever oral consent is taken, it is appropriate to make an entry in the patient’s
clinical record.
Such precautions taken may be of use in future if any action is brought on the
doctor by patient.
B. Written Consent
Here the consent is obtained in a written format.
The doctor should explain the type of therapeutic procedure or
surgical operation properly to the patient.
Written consent afford documentary evidence
When such consent is obtained after explaining the nature and
consequences of the treatment procedure being contemplated, is called
as informed consent.
Miscellaneous kinds of consent
Blanket consent – is one where the doctor takes consent from the patient for any
and every possible diagnostic or treatment procedure that might have to be
undertaken any time in the future.
Since doctor himself is not sure of the kind of treatment that might be undertaken,
patient cannot be explained of its risks etc.
Many nursing homes and private hospitals, take blanket consent in the following
manner “I hereby authorize staff of this hospital to perform any surgical or
anesthetic procedure on me.”
Blanket consent is invalid in the eyes of law.
Proxy consent [substitute consent, surrogate consent]
Consent given by a relative, next of kin or friend in case the patient
himself cannot give consent [child <12 y, mentally unsound person,
intoxication, unconsciousness etc.]
Informed Consent
Informed consent means that consent of patient for any procedure or
treatment can only be taken after fully informing him about the nature
of his condition.
Components of an informed consent
Disclosure
Comprehension
Absence of any outside control
Competence
Actual consent
Disclosure Patient must be told
(i) Nature - of his disease
(ii) Options available – All treatments, costs, risks, benefits, success and failure rates,
after-effects and prognosis of each
(iii) In case of surgery
(a) Whether it would be done under local or general anesthesia
(b) Possible harmful effects of anesthesia
(c) Details of operative procedures, relative benefits and risks
(d) costs of each procedure
(iv) Risks - of not receiving any treatment.
Comprehension - Language - Explanation must be done in patient’s own
language. If need be, an interpreter may be employed.
Absence of any outside control over the decision– doctor, nurse,
paramedical staff or any relative must not influence the decision. If patient
voluntarily asks for advice, it may be given.
Competence
 patient should be above age of consent [>12y for GPE; >18 y for surgery
 should be mentally sound
 Should not be under influence of alcohol or drugs.
Actual consent Written and witnessed - To make it legally acceptable,
(a) Everything explained must be reduced to writing
(b) Signatures of patient obtained
(c) In presence of two independent witnesses to prevent any allegation
that the consent was forged or obtained under compulsion or pressure.
Principles which form the basis of informed consent
Principle of full disclosure or patient’s right to truth.
Principle of patient autonomy.
Principle of full disclosure states that a doctor should reveal all information to the
patient, regarding his disease, treatment options etc.
Withholding information from a competent patient is a violation of the doctor’s
role as a fiduciary and is not justified.
Exceptions
Doctor need not disclose risks of which he is himself unaware
If the risk is so obvious that a person with normal intelligence can easily
understand
Therapeutic privilege
Exceptions to informed consent
Emergency [S.92, IPC].
Exactly same provisos apply for mentally unsound, intoxicated, persons
<12 y and persons otherwise incapable of giving consent.
Example
Patient consents to laparotomy " during operation doctor discovers an
unanticipated condition which endangers the life of patient " patient is under
anesthesia " consent for the new operation cannot be taken " doctor
undertakes procedure " protected u/s.92, IPC.
This exception however does not extend to causing death.
Example
Doctor finds a lesion which would cause excruciating pain to patient, and he
is sure, the patient cannot live for more than 6 months with the lesion. He
decides to commit euthanasia to save unnecessary suffering. It is illegal.
Therapeutic privilege
Waiving of rights by patient – Patient expressly waives his right to
informed consent to doctor.
Informed Refusal
The concept of informed refusal states that the doctor must inform the
patient about the risks of refusing a particular operation, test, medication, or
other medical intervention.
Concept of informed refusal is inherent in informed consent
It assumes importance only when the patient does not consent to treatment
despite being informed of risks of refusal.
To be legally valid, such informed refusal must be reduced to writing with
signatures of patient, doctor and witness.
Doctors and medical records
Medical record [Health record, medical chart] is a document which
records, documents and chronicles patient’s history, medical
examination, laboratory and ancillary investigations, treatment advised,
operation notes, discharge summary, details of subsequent visits and any
other data regarding patient treatment.
What Constitute Medical Record?
OPD cards
IPD cards
Details of provisional and final diagnosis
Treatment record
X-ray films/USG report/CT scan/MRI films
Laboratory reports
Discharge and follow up record
Medical Record is Required for Patients
For claim of medical negligence cases
For life insurance policy purpose
For third party claims under health and accident insurance
As a proof of disability
Workman’s compensation cases
Traffic accidents cases
Follow-up cases or taking treatment from another doctor
Medico-legal cases
Medical Record is Required for Doctors/Hospitals
For medical research
For cost accounting
Hospital audit
Evaluation of drug therapy
Planning
Legal purpose
Administration
Follow-up cases
Insurance claims
Features of MR
The medical record should be adequate, appropriate and complete.
The patient or the representatives have got the right of access to their
medical record.
Well-maintained medical records will help the doctors and the
hospitals to defend in medical negligence cases.
MCI and Medical Record
Indian Medical Council (professional conduct, etiquette and Ethics
Regulations, 2002 (chapter 1, Section 1.3, subsection 1.3.1 and 1.3.2)
states that:
Every physician shall maintain the medical records pertaining to
his/her indoor patients for a period of 3 years from the date of
commencement of the treatment in a standard proforma lay down by
the MCI.
If any request is made for medical records either by the
patients/authorized attendant or legal authorities involved, the same
may be duly acknowledged and documents shall be issued within the
period of 72 hours.
Failure to maintain medical records for a period of three years or
refuses to provide the same within 72 hours to the patient or his
authorized representative will amount to misconduct.
PRODUCTS LIABILITY
Products liability occurs, when a manufacturer supplies a defective
medical instrument or gadget (product) to the doctor or hospital; doctor
inadvertently uses the defective product causing injury to the patient.
Instances when product liability occurs
Instruments
Faulty, defective or negligently designed medical or surgical instruments
[e.g. a defective defibrillator]
wrong or inadequate operating instructions
Medicines
Components are incorrectly listed
Potency too low or too high
Wrong instructions of taking medication, e.g. oral medicine instructed to be
instilled in eye
Defective prosthetic devices
Artificial heart valves, limbs etc.
Pacemakers
Legal duties of manufacturer
(i) To use due care and research in development of all medical
products, including medicines, medical and surgical instruments etc
(ii) To perform studies of its product, when adverse reactions are
reported in articles in scientific journals, and to report the results of
these studies to physicians.
When is manufacturer liable
(i) Almost always, unless doctor used the instrument incorrectly
(ii) With respect to medicines if harm was caused due to adulteration,
contamination, incorrect dosage or wrong labeling of drug.
When is doctor liable
If the instrument functioned satisfactorily during previous operations.
Incorrect use – by doctor.
Wear and tear – occurred in the instrument either due to normal wear and
tear, or due to mishandling by doctor or paramedical personnel.
If the instrument was out of warranty, and required periodic inspection,
testing and repairing and no request was sent to manufacturer for this.
If instrument required periodic servicing and it was not sent for servicing.
If doctor knew [or should have known] the dangerous side effects, and
could have used a substitute drug, yet decided to use the dangerous
drug for no plausible reason.
If manufacturer has provided information in “package insert”, but
doctor failed to convey it to patient. Once the manufacturer has made a
warning in this manner it is the duty of doctor to convey this warning
to the patient. Manufacturer has no duty to ensure that such warnings
in the “package insert” reach the patient.
MEDICAL INDEMNITY INSURANCE
Medical Indemnity Insurance [Medical Malpractice Insurance] is a
contract between the doctor and an insurance company, under which the
latter agrees, in exchange for the payment of premiums, to indemnify
[reimburse or compensate] the insured doctor against claims resulting
from his professional negligence.
Objects of MII
To look after and protect the professional interests of the insured doctor.
To arrange all other professional assistance including pre-litigation advice.
To arrange, conduct and pay for the defense of such doctors.
To indemnify the insured doctor arising from actions, claims and demands
against him on grounds of professional negligence, misconduct, etc.
When any dispute or allegation of negligence arises, the society must be
contacted.
MEDICOLEGAL ASPECTS OF HIV AND AIDS
A. Civil
Discrimination
HIV+ve person can not be isolated, quarantined or discriminated against.
Divorce
U/s S.13(1) of Hindu Marriage Act, 1955, a person can get divorce, if spouse has been
suffering from venereal disease in a communicable form.
Employment
According to India’s National Policy on HIV/AIDS, a person can neither be denied
employment because of his HIV+ve status, nor can he be discriminated during service,
nor can he be terminated from job solely due to HIV+ve status.
B. Criminal
Marriage or intercourse
HIV +ve person A knowingly marries B [or performs intercourse] without
informing B of his status " B catches infection " A can be sued u/s 269, IPC.
S.269 may apply when the accused
(a) Did not know he was HIV+ve
(b) Did not understand how HIV is transmitted
If accused disclosed his HIV+ve status to the person at risk [or honestly believed
the other person was aware of his status], there may be no case.
C. Rights of HIV+ve Patients
An AIDS patient has the right to life and personal liberty [Art 21, Constitution of
India]. It means that he has the right to treatment of his disease like any another person.
They have the right to privacy. It means that they have the same right as other patients
with regard to the disclosure of their disease status to other people and general public as a
whole.
In other words, one (doctor or hospital) can’t do things like putting labels on their beds
indicating their HIV status.
They cannot be isolated or quarantined on the basis of their disease.
They cannot be discriminated in any sphere of life, including their job, due to their HIV
status.
