CONSUMER PROTECTION ACT FOR CONSUMER PROTECTION ACT FOR

MEDICAL PROFESSION IN INDIA MEDICAL PROFESSION IN INDIA

Dr. Bipin PanditDr. Bipin PanditMD.DGO.DFPMD.DGO.DFP

Hon. Gynaecologist at Dr. Balabhai Nanavatii Hospital, V ParleHon. Gynaecologist at Dr. Balabhai Nanavatii Hospital, V ParleHon. Gynaecologist at Dr. L.H. Hiranandani Hospital, PowaiHon. Gynaecologist at Dr. L.H. Hiranandani Hospital, PowaiHon. Gynaecologist at Municipal Maternity Hospital, MarolHon. Gynaecologist at Municipal Maternity Hospital, Marol

Hon. Gynaecologist at L & T Welfare Center Andheri.Hon. Gynaecologist at L & T Welfare Center Andheri.

Chairman Medico-legal committee MOGSChairman Medico-legal committee MOGSPast President of Association Of Medical Consultants MumbaiPast President of Association Of Medical Consultants Mumbai

Committee Member of Indian Education Society.Committee Member of Indian Education Society.Past President Andheri Medical Association (E & W) Past President Andheri Medical Association (E & W)

Time line Time line

Guidelines for good medical practice across the ages :Guidelines for good medical practice across the ages :

The Code of HammurabiThe Code of Hammurabi ( 2000 B.C. ( 2000 B.C. ) )

Park’s textbook of PSM,16th edition

Time line….Time line…. The Hippocratic Oath (460-370 B.C.)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)…”

Park’s textbook of PSM,16th edition

Time line…..

CHARAK’S OATH (200 A.D.)CHARAK’S OATH (200 A.D.)

““Thou shalt be free from envy, not cause another’s 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 patient’s house, be accompanied by a person known to the patient. The peculiar customs of the patient’s household shall not be made public. "

Park’s textbook of PSM,16th edition

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

Adab al – TabibAdab al – Tabib

Park’s textbook of PSM,16Park’s textbook of PSM,16thth edition edition

Time line …..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 Medical Dilemma A profession in retreat.A profession in retreat.

Professional dissatisfactionProfessional dissatisfaction

Fuzzy science, awkward art.Fuzzy science, awkward art.

Doctors give hope, not perform miraclesDoctors give hope, not perform miracles..

THE WOUNDED HEALERTHE WOUNDED HEALER..

Abigail Zuger . Dissatisfaction with medical practice. NEJM Vol 350, 69-75, Abigail Zuger . Dissatisfaction with medical practice. NEJM Vol 350, 69-75, Jan. 2004Jan. 2004

Consumer Dispute Forum

Medical Council

Civil Court Criminal Court

WHERE TO GO ?

WHY CPA?WHY CPA? MCI

Biased

Can’t award

damages

THE COURTS

Delay

Expensive

The answer – Alternate dispute resolution system –

Easy, quick, accessible, cheap and effective

Sec 3A, 12, CPA 1986

Consumer Protection Act, 1986Consumer Protection Act, 1986

Empowers the consumer with the Right to :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 AgenciesConsumer Disputes Redressal AgenciesDISTRICT FORUMDISTRICT FORUM

Jurisdiction Upto Rs. 20 lakhs

Composition President + 2 Members

Powers Examines complaintsIssues notices Orders analysis / tests Conducts hearings

Award damages

Sec 9 to 15 of THE CPA ( Amendment ), 2002

Consumer Disputes Redressal AgenciesConsumer Disputes Redressal AgenciesSTATE COMMISSION 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 AgenciesConsumer Disputes Redressal AgenciesNATIONAL COMMISSIONNATIONAL 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: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.

Parikh’s Textbook of Medical Jurisprudence, Forensic medicine.

Types of Professional Negligence:Types of Professional Negligence:

Civil Negligence: Malpractice, Deficiency in Service

Criminal Negligence: gross lack of competency, gross inattention reckless behavior

In In generalgeneral a doctor's a doctor's innocence is presumedinnocence is presumed

The complainant has to prove The complainant has to prove negligence.negligence.

Proof of NegligenceProof of Negligence

4 D’s4 D’s

The essentials of negligence are four "D"s:

1. There was a Duty towards patients;2. There was Deficiency in duty3. 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 another’s 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.

A patient’s A patient’s journey journey

through the through the realm of realm of medical medical

malpracticemalpractice

Quality of care

Commitment of medical error

A Doctor’s Defense

Outcome: judgment and awards

Quality of CareQuality of Care

Patient - Doctor Relationship Patient - Doctor Relationship

( Implied contract ) ( Implied contract )

The Sacred Patient-The Sacred Patient-Doctor Relationship – A Doctor Relationship – A

thing of the pastthing of the past

Caring and healing.Caring and healing.

