CONSUMER PROTECTION ACT FOR

MEDICAL PROFESSION IN INDIA

Dr. Bipin Pandit
MD.DGO.DFP

Hon. Gynaecologist at Dr. Balabhai Nanavatii Hospital, V Parle

Hon. Gynaecologist at Dr. L.H. Hiranandani Hospital, Powai
Hon. Gynaecologist at Municipal Maternity Hospital, Marol
Hon. Gynaecologist at L & T Welfare Center Andheri.

Chairman Medico-legal committee MOGS

Past President of Association Of Medical Consultants Mumbai
Committee Member of Indian Education Society.
Past President Andheri Medical Association (E & W)
 Time line
Guidelines for good medical practice across the ages :

The Code of Hammurabi ( 2000 B.C. )

Parks textbook of PSM,16th edition

 Time line.
The Hippocratic Oath (460-370 B.C.)
I swear by Apollo the
healer, by Asclepius, by
Health, by Panacea and by
all the gods and goddesses,
making them my witnesses
that I will carry out to the
best of my ability and
judgment this oath and this
covenant (horkos kai
syngraphe)
Parks textbook of PSM,16th edition
 Time line..
CHARAKS OATH (200 A.D.)
Thou shalt be free from envy, not cause anothers
death, and pray for the welfare of all creatures. Day
and night thou shalt not desert a patient, nor commit
adultery, be modest in thy attire and appearance, not to
be drunkard or sinful, while entering a patients house,
be accompanied by a person known to the patient. The
peculiar customs of the patients household shall not be
made public. "

Parks textbook of PSM,16th edition

 Time line ..
ARABIC CODE OF MEDICAL ETHICS (800-1300 AD)

Adab al Tabib

Parks textbook of PSM,16th edition

 Time line ..

The Declaration of Geneva 1948

The Indian Medical Council Act 1956

The Consumer Protection Act 1986

The inclusion of medical services in CPA 1995

 Medical Dilemma
A profession in retreat.

Professional dissatisfaction

Fuzzy science, awkward art.

Doctors give hope, not perform miracles.

THE WOUNDED HEALER.

Abigail Zuger . Dissatisfaction with medical practice. NEJM Vol 350, 69-75, Jan. 2004
 WHERE TO GO ?
Consumer Dispute Forum

Civil Court Criminal Court

Medical Council
 WHY CPA?
MCI THE COURTS

Biased Delay
Cant award Expensive
damages

The answer Alternate dispute resolution system

Easy, quick, accessible, cheap and effective
Sec 3A, 12, CPA 1986
 Consumer Protection Act, 1986
Empowers the consumer with the Right to :
Safety
Information

Choose

Heard

Redressal

Consumer education

Sec 4 to 8 of The CPA ( Amendment ), 2002

 LODGING A COMPLAINT
FORMAT: Written
PERSON : Complainant / Representative
PLACE : Consumer Dispute Redressal Fora
FEE : Nominal
TIME LIMIT : 2 yrs
FATE : Accepted
Dismissed

Sec 12 CPA 1986

 Consumer Disputes Redressal Agencies
DISTRICT FORUM
Jurisdiction Upto Rs. 20 lakhs

Composition President + 2 Members

Powers Examines complaints

Issues notices
Orders analysis / tests
Conducts hearings
Award damages
Sec 9 to 15 of THE CPA ( Amendment ), 2002
 Consumer Disputes Redressal Agencies
STATE COMMISSION
Jurisdiction From 20 lakhs Up to 1Crore

Composition President + 2 Members

Power Similar to district forum

+
Hearing of appeals

Sec 16 to 19 of The CPA ( Amendment ), 2002

 Consumer Disputes Redressal Agencies
NATIONAL COMMISSION

Jurisdiction > Rs. 1 Crore

Composition President + 4 members

Powers Similar to State forum

+
Hearing of appeals

Sec 20 to 25 of The CPA ( Amendment ), 2002

 Professional Negligence:
Definition:

Absence of reasonable care or skill or willful negligence

on the part of the medical practitioner in the treatment

of the patient whereby the health or life of the patient is

endangered.

Parikhs Textbook of Medical Jurisprudence, Forensic medicine.

 Types of Professional Negligence:

Civil Negligence: Malpractice, Deficiency in

Service

Criminal Negligence: gross lack of competency,

gross inattention
reckless behavior
 In general a doctor's
innocence is presumed

The complainant has to prove

negligence.
 Proof of Negligence
4 Ds
The essentials of negligence are four "D"s:

1. There was a Duty towards patients;

2. There was Deficiency in duty
3. This Directly resulted in (causa causans )
4. Damage which may be physical, mental or
financial loss to patient or relatives.

Tiwari S.K, Baldwa M. - Medical Negligence.

Indian Pediatrics 2001; 38: 488-495
 Res Ipsa Loquitur

The thing or the fact speaks for itself.

Error is so self evident that the doctor has to

prove his innocence.

E.g., Amputation of right instead of left leg.

 Vicarious Liability

Liability for anothers act.