D. Duty of Doctors
Confidentiality
Normally a doctor must maintain professional secrecy, but in case of
HIV+ve patients, he can reveal the HIV+ve status to the prospective
bride.
In case of married couple, the status of married partner can be told to
the spouse. The latter can then apply for divorce under provisions of
the Hindu Marriage Act, 1955.
Careful screening of blood
For HIV status - before blood donation, transfusion, surgical operation
or organ transplantation.
Precautions
(a) Screen living donors for HIV as close to the time of organ recovery
and transplantation as possible, using sensitive tests for both chronic
and acute infections, namely, serology and nucleic acid testing
[NAT]
(b) Inform transplant candidates of the potential risks for disease
transmission
(c) Advise donors that they have an obligation to avoid behaviors that
would put them at risk for acquiring HIV before organ donation.
Arguments in favor of routine screening
(a) Charges of negligence – may be brought by the patient, if patient
discovers after the operation that he is HIV +ve. He may allege that
the infection was transmitted through these procedures.
(b) Preoperative or pretransfusion screening will protect the doctor from
such charges
Arguments against routine screening
(a) The accepted ethical standards of autonomy, confidentiality, and
informed consent are broken.
E. Miscellaneous
Multiple tattooing with same needle may cause HIV transmission.
S. 269, I.P.C.: Negligent act likely to spread infection of disease
dangerous to life (imprisonment up to six months)
S. 270, I.P.C.: Malignant act likely to spread infection of disease
dangerous to life (imprisonment up to two years).
CONSUMER PROTECTION ACT,1986
[Amendment in 1991, 1993, 2002]
Consumer Protection Act (CPA) was enacted by Parliament in 1986 to
provide better protection of the interests of consumers in the
background of guidelines contained in the Consumer Protection
Resolution passed by U.N. General Assembly on 9th April 1985.
Aims and objectives
To protect the interest of consumers - of different commodities [eg
TV, car] and services [e.g. banking, airline travel etc.]
Protection of consumer from hazards to their health and safety.
Availability of effective consumer redressal forum.
Cheap and speedy remedy.
 The National Commission in 1993, in a ruling, includes medical
services under the provisions of Consumer Protection Act (CPA).
 In 1995, the Supreme Court of India (IMA vs V.P. Shantha) includes
medical services under the ambit of CPA.
The Apex Court arrived at the following conclusions
Service rendered to patient by 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
medical and surgical would fall within the ambit of service as defined in
section 2(1)(0) of the act.
Structure and Functioning of Consumer Redressal Agencies
Under CPA, the consumer dispute redressal agencies have been set up at
three levels to provide speedy and inexpensive judicial remedies to the
consumers.
District Consumer Disputes Redressal Forum District level
State Consumer Disputes Redressal Commission State level
National Consumer Disputes Redressal Commission National level
District Forum/Commission
Composition
District forum has three members.
One chairman – a sitting or retired Sessions and District Judge
Others two members are eminent citizens and amongst them one should be
female.
The age of the members should not be less than 35 years and they should
possess at least some bachelor’s degree.
The appointments are made by State government for a period of 5 years or
up to age of 65 years whichever is earlier.
Jurisdiction
Original jurisdiction
Entertain complains that does not exceed Rs. 20 lakhs
State Forum/Commission
Composition
State Commission has three members.
Presided by sitting or retired High Court Judge
Other two members are eminent citizens and amongst them one should be female.
Jurisdiction
Original jurisdiction
Appellate jurisdiction
Revision jurisdiction
Entertain complains that does not exceed 1 crore but over 20 lakhs
National Forum/Commission
Composition
It is located at New Delhi and consists of 5 members.
Presided by sitting or retired Supreme Court Judge
Other four members are eminent citizens and amongst them one
should be female.
Jurisdiction
Original jurisdiction
Appellate jurisdiction
Revision jurisdiction
Entertain complains that exceed Rs. 1 crore.
Manner of making complaints
A complaint in relation to any goods sold or delivered or any service provided
may be filed with a District Forum by
(a) The consumer. If consumer dies, his legal hair or representative
(b) Any recognized consumer association
(c) One or more consumers, where there are numerous consumers having the
same interest, with the permission of the District Forum
(d) Central or the State Government.
Every complaint must be accompanied by a fees prescribed by the State Govt
[S.12].
On receipt of a complaint
The District Forum may allow the complaint to be proceeded with or
rejected [after giving an opportunity to the complainant of being
heard].
Admissibility of the complaint shall ordinarily be decided within 21
days from the date on which the complaint was received [S.12(3)].
Frivolous or vexatious complaints – are dismissed after recording
the reasons in writing. The complainant may be asked to pay a cost of
up to 10,000 to the opposite party [S.26].
Procedure Trials
(1) Speedy trials
Every complaint is heard as early as possible and must preferably be
decided within 3 months.
No adjournment are ordinarily granted by DF unless sufficient cause is
shown and the reasons for grant of adjournment have been recorded in
writing by the Forum [S.13(3A)].
(2) If complaint refers to any service, the Forum shall refer a copy of such
complaint to the opposite party directing him to give his version of the case
within a period of 30 days. An extension of 15 days may be granted . Notices
may be served even by FAX [S.28(2)].
(3) It is not necessary for parties to be represented by lawyers.
(4) Every proceeding before the DF shall be deemed to be a judicial
proceeding within the meaning of S.193 and 228 of IPC, and DF shall
be deemed to be a civil court.
(5) Appeals against orders of District Forum
Must be made to the State Commission within 30 days from the date
of order.
If there was sufficient cause for appeal later than 30 days, State
Commission can entertain it.
Fees - appellant must deposit 50% of amount ordered by DF or
`25,000 whichever is less [S.15]
(6) Appeals against orders of State Commission
Must be made to the National Commission within 30 days from the
date of order.
If there was sufficient cause for appeal later than 30 days, National
Commission can entertain it.
Fees - appellant must deposit 50% of amount ordered by SC or 35,000
whichever is less [S.19].
(7) Appeals against orders of National Commission
National Commission is empowered to review its orders to avoid rush to the
Supreme Court
However even if review does not give relief to a party, the appeal must be
made to the Supreme Court within 30 days from the date of order.
If there was sufficient cause for appeal later than 30 days, Supreme Court
can entertain it
Fees - appellant must deposit 50% of amount ordered by SC or $ 50,000
whichever is less [S.23].
(8) Ensuring payment of compensation
To ensure payment of compensation, the Consumer Courts [DF, SC,
NC] can attach the property of the opposite party and dispose it to
recover amount due to the complainant.
District Collector would help the courts to recover this amount.
(9) Finality of orders
If no appeal has been preferred against order of a DF, SC or NC, such
order shall be final [S.24].
Limitation period
The District Forum, the State Commission or the National
Commission normally will not admit a complaint unless it is filed
within 2 years from the date on which negligence was committed.
But under special circumstances complaints after 2 years may be
entertained if the Forum or Commission is satisfied that there is
sufficient reason for doing so, and it must record in writing, the
reasons for entertaining such late complaints [S.24A].
Who is covered under COPRA
All doctors and hospitals who have charged for their service.
All doctors and hospitals [including Govt hospitals, health centers,
dispensaries etc] who perform partial charitable services, i.e. who
charge from few patients only [rich] and other [poor] are not charged.
All [both rich and poor] can get benefit under COPRA.
Who is immune from COPRA
Doctors and hospitals [including Govt hospitals] which are doing a
completely charitable service not charging anyone [i.e. neither rich
nor poor are charged].
Hospitals charging a token amount for registration purpose only – It is
not payment for the purposes of COPRA.
THE WORKMEN’S COMPENSATION ACT, 1923
The Workmen’s Compensation Act, 1923 [WCA, 1923] is one of the
earliest labor welfare and social security legislation enacted in India.
This Act provides for the payment of compensation to workmen for
injuries sustained by them in an accident, arising out of and in the
course of employment.
Aims and objectives
Provides compensation to workmen and their dependents - in case of
accidents arising out of and in the course of employment causing death
or disablement of workmen.
The amount of compensation depends upon whether the injury has
caused death, permanent total disablement or permanent partial
disablement.
The employer will not be liable to pay compensation in respect of any
injury which results in death or permanent total disablement caused by
an accident, if the workman at the time of sustaining injury was under
the influence of drink or drugs or willfully disregarded or removed any
safety guard or other device provided for his safety.
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Medical jurisprudence

  • 3. INTRODUCTION MEDICAL PRACTITIONER means an individual who practices the art of allopathic system of modern medicine. REGISTERED MEDICAL PRACTITIONER (RMP) means Medical Practitioner whose name appears in the official register kept for the purpose in accordance with the law of the land to which one belongs.
  • 4. The medical profession is governed by legislation(Law of the land) and by a Code of Ethics and Etiquette. The broad principles of medical ethics are formulated by National and State Medical Councils and the World Medical Association. The ethics are nothing but the moral principles that guide the members of medical profession.
  • 5. Thus the practice of medicine includes ethical practice within the legal framework of the State (Country). The enforcement is done by the Medical Council of India(MCI) and State Medical Council(SMC).
  • 6. INDIAN MEDICAL DEGREES ACT 1916 The Act was passed to grant the title in respect of the qualification of western medical science. According to the Act, we have right to grant medical degrees, diplomas and certificates to practice the western medical science but false use of a title is punishable under the Act.
  • 7. Medical Council of India In the year 1933, the Indian Legislative Assembly passed an Act known as the Indian Medical Council Act 1933. Now this Act stands repealed and in its place, the Indian Medical Council Act 1956 is enacted with following particulars.  To give recognition for representation of the licentiate medical practitioners.  To provide registration of foreign medical qualifications.
  • 8.  To provide for formation of a committee to help in reorganizing postgraduate medical education in the country.  To maintain an “All India Medical Register” containing names of Registered Medical Practitioner all over India.
  • 9. Composition of Medical Council of India Section 3 of the Act states that the medical Council of India (MCI) shall consist of: 1. One member from each State, other than Union territory to be nominated by the Central Government in consultation with the State government concerned. 2. One member from each University to be elected from amongst the members of medical faculty of the University by members of the senate of the University or members of the court if there is no senate.
  • 10. 3. One member from each state, in which a state medical register is maintained, to be elected from amongst themselves by persons enrolled on such register. 4. Seven members to be elected from amongst themselves by persons enrolled on any of the state medical register. 5. Eight members to be nominated by the Central government.
  • 11. The President and the Vice-President of the Council shall be elected by the members of the council from amongst themselves. The President and the Vice-President shall hold office for a term not exceeding five years and not exceeding beyond the expiry of term as a member of the council. The members of the council shall hold office for five years. The council appoints a Registrar who acts as a Secretary for day to day work of the council. Dr B C Roy was the first Indian to be President of MCI in 1939.
  • 12. The MCI carries out the purpose of Indian Medical council Act through an Executive Committee and through such other committees, as the council may deem necessary. These committees are constituted from amongst the members of the council.
  • 13. Functions of MCI Maintenance of Indian Medical Register The Council maintains a register of medical practitioners, known as the Indian Medical Register. It contains the names of all persons who are enrolled on any State Medical Register. If the name of a person enrolled on a State Medical Register is removed from the Register, the Council also removes such person's name from the Indian Medical Register.
  • 14. Regulation of standard of undergraduate and postgraduate medical education It maintains the uniform standard throughout the country in respect to Undergraduate and Post Graduate courses. There is a Post Graduate Medical Education Committee consisting of nine members to maintain a uniform standard in respect to Post Graduate Qualification imparted by different Universities. They also advice the Universities and give guidance in this respect.
  • 15. Prior approval of M.C.I. is required for starting a PG course in any discipline. If not followed the M.C.I. has power to derecognized the said qualifications. As regards to Under Graduate Medical Education, the Council prescribes minimum standard. It appoints Medical Inspectors to inspect the various colleges before giving sanction either to start a new college or to renew it.
  • 16. Even to increase the numbers of seats in Medical College requires M.C.I.’s prior permission. The inspectors submit the report to the M.C.I. which is considered by the committee formed. Then the committee recommends to the Government to grant permission or not. In cases when the Council is not satisfied, it recommends the Government to withdraw the recognition.
  • 17. Recognition of Medical Qualification The MCI recognizes medical qualification granted by universities/institutions and maintains three schedules for recognition of medical qualification. The schedules are as follows. 1. As per First schedule of the Act, medical qualifications granted by recognized universities in India are recognized by council. 2. As per Second schedule, the medical qualifications granted by institutions outside India are recognized by council.
  • 18. 3. Third schedule has two parts As per part I of third schedule, the medical qualification granted by institution of India but not included in first schedule. Part II of third schedule recognizes those medical qualifications granted by institutions outside India but not included in second schedule.
  • 19. Recognition of foreign medical qualifications Indian National with foreign degree which is not included in the part II of the third schedule applied to central government along with the full information in respect of the syllabus and duration of course etc. The Central Government forwards the applications to Indian Medical Council which has authority to enter in negotiations with any of the Medical Council of the Foreign Countries and can recognize such Qualifications. Then the Central Government by official gazette notification may amend the part II and includes such qualifications.
  • 20. Appeal against Disciplinary Action When name of any doctor is removed from the state medical register, he may appeal to Central Government after exhaustion of all the official remedies under the state medical council. He should apply within 30 days from the date of decisions along with all the relevant documents. The Central Government will consult MCI and MCI then examines the facts under inquiry and furnish its recommendations to Central Government. The recommendations made by MCI are binding on the State Government and the State Medical Council
  • 21. Disciplinary Control The MCI prescribes minimum standards for Registered Medical Practitioner with reference to professional conduct, ethics and etiquette. The MCI exercises disciplinary control over RMP. The MCI can issue warning notices to its members for involvement in unethical practices falling under the meaning of the term ‘infamous conduct in a professional sense’.
  • 22. Certificates It is empowered to issue certificates of good conduct and character to medical students/doctors going abroad for higher studies/service. CME programmes It sponsors and organizes continuing medical education (CME) programmes for medical practitioners.
  • 23. Faculty development programme MCI has undertaken the task of training the medical college faculty upto the level of Associate Professorsin MCI Basic Workshop in Medical Education Technologies. Faculty should undergo this training either before joining service or during probation period and once every 5 years thereafter.
  • 24. State Medical Council (SMC) The State Medical Councils are autonomous bodies, established under the State Medical Council Act. Each of these Medical Councils consists of members elected by the registered medical practitioners and those nominated by the State Government. The President and the Vice-President of the Council are elected by the members from among themselves.
  • 25. Functions of SMC Maintenance of Medical Register The Council appoints a Registrar, who keeps a Register of medical practitioners. On payment of prescribed fees, the name, address and qualifications are entered in the register. A provisional registration is granted to a student who has passed the qualifying examination, but has to undergo a certain period of training (internship for 1 year) in an approved institution, and permanent registration is granted after that training period.
  • 26. Additional qualification obtained subsequent to registration or for any alteration may be done after payment of requisite fees to the SMC. The Registrar should inform the Indian Medical Council without delay, of all additions and other amendments in the State Medical Register, made from time to time.
  • 27. Disciplinary control The Council is entrusted with disciplinary control over the registered medical practitioner. SMC can issue warning, suspension or penal erasure of the name of medical practitioner found indulging in unethical practice, and advises them to conduct themselves according to the ethical norms prescribed by the Council. It can act against doctors for professional negligence too. The SMC takes cognizance of any misconduct (professional) in case:  Convicted by court for any criminal offence.  A complaint has been lodged against him by some person or body.
  • 28. Disciplinary functions of State Medical Council
  • 29. Erasure of Name The name of the doctor is removed from the Medical Register: (1) After the death of the registered practitioner. (2) Entries which are made in error or as a result of fraud. (3) Penal erasure
  • 30. Penal Erasure refers to removal of a medical practitioners name from the medical register temporarily or permanently as a penalty. Done when doctor is guilty of serious professional misconduct(infamous conduct). Doctor can not practice medicine till his name remains removed from register. If the name removed permanently, doctor can not practice for life. This is known as PROFESSIONAL DEATH SENTENCE.
  • 32. Ethical aspects of medical practice Medical Ethics The word “ethics” is derived from “ethikos” which means manner and habit of man. Medical ethics deals with the moral principles, values and guidelines that govern the conduct and relationship of doctor with his patients. DOCTOR PATIENTS
  • 33. In other words, medical ethics are the code of behaviour accepted voluntarily within the profession. Medical etiquette Refers to the conventional laws of courtesy observed between members of the medical profession. DOCTOR DOCTOR Violation of medical etiquette is NOT punishable under law
  • 34. A registered medical practitioner is required to observe certain prescribed rules of conduct contained in Code of Medical Ethics, published by the Medical Council of India and by many State Medical Councils. Known as.. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (amended in 2009, 2016).
  • 35. These regulations are binding on all doctors registered with the Medical Council of India/State Medical Council. The regulations prescribed by the MCI contain eight chapters. Chapter 1: Code of medical ethics. Chapter 2: Duties of Physician to their patients. Chapter 3: Duties of Physician in consultation. Chapter 4: Responsibilities of physician to each other.
  • 36. Chapter 5: Duties of Physician to the public and to the paramedical profession Chapter 6: Unethical acts Chapter 7: Misconduct Chapter 8: Punishment and disciplinary action
  • 37. Code of Medical Ethics At the time of registration, all the doctors are self-warned about certain unethical practices (infamous conduct) and the disciplinary action by the SMC (also called as warning notice). The applicant should certify that he/she had read and agreed to abide by the declaration and submit a declaration duly signed.
  • 38. Declaration of Geneva (Physician’s Oath; modernized version of Hippocratic Oath) It was amended at Sydney in 1968. I will solemnly pledge myself to consecrate my life to the service of humanity. I will give to my teachers the respect and gratitude which is their due. I will practice my profession with conscience and dignity. The health of my patient will be my first consideration.
  • 39. I will respect the secrets which are confided in me, even after the patient has died. I will maintain by all means in my power the honour and the noble traditions of the medical profession. My colleagues will be my brothers. I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
  • 40. I will maintain the utmost respect for human life from the time of conception; even under threat. I will not use my medical knowledge contrary to the laws of humanity. I make these promises solemnly, freely and upon my honour.
  • 41. Rights of a Registered Medical Practitioner The rights are (1) Right to choose his patient (EXCEPT IN EMERGENCY). (2) Right to add titles, qualifications etc after his name. (3) Right to practice and dispense medicines. (4) Right to possess and supply dangerous drugs to his patients. (5) Right to recovery of fees. (6) Right to give evidence as an expert. (7) Right to issue medical certificates. (8) Right for appointment to public and local hospitals.
  • 42. Duties of a Medical Practitioner 1. General duties and responsibilities Dignity - Doctor should uphold the dignity and honor of his profession. Modesty - Should be modest, sober, pleasing in personality, should have patience. Should be eager to help patients. Knowledge - Should keep abreast of advances of medical science, and improve his knowledge and skills by referring to latest books, journals, attending conferences.