A doctor is responsible for not only his own negligence

but also for the negligence of his employees, if such an
act occurs under his direct supervision, by the principle
of Respondent Superior.
 Quality of care
A patients
journey
through the Commitment of
realm of medical error
medical
malpractice A Doctors
Defense

Outcome: judgment
and awards
 Quality of Care
Patient - Doctor Relationship
( Implied contract )
 The Sacred Patient-Doctor
Relationship A thing of the past

Caring and healing.

 Patient - Doctor Relationship
( Implied contract )
An implied contract between patient (consumer) and
doctor( service provider) for a consideration ( fee ).

Not established :
While giving first aid in emergency

Pre-employment medical examination

Examining a patient under court order

Parikhs Textbook of Medical Jurisprudence Forensic medicine

Requirements of Doctor Patient
Relationship
Reasonable skill
An average degree of skill
possessed by his professional
brethren of the same standing

Reasonable care
Such care and attention for the
safety of the patient as their
mental and physical condition
may require
Communication
 Common Patient Complaints
Hey,
Too little time for patients DOC
Does not listen !
Does not explain well
Shows no sympathy
Neither understands the
patient nor his family

Harris Poll, 2000 Roper Center Polls, 2000

Informed Consent

How well do
you
understand
it?
 Informed Consent
IMPLIES:
Understanding by the patient
Natural history of the disease.
Nature of proposed treatment.
Anticipated prognosis of the proposed intervention.
Expected side effects.
Unexpected hazards.
Any alternative and potentially successful treatment.
Consequences of no treatment at all.

Bailey and Loves Short Practice of Surgery, 24th Edition

 Types of consent
Implied : inferred from actions

Express : actively stated

Proxy consent : on behalf of others

Why is Consent Necessary

Willing patient,
better outcome

defense against a
charge of assault /
battery
When is Consent Necessary
Everything in the Doctor - Patient
Relationship is CONSENSUAL
 Express Consent is expected..
Surgical/Invasive Procedures
Chemotherapy / Radiotherapy
Radiological / Investigational
Procedures
Medical Research
Teaching - intimate
examination
 Competence/Capacity in
Informed Consent
Competent Adult ( > 18 yrs )

In case of Minors ( < 12 yrs ) Parent or legal

guardian( Loco Parents ).

Emergency ( the law implies consent )

(Sec.92.I.P.C.)
Rules Of Consent:
Consent - in the presence of a disinterested third
party, e.g., a nurse.

Consent should not be a blanket permission.

In criminal cases the victim/assailant cannot be

examined without his/her consent.
Consent given for illegal acts is invalid.
When an operation is made compulsory by law,
e.g. vaccination, the law provides the consent.

The law of Medical Negligence Dr. H. L. Chulani, 1996.

 Why do patients sue?
Original injury is not enough.

Prime concern: perceived lack of caring

3 reasons for litigation

1) Altruism protect others
2) Expose the truth
3) Financial restitution.

Lack of communication.

Over 1/3 would have opted out of litigation with

explanation, apology
Vincent, Young, Philips, Why do people sue doctors? Lancet, 1994
How does fear of lawsuits
alter patient care?
 Defensive Medicine the use of costly
definition
diagnostic efforts of medical treatments for the
sole purpose of avoiding potential litigation
Litigation has decreased quality of care

More tests than medically needed

More specialist referrals than needed

More invasive procedures than needed

More medicines than needed

Fear of Litigation study, Harris Interactive, Apr 2002

 Fear of the patient !!
Altered patient-doctor relationship
Potentially adversarial
relationship
Each patient a potential
plaintiff
Each question a possible
source of angst
Doctors who worry about
being sued probably will
be.

Lown, Bernard, MD, The Lost Art of Healing: Practicing Compassion in Medicine, 1999
 IOM - To Err Is Human
The American health care system
is not as safe as you might think
#1 deaths by medical error
#2 motor vehicle collisions
#3 breast cancer
#4 AIDS

44,000 - 98,000 deaths by PREVENTABLE

medical errors in hospitals each year
Institute of Medicine, To Err is Human: Building a Safer Health System, Nov 1999
Harvard School of Public Health, from Testimony of Harvey Rosenfield, FTCR, Feb 2003
Jrnl of Health Care Info Management, A System Approach the Error Reporting, Vol. 16, No. 1
 Types of Deadly Medical Errors in 1997

17%
10% 44%

12%
17%

Technical errors Diagnosis

Failure to prevent injury Drugs
Others
To err is human : Building a safer health system, IOM, 2000
 ALLEGATIONS
THE SURGEON
Articles left in patients body.

Consent not taken prior to

operation.

Operation on wrong side.

Failure in diagnosis or
operation.

Not operating in time.