  • 43. 2. Duties of medical practitioners to their patients in particular a. Duty to exercise a reasonable degree of skill and knowledge b. Legal duty to render service Doctor can withdraw treatment under following conditions (i) Treatment is no longer required (ii) Patient asks him to withdraw treatment (iii) Mutual assent of both parties (iv) After giving notice with a reasonable time for patient to find another doctor (v) Physician himself becomes sick (vi) Patient is found to be malingering
  • 44. (vii) patient is using remedies other than those prescribed by him; (viii) patient ignoring his instructions; (ix) patient seeing another doctor without informing him; (x) patient is using contraband drugs, intoxicants or poisons; (xi) patient not fulfilling his earlier financial obligations [not paying fees] c. Prognosis Doctor should neither exaggerate, nor minimize the gravity of his patient’s condition
  • 45. d. Patient must not be neglected e. Engagement for an obstetric case If a doctor A who was engaged to attend to an obstetric case is absent, and another doctor B is sent to conduct delivery, B is entitled for his professional fees. When A returns, B should leave the patient only after securing the patient’s consent. f. Duty in emergency g. Duty to give instructions h. Duty to inform and warn i. Clearly display his fees and other charges on the board of his chamber and the hospitals he is visiting.
  • 46. j. Professional secrecy (confidentiality) Professional secrecy refers to the doctor’s obligation to keep secret all information regarding patient that he comes to know in the course of his professional work. It is an implied term of contract between doctor and patient. Information can be divulged - with patient’s consent. Situations when doctor should not reveal condition of patient (i) Press conferences (ii) Information to parents Doctor can communicate illness of a minor or mentally ill person to the legal guardians. (iii) Information to third parties (Except privileged communication)
  • 47. (iv) Husband and wife – Condition of one can not be told to the other. (v) When free treatment is provided – Doctor still has to maintain professional secrecy (vi) Information regarding dead person (vii) Reporting in a medical journal – may be revealed to readers, but identity of patient must be hidden (viii) Postmortem findings – should be revealed only to the police.
  • 48. (5) Punishment for not maintaining professional secrecy (i) u/s 499, IPC – defamation. Punishment for defamation is 2 years (u/s 500, IPC) (ii) Civil action for damages (iii) He can complain to MCI/SMC, which can take disciplinary action. k. Privileged communication There occur some situations where the doctor has to divulge the patient’s details to certain authorities. This divulgence of the details is known as privileged communication and is an exception to professional secrecy.
  • 49. Situations where privileged communication holds true are.. In Society’s interest In patient’s interest In a third party’s interest In doctor’s own interest Court of law Notifiable diseases Suspected crime Employers Medical for insurance Waiver of professional secrecy
  • 50. 3. Duties of RMP Towards Professional Colleague Not to criticize colleague Never take fees, should consider it a pleasure and privilege to render gratuitous service to all fellow doctors and their family dependents. Always help Duties with regard to consultation.  Ask for consultation only when it is required.  Patient’s consent-talk about the same with the patient or his relatives and inform about the reasons for the same.  If they object, mention in the case records.
  • 51. 4. Duties of medical practitioners to the public in general and to the paramedical profession Duty to notify certain diseases Duties to inform vital events Should disseminate advice on public health issues. Should co-operate with the authorities in the administration of sanitary and public health laws and regulations.
  • 52. 5. Duties of medical practitioner in criminal matters Section 39 of CrPC, RMP should communicate to the police any information about a criminal act that has come to his knowledge. Attempt to commit suicide (section 309 of IPC) is not included in section 39 of CrPC. It is therefore not mandatory for RMP, doing private practice, to supply such information of his own accord to police or magistrate. However, he is duty bound to inform police if the person happens to die.
  • 53. section of 175 of CrPC, the doctor has to provide all the information if asked by police or magistrate. Failure to provide or concealing of such information is punishable under section 202 of IPC. Also charged under section 201 of IPC for destruction of evidences and/or if doctor fails to discharge his duties to inform police in time. Preservation of trace evidences and samples (e.g. gastric lavage, blood etc.), clothes, foreign bodies such as weapon, bullet/pellets etc. in an injured or poisoning patient or sexual offenses cases should be done by doctor and handed over to the police/investigating officer. Preservation of record: The indoor patient’s record should be made and preserved.
  • 54. PROFESSIONAL MISCONDUCT (INFAMOUS CONDUCT) Professional misconduct (syn. Infamous conduct, ethical misconduct, ethical negligence, ethical malpraxis) is that act of a medical man which would be reasonably regarded as disgraceful or dishonorable by his professional brethren of good repute and competence. Professional misconduct should include only those actions for which there are no punishments in IPC or in any other existing civil or criminal law, yet MCI or SMC can take action.
  • 55. List of Professional Misconducts (1) Adultery or improper conduct or association with a patient. (2) Conviction by court of law of offences involving moral turpitude. (3) Issuance of false certificates, reports and other documents. (4) Association with unqualified persons. (5) Contraventions of drug acts and regulations. (6) Selling a scheduled poison to the public. (7) Performing an illegal abortion or enabling an unqualified person to perform an abortion. (8) Issuance of certificate of efficiency in modern medicine to unqualified or non-medical persons.
  • 56. (9) Contributing articles to the lay press and giving interviews regarding diseases and treatments which may have the effect of advertising himself or soliciting practice. (10) Using an unusually large signboard. It is also improper to affix a signboard on a chemist’s shop or in places where he does not reside or work. (11) Disclosing the secrets of his patients to others, except when bound by law.
  • 57. (12) Refusing treatment on religious grounds. (13) Publishing photographs of his patient in any medical journal (by which his identity could be made out) without obtaining the consent of that patient. (14) Publicly displaying his fees, except in his consulting room. (15) Using touts or agents to procure patients.
  • 58. (16) Receiving or giving commission or other benefits from fellow doctors, traders, chemists, manufacturers etc. Giving of commission by one doctor to another for favor of recommending or referring the patient to him is known as dichotomy or fee-sharing or fee-splitting. (17) Talking disparagingly about other colleagues or doing anything that means unfair competition. (18) Not attending a patient when he is already under his treatment. (19) Addiction to narcotic drugs.
  • 59. (20) Alcoholism. (21) Using unsterile instruments, or not furnishing his patients with proper information about drugs or diet. (22) Covering i.e. assisting someone who has no medical qualification to attend, treat or perform an operation on some person in cases requiring profession skill. (23) Running an open shop for the sale of medicines. (24) Writing prescriptions in a secret formula known to some particular pharmacy only. (25) Commercialization of a secret remedy. (26) Accepting any gift or travel facilities etc from pharmaceutical companies.
  • 60. The 6 A’s of Serious Professional Misconduct (1) Association with unqualified persons – e.g. employment of touts to procure patients. (2) Advertising – It is improper to use an unusually large sign board to advertise oneself. (3) Adultery–arising out of professional relationship. (4) Abortion (unlawful) – Unlawful abortion includes prenatal determination of sex and then inducing abortion. (5) Addiction – Addiction to drugs or doctor supplying drugs of addiction to addicts. (6) Alcohol – Seeing patients under the influence of alcohol.
  • 61.
  • 62. RIGHTS AND DUTIES OF PATIENTS Rights and Privileges of Patients 1. Right to choose doctor 2. Right to access health care facilities available regardless of age, sex, caste, religion, and economic or social status. 3. Right to be treated with dignity, with care, respect and without any discrimination 4. Right to have privacy during consultation or treatment 5. Right to have confidentiality of all his information furnished to doctor 6. Right to receive full information about the diagnosis, investigations and available methods of treatment.
  • 63. 7. Right to know the procedure of operation, risk involved therein, available alternatives, the type of procedure, and the safety of procedure, results and prognosis. 8. Right to seek second opinion from another doctor 9. Right to demand for the medical record 10. Right to complain and rectification of grievances 11. Right to obtain compensation for medical injuries or negligence.
  • 64. Duties of Patients 1. Duty of patient to furnish all information related with health to doctor 2. Duty of patient to follow the instructions/advice given by doctor 3. Duty to pay fees to the doctor 4. If the patient wishes to take second consultation or second opinion, the patient should inform the first doctor 5. The patient should have faith in the doctor chosen for treatment 6. The patient should not contribute to medical negligence 7. The patient should co-operate with the Medical Practitioner for the necessary laboratory investigations such as X-rays, ECG etc. because these tests may be necessary for the diagnosis and proper treatment.
  • 65. Infringement by doctors of patient’s rights a. Paternalism Paternalism [Gk. pater, father] is acting upon one’s own idea of what is best for another person without consulting that other person. PATERNALISM PATIENT AUTONOMY Up to 19th century, paternalism was prevalent and legal. It is no more legal. Paternalism (in a conscious, mentally sound, adult patient), although done in the patient’s best interests, is illegal. The doctor may be sued u/s 350, IPC [using criminal force].
  • 66. b. Therapeutic privilege Therapeutic privilege [TP] is the doctor’s privilege not to reveal to the patient that part of the information about his illness, which he genuinely thinks would lower patient’s morale and his will to live. In order to save himself from later litigation doctor should Obtain expert consultation that patient is really emotionally disturbed and divulging information may cause more harm. Report of that consultation must be attached to the case sheet Record in patient’s case sheet what he not disclosing and why As far as possible, information should be told to patient’s spouse or next of kin.
  • 67. Abuse by patients of their rights Malingering Malingering or shamming is conscious planning, feigning and pretending a disease for the sake of some advantage. Malingering is done by people to have following advantages: by workmen to claim compensation. by policemen or military people to prevent hard postings. by prisoners to avoid hard labor, or capital punishment. by govt. servants to prevent transfers. by businessmen to avoid contracts. by beggars to attract public sympathy.
  • 68. M/L Importance (i) If the patient gets a medical certificate by narrating false symptoms, and uses it for any purpose, he may be sued u/s 198, IPC [punishment 7 y+fine] (ii) Cheating – May be sued u/s 415, IPC [cheating].Punishment 1 y or fine or both [S.417, IPC] (iii)Must be differentiated from perjury. Malingering is not perjury, as patient does not speak a lie under oath.
  • 70. PROFESSIONAL NEGLIGENCE Professional negligence, medical negligence or malpraxis is absence of reasonable care and skill, or willful negligence of a medical practitioner in the treatment of a patient, which causes injury or death of the patient. Alternative definition - doing something that one is not supposed to do [act of commission] and failing to do something that one is supposed to do [act of omission].
  • 71. Reasonable care also called “due care” (a)Includes such reasonable care and attention that the patient may require. (b)Must anticipate and appropriately manage known, expected or foreseeable events and complications of patient’s disease and treatment (c) It should be proportionate with (i) Qualification of doctor (ii) Known inability of the patient to take care of himself – unconscious patient requires higher level of care and attention than a conscious patient.
  • 72. Reasonable care is breached in 2 situations (a) When doctor unjustifiably deviates from accepted methods, practices, procedures and treatments. (b) When he used accepted methods but does so unskillfully. Free service - Doctor provided free medical service " injury or death of patient occurred " doctor still liable to be prosecuted under criminal law, but cannot be made to pay compensation.
  • 73. Components of medical negligence For a case of medical negligence to be established, the following components must be present (4Ds). 1. Duty-The doctor begins to owe a duty towards a patient As soon as he agrees to treat him. When he is in emergency. A doctor-patient relationship is established at that point in time. Doctor-patient relationship is not formed when patient is not in emergency and the doctor did not agree to treat the patient.
  • 74. 2. Dereliction of duty Once the presence of duty has been established, there has to be a dereliction of duty on the part of the doctor, i.e. the doctor should have been negligent in performing his duties towards the patient.
  • 75. 3. Damage The damage must occur as a result of dereliction, and it must be foreseeable. Even if doctor is negligent, patient cannot sue him for compensation, if no damage has occurred. He can however be sued criminally u/s 336, IPC. Some examples of possible damages are  Aggravation - of a preexisting condition  Diminishing patient’s chances of recovery  Expenses incurred  Pain and suffering – causing either physical or mental [embarrassment, fright, humiliation] pain or increasing it  Loss of earning
  • 76.  Loss of potency  Prolonging his illness  Reduced enjoyment of life – eg loss of a limb or sense  Reduction in expectation of life  Death
  • 77. 4. Direct causation Damage must result directly from dereliction [proximate cause], and not from any other cause. Proximate cause refers to a cause, which in natural and continuous sequence, unbroken by any efficient intervening cause, produces the injury, and without which the injury would not have occurred.
  • 78. Types of Negligence 1. Medical negligence a. Civil negligence b. Criminal negligence 2. Patient negligence 3. Contributory negligence 4. Composite negligence 5. Corporate negligence
  • 79. a. Civil negligence (Civil Malpraxis) Civil negligence is said to occur when patient demands monetary compensation for the damage that he has suffered due to the doctor’s negligence. Civil negligence comes under tort law. Salient features of Civil negligence 1. Question of civil negligence also arises - When patient refuses to pay doctor’s fees alleging negligence, and doctor brings a civil suit against patient to recover his fees.
  • 80. 2. Court - The case goes either to civil court or to consumer forum 3. Punishment - The doctor only has to pay whatever compensation the court decides. There is no criminal liability for him and he cannot be sent to jail for his action. 4. Additional punishments - However if the patient complains to medical council also, it can take action against the doctor and can punish him accordingly.
  • 81. 5. Standard of proof – It is the duty of the patient to prove negligence. 6. Defenses (i) Informed consent (ii) Contributory negligence b. Criminal negligence (Criminal Malpraxis) Criminal negligence is that when patient complains to the police regarding the misconduct of the doctor, and the police registers a case against the doctor.
  • 82. Salient features of Criminal negligence 1. Who fights the case - State i.e. the government fights the case against the erring doctor. 2. Punishment - The doctor is prosecuted under the various sections of the Indian Penal Code (IPC) and if found guilty the doctor is liable to pay damages as well as can be sentenced to a term in the prison. 3. Standard of proof - In criminal negligence - in contrast to civil negligence the burden of proof that is required to prove the guilt is “beyond reasonable doubt”. There should be >99% probability of the doctor being guilty.
  • 83. Classification of Criminal negligence (1) When no injury to the patient occurs (S.336, IPC) Negligent action but no injury " Patient cannot claim compensation, but he can still lodge a criminal complaint against him under S.336, IPC. If the doctor’s conduct was so rash or negligent as to endanger patient’s life or his personal safety. Punishment is imprisonment of 3 months, or `250 fine, or both.
  • 84. (2) When injury occurs to the patient When hurt is caused to the patient (S.337, IPC) Negligent action Patient suffers hurt. Punishment is imprisonment of 6 months, or `500 fine, or both. When grievous hurt is caused to the patient (S.338, IPC) Negligent action Patient suffers grievous hurt Punishment is imprisonment of 2 years, or `1000 fine, or both.
  • 85. When death is caused (S.304A, IPC) Negligent action Death of patient . The punishment is imprisonment of 2 years, or fine (any amount) or both. 2. Patient negligence Patient negligence is outright negligence by patient only. Doctor is not negligent.
  • 86. Salient features Doctor is not liable in such cases. Examples (i) Patient does not give correct history (ii) Starts an alternative form of treatment without informing doctor (iii) Does not follow doctor’s instructions. (iv) Discontinues treatment (v) Refuses to take treatment (vi) LAMA – leaving [hospital] against Medical advice.
  • 87. 3. Contributory negligence Contributory negligence is the name given to a situation, where both doctor and the patient are negligent. Examples Doctor applies tight plaster cast on patient’s leg [doctor negligent], but instructs him to report numbness " Patient develops numbness in his toes " does not inform doctor [patient negligent] " suffers permanent injury " Doctor entitled to the defense of contributory negligence.
  • 88. Doctor prescribes drug " fails to inform the patient of its side effects [doctor negligent] " patient starts getting side effects " fails to inform the doctor [patient negligent] " suffers injury “ contributory negligence. Burden of proof – lies with the doctor
  • 89. Doctrine of comparative [or proportionate] negligence - Quantum of injury caused by patient’s and doctor’s negligence is decided by the court and the compensation awarded accordingly. If, say, patient’s negligence is responsible for 80% of his injury, and doctor’s negligence for 20%, patient would be entitled only to 20% of the compensation. Contributory negligence is a good defense in civil cases, but cannot be taken as a defense in criminal cases.
  • 90. Exceptions of contributory negligence Last clear chance doctrine Both doctor and patient are negligent. But if it is shown that the defendant (doctor) had a “Last Clear Chance” to avert the damage caused to the patient, and he did not avail of this chance, he loses his defense of contributory negligence.
  • 91. Example Doctor prescribes drug to patient " fails to inform of side-effects [doctor negligent] " Patient develops rashes, but fails to inform doctor [patient also negligent, so concept of contributory negligence comes into play] " Patient visits doctor on the next date " doctor sees rashes " fails to take remedial action " Patient suffers injury " sues doctor " Doctor takes plea of contributory negligence.
  • 92. Analysis Patient can allege that the doctor had the “last clear chance” to avoid injury, because on the patient’s next visit, the doctor did see his rashes and yet did not do anything.
  • 93. The Avoidable Consequences Rule Both parties are negligent, but patient could have avoided his own injuries by being more careful [It is in fact a variation of the Last clear chance doctrine” in as much as he himself had the “last chance” to avoid injuries]. He could have avoided the consequences of doctor’s negligence, but he did not carefully act upon it. So he himself is responsible for his injuries and doctor need not to pay.
  • 94. Example Doctor does not apply bandage and antibiotics to a gaping lacerated wound (doctor negligent) " He however advises the patient not to allow the wound to get contaminated, and visit him next week to get his wound examined again “. Patient comes home and thinks that applying cow dung would heal his wound faster " applies cow dung on his wounds " develops pus, but he does not contact the doctor. Nor does he visit the doctor next week, as was advised by the doctor (patient negligent) " Patient suffers injury.
  • 95. Analysis Here both doctor and patient are negligent and normally the compensation should have been shared between the doctor and the patient. But since the patient aggravated his own injury by doing something which was avoidable, the doctor would be covered under the “avoidable consequences rule” and he does not have to pay anything.
  • 96. 4. Composite negligence Composite negligence is said to occur, when a patient suffers injury as a result of the combined negligence of two or more doctors. 5. Corporate negligence Corporate negligence is the negligence of a corporation [hospital]. The individual doctor may or may not necessarily be liable in this case.
  • 97. Under the doctrine of corporate liability, a corporate house or hospital may have a duty to properly select the persons of professional competence. The hospitals may even be duty bound to intervene actively where a physician is negligent and prevent errant staff from endangering hospitalized patients. To prove a charge of corporate negligence, the plaintiff would have to show that the hospital was aware that the physician associated with the hospital was providing sub-standard care.
  • 99. Important Concepts Related to Medical Negligence Vicarious liability Vicarious liability[vicarious responsibility] means that a person is liable for the wrongful acts or omissions of another.
  • 100. Salient features Respondeat superior- [let the superior reply] Vicarious liability arises under the principle of respondeat superior. The employer is responsible not only for his own negligence but also for the negligence of his employees, if such acts occur in the course of the employment and within its scope.
  • 101. Also known as “captain of the ship” doctrine. RS becomes applicable when the superior had the “right, ability or duty to control” the activities of a violator. RS is the principle, while VL is the liability it puts on a superior. RS principle ensures that employers engage the best possible talent in their hospital.
  • 102. Preconditions There must be an employer – employee relationship Employee’s conduct must occur within the scope of his employment [i.e. employee did what he was legally supposed to do] It should occur while on the job. Compensation Both the negligent doctor as well as his employer may be asked to compensate patient by the court. Employer may engage in a separate “third party proceeding” to recover money from the negligent doctor.