 Allegations
ANAESTHESIOLOGIST

Excessive anesthesia

Injury to eyes/skin

Injury from mask/mouth gag

 Allegations
RADIOLOGIST

Electrical shock & burns

Injuries to vision

Pigmentation

Loss of hairs
 GYNAECOLOGIST
Consent not taken before abortion

Failed tubal ligation

Injury to uterus

Operation causing sterility

 MEASURES
PREVENTION AT
PERSONAL LEVEL
Qualification
Communication

INTERPERSONAL LEVEL
Courteous and polite if
any mishap

ACADEMIC AND TECHNICAL

UP GRADATION
Attend CME,Workshops and
Conferences
 PREVENTION AT PRACTICE
MEDICAL

Reasonable skill and care

SOCIAL

Exhibit skill to patient: body language

LEGAL

Document in legible handwriting

Record of failure
 OTHER MEASURES
PEOPLE SUPPORT GROUPS
Forum to discuss acts and cases fought
Never talk loose of your colleague
MEDICAL ETHICS
Thorough knowledge is a must
PROFESSIONAL INDEMNITY
Insurance
 DOS AND DONTS FOR
DOCTORS
HISTORY TAKING
Listen attentively DOS
Maintain privacy

Face patient

Start afresh if distraction

Ask questions intelligently

Give time to the patient

 HISTORY TAKING
DONTS
Dont discriminate.

Dont assume all what patient says as

correct

Dont smoke

Dont look overconfident

 EXAMINATION OF PATIENT
DOS

Thoroughly examine the pt.

Oblige again if patient considers examination incomplete

Review next day if patient is examined hurriedly

 EXAMINATION OF
PATIENT
DONTS
Don't examine if you are:
sick
exhausted
intoxicated

NEVER examine a female

patient in the absence of a
female nurse or an attendant
especially during genital or
breast examination
 PRESCRIPTION
DOS
MENTION:
Qualification/training/experience/designation
(Indian Medical Degree Act1916)

Date and timing of the consultation

Age and sex of patient

Precise history of illness/physical finding

Diagnosis under review if unsettled

 PRESCRIPTION
DOS(cont..)
MENTION :

Refusal for investigation/administration in

local language with proper witness

H/O drug allergy

Names/dosage/route of administration of drugs

clearly with precautions like ac/pc.
 PRESCRIPTION
MENTION :
DOS(cont..)
If patient is pregnant/lactating

Side effect/interaction of drug

Emergency treatment in chronic illness

Not to stop drug suddenly if tapering required

If a particular drug/equipment unavailable

 PRESCRIPTION
DOS(cont..)
MENTION :

Reasons for deviation from standard

care

Prognosis explained

Where patient should contact if you

are unavailable

Review SOS.
 PRESCRIPTION
DON TS
Dont prescribe : without
examination/ banned drugs/
for experimental reasons.

Dont write : multiple

drugs/instructions on
separate slip.

Don't allow substitutions.

 INVESTIGATIONS
DOS
Analyse cost benefit ratio

Read reports carefully

and interpret results of
tests/X-rays properly

Rule out pregnancy before

subjecting uterus to X-ray

Consent-invasive invest.
 INVESTIGATIONS
DONTS
Never order an investigation unless result is likely
to help direct treatment

Dont allow modern diagnostic test to substitute

your clinical judgment

Dont inform patient has HIV till confirmatory

test is done
 MANAGEMENT

DOS
Update with latest management
by attending CME and
conferences

Employ qualified assistants

Update facilities and equipment

Obtain legally valid consent

before any procedure
 MANAGEMENT
DOS(contd..)
In case of MTP/sterilization, follow
guide lines issued by Govt of India

Ensure proper post - operative care

Relieve pain specially in cancer

patients
 MANAGEMENT
DONTS
Dont perform procedures in agitated patients eg.
broken needle can be a cause for law suit

Dont forget to count swab and instruments when

ending operation

Dont hesitate to take seniors or colleague help if

in trouble

Dont deny medical care to HIV positive

NEVER AVOID EMERGENCY CALLS

 OTHER
DOS

Extend your sympathy to bereaved family

Label a condition as functional only when

other causes are ruled out

Issue certificates only when full verification is

done
 OTHER
DONTS
Dont refuse leave against medical advise

Dont withhold information however harsh

and difficult(sensitive communication)

Dont refuse patients right to examine and

receive an explanation about your bills
Outcome: judgment
and awards
Award
designated
Verdict
for 19%
plaintiff

Court
7%
81% verdict

Case to
8-13%
93% trial
Litigation
Claim
lottery and 92-87% filed
1.5%

frivolous law
suits? Patient
98.5% injured

Hyatt, et al, A study of medical injury and med mal: an overview, NEJM, 1989
 Doctors Indemnity

Why do doctors need insurance

anyway?

Peace of mind
 Insurance does not cover
Any Criminal act

Services rendered while intoxicated

Any procedure under GA outside hospital

Use of miracle drugs

Cosmetic surgery
Other Problems With Insurance
High premiums

Do not pay whole of the damages

Lot of running around

Defense lawyer in the insurance co.panel lacks

adequate medico-legal knowledge

Patients are encouraged to go in for litigation

 The Best Insurance Policy
THE 3 Cs:
CARE

CONCERN

CONSIDERATION

Faith is the only currency between a doctor and a patient

( Dr. K. C. Mahajan FRCS)