  • 103. Relationships when one is vicariously responsible for the negligence of other Senior doctor - responsible for negligence of junior doctor, resident, intern or an assistant working under his supervision Hospital – responsible for negligence of its doctor Two or more doctors working in partnership –each is responsible for negligence of other Two or more doctors attending on a patient independently – each may be held liable for the negligence of other, if negligence produced symptoms and signs which an ordinary doctor should have noticed and objected to.
  • 104. Doctor referring his patient to an incompetent doctor knowingly Referring doctor is vicariously responsible for negligence of incompetent doctor. Doctor writing illegible prescription and pharmacist dispensing wrong drug – doctor is vicariously liable. Doctor instructing prescription over telephone and pharmacist dispensing wrong drug – doctor vicariously responsible When an employee has been temporarily borrowed from another
  • 105. Relationships when one is not vicariously responsible for the negligence of other Surgeon and anesthetist Qualified nurse acting independently, not under the direct supervision and control of doctor – doctor not vicariously responsible Doctor referring his patient to a competent doctor – referring doctor not responsible. Doctor referring an already injured patient due to his negligence to a new doctor or hospital – the latter is not vicariously responsible Doctor writing clear, legible prescription and pharmacist dispensing wrong drug – doctor not liable
  • 106. Borrowed servant doctrine Borrowed servant doctrine states that if an employee is temporarily borrowed by an employer from the principal employer, then the temporary new employer becomes vicariously liable for any negligent act done by the employee.
  • 107. Lending employer temporarily surrenders control over the employee. The new master gains control over the employee and directly supervises the employee and can give orders to him. The new master is responsible for the actions of hired employee [borrowed servant] only as long as he is under his direct supervision. After the employee is returned, the original employer becomes responsible for his negligent actions again.
  • 108. Example Resident [R] works on a regular basis in a private hospital [H]. An independent private specialist [S] hires an OT in H and also services of R " R commits an act of negligence when he had been hired by S " Although R is a regular employee of H, the latter is not vicariously responsible; S is vicariously responsible, because negligence occurred when R was in direct supervision of S.
  • 109. Res ipsa loquitur Ordinarily the professional negligence of a doctor must be proved by the patient. Res ipsa loquitur [the thing or fact speaks for itself] is an important exception to this rule, because here the professional negligence is so glaring and obvious that it speaks for itself.
  • 110. Conditions to be satisfied before this rule can be legally applied Injury to the patient would not have occurred in the absence of negligence. Doctor had exclusive control over the injury producing instrument or treatment. The patient was not guilty of contributory negligence.
  • 111. How proved Generally without expert medical evidence. Common knowledge or experience of a layman should be enough to understand and appreciate that the negligence must have caused the injury [“Doctrine of common knowledge” or “Common knowledge doctrine”]. Applicable To both civil and criminal negligence.
  • 112. Doctrine of common knowledge Doctrine of common knowledge” states that when negligence is of such obvious nature that even a layman with ordinary common knowledge having no technical expertise can appreciate it, then evidence of a medical expert to prove negligence is not required.
  • 113. Examples Antiseptic – Failure to apply to an open cut Anti tetanus serum – failure to give in cases of gross injuries. Patient developing tetanus. Artery forceps, swabs etc - left in the abdomen. Blood transfusions –mismatched Breaking of needles Burns from cauterizing tool at unintended places from application of hot water bottles for excessively long time from negligent application of X-ray therapy Fluids – failure to give in obvious dehydration Giving poisonous medicines recklessly Prescribing overdose of medicines Prolonged splinting; too tight a bandage or plaster – loss of use of a limb Wrong amputation – eg right leg [eye, kidney etc] has been amputated instead of the left Wrong teeth removed Wrong person -operated upon.
  • 114. Defenses Against Negligence 1. Actual denial The doctor denies his responsibility straightaway and that he discharged his duties according to the prevailing standards. His records should be proper and complete to prove this assertion.
  • 115. 2. Calculated risk doctrine Calculated risk doctrine [syn, doctrine of professional medical judgment] asserts that doctor is not liable if he took a reasonable and calculated risk to save life of patient and in the process patient suffered injury.
  • 116. Medical profession is a highly risk prone area and treatment often involves a calculated risk. If a physician chooses a course of treatment for a patient within a range of medically accepted choices, after a proper examination and evaluation, the calculated risk doctrine will insulate him from liability. To impose liability, a plaintiff must show that the doctor’s decision was something that fell below the certified medical determination.
  • 117. What doctor must prove He must produce expert evidence or statistics that the line of treatment he chose was a medically acceptable procedure under the conditions, and that it had unavoidable risks. Examples ADR to penicillin, streptomycin, IV antibiotics. Immunizations of all sorts, blood transfusions, X-ray dye studies. Injections into the spinal canal, injections of gold for rheumatoid arthritis, and injections of cortisone directly into the joint.
  • 118. 3. Contributory negligence 4. Emergency In emergency doctor may take some drastic measures to save life, which may cause injury e.g. fracture of ribs during cardiac massage. Falls under calculated risk doctrine also.
  • 119. 5. Law of limitation Law of limitation specifies that a claim for compensation can be brought against a doctor within a specified period. If the claim is brought after that period, the doctor can take the defense of limitation. The patient must file a complaint within a period of 2 years of discovery of alleged negligence.
  • 120. 6. Medical misadventure Medical misadventure [Medical maloccurrence] is defined as a bad or undesirable outcome that is unrelated to the quality of care provided. It is an unintentional and unforeseen accident, disaster or mischief, which occurs due to individual biological variations.
  • 121. 7. No duty owed towards the patient If the doctor had not agreed to treat patient, no duty exists. 8. Novus actus interveniens Novus actus interveniens [an unrelated act intervening] refers to a situation, where the doctor has been negligent, but a completely unexpected and unforeseen act happened which further worsened the patient’s condition.
  • 122. The new act intervening should be completely unexpected and unforeseen. Sometimes referred to as an “Act of God”. Breaks the chain of causation between the act of negligence and the resulting damage. Thus injury no more remains a proximate cause of doctor’s negligence. 9. Patient negligence
  • 123. 10. Res judicata Res judicata is a Latin term meaning “the thing has already been decided”. Also known as the “doctrine of double jeopardy”. If a question of negligence against a doctor has been decided in one court, the patient cannot start another proceeding in a different court. Appeal to the higher court however is allowed.
  • 124. 11. Volenti non fit injuria Volenti non fit injuria [, to a willing person, injury is not done] is a legal doctrine which means that if someone willingly places himself in a position where harm might result, he will not be able to bring a claim against the other party. For this claim to succeed the doctor must show that an informed consent had been taken and all side-effects had been explained,
  • 125. 12. Countersuits by doctors Doctor files a countersuit against the patient. Should only be resorted to when the doctor is absolutely sure there was no fault and the litigation is frivolous.
  • 127. CONSENT IN MEDICAL PRACTICE Consent is defined as free and voluntary agreement, compliance or permission given for a specified act or purpose. Indian Contract Act, 1872 (i) S.13 - Two or more persons are said to consent when they agree upon the same thing in the same sense. Patient must understand, what it is given for and what are the risks involved (ii) S.14 - Consent is said to be free and voluntary when it is not obtained by coercion, undue influence, fraud, misrepresentation, mistake and from mentally unsound person.
  • 128. Components of a legally valid consent Patient >12 y [for general physical examination]; >18 y [for surgery]. In case of child, consent from guardian who should be >18 y Patient understands that he can either agree or refuse to submit to examination, diagnosis and treatment. Has been provided full information on his disease and treatment options.
  • 129. Consent should be clear, direct, free, informed, intelligent, personal and voluntary (a) “Clear” in unambiguous words (b) “Direct” directly conveyed to the doctor by patient, with no intermediaries. (c) “Free” without undue force (d) Informed (e) “Intelligent” patient should have clearly understood the implications of treatment. No ambiguity. No communication barriers (f) “Personal” Doctor should not communicate to anyone, what the patient has consented for (g) “Voluntary” of his own accord.
  • 130. Consent of an arrested person at police request – not necessary u/s 53, CrPC. Consent of an arrested person at his own request u/s 54, CrPC, mandates compulsory medical inspection in all cases of arrest by the police. A copy of the medical report is to be provided to the arrested person or his nominee. If the arrested person is a female, her examination can be done only by or under the supervision of a female doctor.
  • 131. Consent of victim in criminal cases – In victims of assault, rape and in cases involving pregnancy, abortion and delivery, examination of victim is necessary to gather evidence of crime. However if victim does not consent to examination it cannot be done.
  • 132. Consent of spouse Legally required for (a) Receiving artificial insemination. (b) Donation of ovum or sperm. Legally not required but desirable to avoid marital conflict later (a) MTP (b) Sterilization (c) Any operation that can affect sexual life [breast reduction, penectomy, penis transplantation ]
  • 133. S.87, IPC - It is not meant for doctors, because the act done by perpetrator is not done for the benefit of the opposite party. (i) It is applicable to people who undertake risky activities. (ii) To participate in a risky activity, the consenting person must be >18 y. (iii)The act by the perpetrator must neither be intended, nor known to be likely to cause death or grievous hurt.
  • 134. S.88, IPC - It is meant for doctors, because the act done by perpetrator is done in good faith for the benefit of the opposite party. (i) It is applicable to doctors (ii) The consenting person must be >12 y [S.90, IPC].
  • 135. S.89, IPC - Act done in good faith for benefit of child <12 y or a person of unsound mind, by consent of guardian – is not punishable.
  • 136. What makes consent valueless – Consent given (i) Under fear of injury (ii) Under a misconception of fact (iii)Consent of mentally unsound person (iv) Consent under intoxication (v) Consent of child <12 y [S.90, IPC]
  • 137. S.52, IPC - Definition of “Good faith” — Nothing is said to be done or believed in “good faith” which is done or believed without due care and attention. Loco parentis [in place of parent] – In emergency if parents are not available, person in charge of child [e.g. a school teacher, a hostel warden] can give consent. Inmate of jail, hostel etc. refuses treatment, and he is likely to spread disease - he can be forcibly administered treatment. Inmate of a hostel may be asked to leave hostel.
  • 138. In state mandated national programs – e.g. pulse polio, vaccinations, no consent is needed. Consent for illegal acts [e.g. criminal abortion] – is invalid. Consent is not a defense – in cases of professional negligence. Discharge against medical advice – If a patient wants to leave against medical advice [LAMA], the dangers should be explained clearly in writing; then his wish should be recorded in the case sheet and his signatures obtained. Patient can then be discharged. In the discharge certificate, the doctor should specifically write the dangers of leaving hospital against medical advice.
  • 139. Kinds of Consent According to information provided to patient Uninformed consent -information completely or partly held back from patient. Illegal unless it falls within the concept of “therapeutic privilege” Informed consent According to the way patient communicates it to the doctor. Implied when patient’s actions imply consent. Here the consent is presumed (i.e. implied). [eg, telephoning, SMSing or emailing a doctor and asking for advice.]
  • 140. The consent is not written but legally it is effective The consent is provided for medical examination such as inspection, palpation and auscultation. It does not cover the consent for examination of # Private parts # Vein puncture or injection # Major intervention or operation.
  • 141. Express When patient specifically consents to examination either verbally or in writing. In other words, an expressed consent is one, which is stated, in distinct and explicit language. Required – in all procedures beyond routine physical examination [biopsies, Blood transfusions, LP, operations, Pleural and peritoneal tap etc] and must be taken before the act; not after it.
  • 142. A. Oral (verbal) consent It is consent, which is given verbally. This method is employed for minor procedures. Consent should be obtained in the presence of a disinterested third party for example nurse or receptionist Oral consent, when properly witnessed, is of equal validity that of written consent. Whenever oral consent is taken, it is appropriate to make an entry in the patient’s clinical record. Such precautions taken may be of use in future if any action is brought on the doctor by patient.
  • 143. B. Written Consent Here the consent is obtained in a written format. The doctor should explain the type of therapeutic procedure or surgical operation properly to the patient. Written consent afford documentary evidence When such consent is obtained after explaining the nature and consequences of the treatment procedure being contemplated, is called as informed consent.
  • 144. Miscellaneous kinds of consent Blanket consent – is one where the doctor takes consent from the patient for any and every possible diagnostic or treatment procedure that might have to be undertaken any time in the future. Since doctor himself is not sure of the kind of treatment that might be undertaken, patient cannot be explained of its risks etc. Many nursing homes and private hospitals, take blanket consent in the following manner “I hereby authorize staff of this hospital to perform any surgical or anesthetic procedure on me.” Blanket consent is invalid in the eyes of law.
  • 145. Proxy consent [substitute consent, surrogate consent] Consent given by a relative, next of kin or friend in case the patient himself cannot give consent [child <12 y, mentally unsound person, intoxication, unconsciousness etc.]
  • 146. Informed Consent Informed consent means that consent of patient for any procedure or treatment can only be taken after fully informing him about the nature of his condition. Components of an informed consent Disclosure Comprehension Absence of any outside control Competence Actual consent
  • 147. Disclosure Patient must be told (i) Nature - of his disease (ii) Options available – All treatments, costs, risks, benefits, success and failure rates, after-effects and prognosis of each (iii) In case of surgery (a) Whether it would be done under local or general anesthesia (b) Possible harmful effects of anesthesia (c) Details of operative procedures, relative benefits and risks (d) costs of each procedure (iv) Risks - of not receiving any treatment.
  • 148. Comprehension - Language - Explanation must be done in patient’s own language. If need be, an interpreter may be employed. Absence of any outside control over the decision– doctor, nurse, paramedical staff or any relative must not influence the decision. If patient voluntarily asks for advice, it may be given. Competence  patient should be above age of consent [>12y for GPE; >18 y for surgery  should be mentally sound  Should not be under influence of alcohol or drugs.
  • 149. Actual consent Written and witnessed - To make it legally acceptable, (a) Everything explained must be reduced to writing (b) Signatures of patient obtained (c) In presence of two independent witnesses to prevent any allegation that the consent was forged or obtained under compulsion or pressure.
  • 150. Principles which form the basis of informed consent Principle of full disclosure or patient’s right to truth. Principle of patient autonomy. Principle of full disclosure states that a doctor should reveal all information to the patient, regarding his disease, treatment options etc. Withholding information from a competent patient is a violation of the doctor’s role as a fiduciary and is not justified. Exceptions Doctor need not disclose risks of which he is himself unaware If the risk is so obvious that a person with normal intelligence can easily understand Therapeutic privilege
  • 151. Exceptions to informed consent Emergency [S.92, IPC]. Exactly same provisos apply for mentally unsound, intoxicated, persons <12 y and persons otherwise incapable of giving consent. Example Patient consents to laparotomy " during operation doctor discovers an unanticipated condition which endangers the life of patient " patient is under anesthesia " consent for the new operation cannot be taken " doctor undertakes procedure " protected u/s.92, IPC.
  • 152. This exception however does not extend to causing death. Example Doctor finds a lesion which would cause excruciating pain to patient, and he is sure, the patient cannot live for more than 6 months with the lesion. He decides to commit euthanasia to save unnecessary suffering. It is illegal. Therapeutic privilege Waiving of rights by patient – Patient expressly waives his right to informed consent to doctor.
  • 153. Informed Refusal The concept of informed refusal states that the doctor must inform the patient about the risks of refusing a particular operation, test, medication, or other medical intervention. Concept of informed refusal is inherent in informed consent It assumes importance only when the patient does not consent to treatment despite being informed of risks of refusal. To be legally valid, such informed refusal must be reduced to writing with signatures of patient, doctor and witness.
  • 154.
  • 155. Doctors and medical records Medical record [Health record, medical chart] is a document which records, documents and chronicles patient’s history, medical examination, laboratory and ancillary investigations, treatment advised, operation notes, discharge summary, details of subsequent visits and any other data regarding patient treatment.
  • 156. What Constitute Medical Record? OPD cards IPD cards Details of provisional and final diagnosis Treatment record X-ray films/USG report/CT scan/MRI films Laboratory reports Discharge and follow up record
  • 157. Medical Record is Required for Patients For claim of medical negligence cases For life insurance policy purpose For third party claims under health and accident insurance As a proof of disability Workman’s compensation cases Traffic accidents cases Follow-up cases or taking treatment from another doctor Medico-legal cases
  • 158. Medical Record is Required for Doctors/Hospitals For medical research For cost accounting Hospital audit Evaluation of drug therapy Planning Legal purpose Administration Follow-up cases Insurance claims
  • 159. Features of MR The medical record should be adequate, appropriate and complete. The patient or the representatives have got the right of access to their medical record. Well-maintained medical records will help the doctors and the hospitals to defend in medical negligence cases.
  • 160. MCI and Medical Record Indian Medical Council (professional conduct, etiquette and Ethics Regulations, 2002 (chapter 1, Section 1.3, subsection 1.3.1 and 1.3.2) states that: Every physician shall maintain the medical records pertaining to his/her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma lay down by the MCI.
  • 161. If any request is made for medical records either by the patients/authorized attendant or legal authorities involved, the same may be duly acknowledged and documents shall be issued within the period of 72 hours. Failure to maintain medical records for a period of three years or refuses to provide the same within 72 hours to the patient or his authorized representative will amount to misconduct.
  • 162. PRODUCTS LIABILITY Products liability occurs, when a manufacturer supplies a defective medical instrument or gadget (product) to the doctor or hospital; doctor inadvertently uses the defective product causing injury to the patient.
  • 163. Instances when product liability occurs Instruments Faulty, defective or negligently designed medical or surgical instruments [e.g. a defective defibrillator] wrong or inadequate operating instructions Medicines Components are incorrectly listed Potency too low or too high Wrong instructions of taking medication, e.g. oral medicine instructed to be instilled in eye Defective prosthetic devices Artificial heart valves, limbs etc. Pacemakers
  • 164. Legal duties of manufacturer (i) To use due care and research in development of all medical products, including medicines, medical and surgical instruments etc (ii) To perform studies of its product, when adverse reactions are reported in articles in scientific journals, and to report the results of these studies to physicians.
  • 165. When is manufacturer liable (i) Almost always, unless doctor used the instrument incorrectly (ii) With respect to medicines if harm was caused due to adulteration, contamination, incorrect dosage or wrong labeling of drug.
  • 166. When is doctor liable If the instrument functioned satisfactorily during previous operations. Incorrect use – by doctor. Wear and tear – occurred in the instrument either due to normal wear and tear, or due to mishandling by doctor or paramedical personnel. If the instrument was out of warranty, and required periodic inspection, testing and repairing and no request was sent to manufacturer for this. If instrument required periodic servicing and it was not sent for servicing.
  • 167. If doctor knew [or should have known] the dangerous side effects, and could have used a substitute drug, yet decided to use the dangerous drug for no plausible reason. If manufacturer has provided information in “package insert”, but doctor failed to convey it to patient. Once the manufacturer has made a warning in this manner it is the duty of doctor to convey this warning to the patient. Manufacturer has no duty to ensure that such warnings in the “package insert” reach the patient.
  • 168. MEDICAL INDEMNITY INSURANCE Medical Indemnity Insurance [Medical Malpractice Insurance] is a contract between the doctor and an insurance company, under which the latter agrees, in exchange for the payment of premiums, to indemnify [reimburse or compensate] the insured doctor against claims resulting from his professional negligence.
  • 169. Objects of MII To look after and protect the professional interests of the insured doctor. To arrange all other professional assistance including pre-litigation advice. To arrange, conduct and pay for the defense of such doctors. To indemnify the insured doctor arising from actions, claims and demands against him on grounds of professional negligence, misconduct, etc. When any dispute or allegation of negligence arises, the society must be contacted.
  • 170. MEDICOLEGAL ASPECTS OF HIV AND AIDS A. Civil Discrimination HIV+ve person can not be isolated, quarantined or discriminated against. Divorce U/s S.13(1) of Hindu Marriage Act, 1955, a person can get divorce, if spouse has been suffering from venereal disease in a communicable form. Employment According to India’s National Policy on HIV/AIDS, a person can neither be denied employment because of his HIV+ve status, nor can he be discriminated during service, nor can he be terminated from job solely due to HIV+ve status.
  • 171. B. Criminal Marriage or intercourse HIV +ve person A knowingly marries B [or performs intercourse] without informing B of his status " B catches infection " A can be sued u/s 269, IPC. S.269 may apply when the accused (a) Did not know he was HIV+ve (b) Did not understand how HIV is transmitted If accused disclosed his HIV+ve status to the person at risk [or honestly believed the other person was aware of his status], there may be no case.
  • 172. C. Rights of HIV+ve Patients An AIDS patient has the right to life and personal liberty [Art 21, Constitution of India]. It means that he has the right to treatment of his disease like any another person. They have the right to privacy. It means that they have the same right as other patients with regard to the disclosure of their disease status to other people and general public as a whole. In other words, one (doctor or hospital) can’t do things like putting labels on their beds indicating their HIV status. They cannot be isolated or quarantined on the basis of their disease. They cannot be discriminated in any sphere of life, including their job, due to their HIV status.
  • 173. D. Duty of Doctors Confidentiality Normally a doctor must maintain professional secrecy, but in case of HIV+ve patients, he can reveal the HIV+ve status to the prospective bride. In case of married couple, the status of married partner can be told to the spouse. The latter can then apply for divorce under provisions of the Hindu Marriage Act, 1955.
  • 174. Careful screening of blood For HIV status - before blood donation, transfusion, surgical operation or organ transplantation. Precautions (a) Screen living donors for HIV as close to the time of organ recovery and transplantation as possible, using sensitive tests for both chronic and acute infections, namely, serology and nucleic acid testing [NAT] (b) Inform transplant candidates of the potential risks for disease transmission (c) Advise donors that they have an obligation to avoid behaviors that would put them at risk for acquiring HIV before organ donation.
  • 175. Arguments in favor of routine screening (a) Charges of negligence – may be brought by the patient, if patient discovers after the operation that he is HIV +ve. He may allege that the infection was transmitted through these procedures. (b) Preoperative or pretransfusion screening will protect the doctor from such charges Arguments against routine screening (a) The accepted ethical standards of autonomy, confidentiality, and informed consent are broken. E. Miscellaneous Multiple tattooing with same needle may cause HIV transmission.
  • 176. S. 269, I.P.C.: Negligent act likely to spread infection of disease dangerous to life (imprisonment up to six months) S. 270, I.P.C.: Malignant act likely to spread infection of disease dangerous to life (imprisonment up to two years).
  • 177. CONSUMER PROTECTION ACT,1986 [Amendment in 1991, 1993, 2002] Consumer Protection Act (CPA) was enacted by Parliament in 1986 to provide better protection of the interests of consumers in the background of guidelines contained in the Consumer Protection Resolution passed by U.N. General Assembly on 9th April 1985.
  • 178. Aims and objectives To protect the interest of consumers - of different commodities [eg TV, car] and services [e.g. banking, airline travel etc.] Protection of consumer from hazards to their health and safety. Availability of effective consumer redressal forum. Cheap and speedy remedy.
  • 179.  The National Commission in 1993, in a ruling, includes medical services under the provisions of Consumer Protection Act (CPA).  In 1995, the Supreme Court of India (IMA vs V.P. Shantha) includes medical services under the ambit of CPA. The Apex Court arrived at the following conclusions Service rendered to patient by 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 medical and surgical would fall within the ambit of service as defined in section 2(1)(0) of the act.
  • 180. Structure and Functioning of Consumer Redressal Agencies Under CPA, the consumer dispute redressal agencies have been set up at three levels to provide speedy and inexpensive judicial remedies to the consumers. District Consumer Disputes Redressal Forum District level State Consumer Disputes Redressal Commission State level National Consumer Disputes Redressal Commission National level
  • 181. District Forum/Commission Composition District forum has three members. One chairman – a sitting or retired Sessions and District Judge Others two members are eminent citizens and amongst them one should be female. The age of the members should not be less than 35 years and they should possess at least some bachelor’s degree. The appointments are made by State government for a period of 5 years or up to age of 65 years whichever is earlier.
  • 182. Jurisdiction Original jurisdiction Entertain complains that does not exceed Rs. 20 lakhs State Forum/Commission Composition State Commission has three members. Presided by sitting or retired High Court Judge Other two members are eminent citizens and amongst them one should be female. Jurisdiction Original jurisdiction Appellate jurisdiction Revision jurisdiction Entertain complains that does not exceed 1 crore but over 20 lakhs
  • 183. National Forum/Commission Composition It is located at New Delhi and consists of 5 members. Presided by sitting or retired Supreme Court Judge Other four members are eminent citizens and amongst them one should be female. Jurisdiction Original jurisdiction Appellate jurisdiction Revision jurisdiction Entertain complains that exceed Rs. 1 crore.
  • 184. Manner of making complaints A complaint in relation to any goods sold or delivered or any service provided may be filed with a District Forum by (a) The consumer. If consumer dies, his legal hair or representative (b) Any recognized consumer association (c) One or more consumers, where there are numerous consumers having the same interest, with the permission of the District Forum (d) Central or the State Government. Every complaint must be accompanied by a fees prescribed by the State Govt [S.12].
  • 185. On receipt of a complaint The District Forum may allow the complaint to be proceeded with or rejected [after giving an opportunity to the complainant of being heard]. Admissibility of the complaint shall ordinarily be decided within 21 days from the date on which the complaint was received [S.12(3)]. Frivolous or vexatious complaints – are dismissed after recording the reasons in writing. The complainant may be asked to pay a cost of up to 10,000 to the opposite party [S.26].
  • 186. Procedure Trials (1) Speedy trials Every complaint is heard as early as possible and must preferably be decided within 3 months. No adjournment are ordinarily granted by DF unless sufficient cause is shown and the reasons for grant of adjournment have been recorded in writing by the Forum [S.13(3A)]. (2) If complaint refers to any service, the Forum shall refer a copy of such complaint to the opposite party directing him to give his version of the case within a period of 30 days. An extension of 15 days may be granted . Notices may be served even by FAX [S.28(2)].
  • 187. (3) It is not necessary for parties to be represented by lawyers. (4) Every proceeding before the DF shall be deemed to be a judicial proceeding within the meaning of S.193 and 228 of IPC, and DF shall be deemed to be a civil court.
  • 188. (5) Appeals against orders of District Forum Must be made to the State Commission within 30 days from the date of order. If there was sufficient cause for appeal later than 30 days, State Commission can entertain it. Fees - appellant must deposit 50% of amount ordered by DF or `25,000 whichever is less [S.15]
  • 189. (6) Appeals against orders of State Commission Must be made to the National Commission within 30 days from the date of order. If there was sufficient cause for appeal later than 30 days, National Commission can entertain it. Fees - appellant must deposit 50% of amount ordered by SC or 35,000 whichever is less [S.19].
  • 190. (7) Appeals against orders of National Commission National Commission is empowered to review its orders to avoid rush to the Supreme Court However even if review does not give relief to a party, the appeal must be made to the Supreme Court within 30 days from the date of order. If there was sufficient cause for appeal later than 30 days, Supreme Court can entertain it Fees - appellant must deposit 50% of amount ordered by SC or $ 50,000 whichever is less [S.23].
  • 191. (8) Ensuring payment of compensation To ensure payment of compensation, the Consumer Courts [DF, SC, NC] can attach the property of the opposite party and dispose it to recover amount due to the complainant. District Collector would help the courts to recover this amount. (9) Finality of orders If no appeal has been preferred against order of a DF, SC or NC, such order shall be final [S.24].
  • 192. Limitation period The District Forum, the State Commission or the National Commission normally will not admit a complaint unless it is filed within 2 years from the date on which negligence was committed. But under special circumstances complaints after 2 years may be entertained if the Forum or Commission is satisfied that there is sufficient reason for doing so, and it must record in writing, the reasons for entertaining such late complaints [S.24A].
  • 193. Who is covered under COPRA All doctors and hospitals who have charged for their service. All doctors and hospitals [including Govt hospitals, health centers, dispensaries etc] who perform partial charitable services, i.e. who charge from few patients only [rich] and other [poor] are not charged. All [both rich and poor] can get benefit under COPRA.
  • 194. Who is immune from COPRA Doctors and hospitals [including Govt hospitals] which are doing a completely charitable service not charging anyone [i.e. neither rich nor poor are charged]. Hospitals charging a token amount for registration purpose only – It is not payment for the purposes of COPRA.
  • 195. THE WORKMEN’S COMPENSATION ACT, 1923 The Workmen’s Compensation Act, 1923 [WCA, 1923] is one of the earliest labor welfare and social security legislation enacted in India. This Act provides for the payment of compensation to workmen for injuries sustained by them in an accident, arising out of and in the course of employment.
  • 196. Aims and objectives Provides compensation to workmen and their dependents - in case of accidents arising out of and in the course of employment causing death or disablement of workmen. The amount of compensation depends upon whether the injury has caused death, permanent total disablement or permanent partial disablement.
  • 197. The employer will not be liable to pay compensation in respect of any injury which results in death or permanent total disablement caused by an accident, if the workman at the time of sustaining injury was under the influence of drink or drugs or willfully disregarded or removed any safety guard or other device provided for his safety.
  • 198. THANKS