Patient - Doctor Patient - Doctor Relationship Relationship

( Implied contract ) ( Implied contract ) An implied contract between patient (consumer) and An implied contract between patient (consumer) and

doctor( service provider) for a consideration ( fee ).doctor( service provider) for a consideration ( fee ).

Not established :Not established : While giving first aid in emergencyWhile giving first aid in emergency Pre-employment medical examinationPre-employment medical examination Examining a patient under court orderExamining a patient under court order

Parikh’s Textbook of Medical Jurisprudence Forensic medicine

Requirements of Doctor Requirements of Doctor Patient RelationshipPatient 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 condition may requiremay requireCommunication

Too little time for patients Does not listen Does not explain well Shows no sympathy Neither understands the

patient nor his family

Common Patient Common Patient ComplaintsComplaints

Harris Poll, 2000 Roper Center Polls, 2000

Hey, DOC

!

““Informed” ConsentInformed” Consent

How well do How well do you you

understand understand it?it?

Informed ConsentInformed Consent

IMPLIES:IMPLIES:

Understanding by the patientUnderstanding by the patient • Natural history of the disease.Natural history of the disease.• Nature of proposed treatment. Nature of proposed treatment. • Anticipated prognosis of the proposed intervention.Anticipated prognosis of the proposed intervention.• Expected side effects.Expected side effects.• Unexpected hazards.Unexpected hazards.• Any alternative and potentially successful treatment.Any alternative and potentially successful treatment.• Consequences of no treatment at allConsequences of no treatment at all..

Bailey and Love’s Short Practice of Surgery, 24th Edition

Types of consentTypes of consent

Implied : inferred from actions

Express : actively stated

Proxy consent : on behalf of others

Why is Consent Why is Consent NecessaryNecessary

Willing patient,

better outcome

defense against a charge of assault / battery

When is Consent When is Consent NecessaryNecessary

Everything in the Doctor - Patient Relationship is CONSENSUAL

Express Consent is Express Consent is expected..expected..

Surgical/Invasive Procedures

Chemotherapy / Radiotherapy

Radiological / Investigational Procedures

Medical Research

Teaching - intimate examination

Competence/Capacity in Competence/Capacity in Informed ConsentInformed 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: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.

WhyWhy do patients sue? do patients sue? ““Original injury is not enough.”Original injury is not enough.”

Prime concern: perceived lack of caringPrime concern: perceived lack of caring

3 reasons for litigation3 reasons for litigation1)1) Altruism – protect othersAltruism – protect others2)2) Expose the truthExpose the truth3)3) Financial restitution. Financial restitution.

Lack of communication. Lack of communication.

Over 1/3 would have opted out of litigation with Over 1/3 would have opted out of litigation with explanation, apologyexplanation, apology

Vincent, Young, Philips, “Why do people sue doctors?” Lancet, 1994

How does fear of lawsuits How does fear of lawsuits alter patient care?alter patient care?

definition

Defensive Medicine – the use of costly 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 !!Fear of the patient !!Altered patient-doctor Altered patient-doctor

relationshiprelationship 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”IOM - “To Err Is Human”The American health care system The American health care system is not as safe as you might thinkis not as safe as you might think

#1 – #1 – deaths by medical errordeaths by medical error

#2 – motor vehicle collisions#2 – motor vehicle collisions

#3 – breast cancer#3 – breast cancer

#4 – AIDS#4 – AIDS

44,000 - 98,000 deaths by 44,000 - 98,000 deaths by PREVENTABLEPREVENTABLE medical errors in medical errors in hospitals each yearhospitals each year

Institute of Medicine, “To Err is Human: Building a Safer Health System,” Nov 1999Institute of Medicine, “To Err is Human: Building a Safer Health System,” Nov 1999Harvard School of Public Health, from Testimony of Harvey Rosenfield, FTCR, Feb 2003Harvard School of Public Health, from Testimony of Harvey Rosenfield, FTCR, Feb 2003Jrnl of Health Care Info Management, “A System Approach the Error Reporting,” Vol. 16, No. 1Jrnl of Health Care Info Management, “A System Approach the Error Reporting,” Vol. 16, No. 1

Types of Deadly Medical Errors in 1997

44%

17%12%

10%

17%

Technical errors DiagnosisFailure to prevent injury DrugsOthers

To err is human : Building a safer health system, IOM, 2000

ALLEGATIONS THE SURGEON Articles left in patient’s body.

Consent not taken prior to operation.

Operation on wrong side.

Failure in diagnosis or operation.

Not operating in time.

ANAESTHESIOLOGIST

Excessive anesthesia

Injury to eyes/skin

Injury from mask/mouth gag

Allegations…

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

MEASURESPREVENTION AT PREVENTION AT PERSONAL LEVELPERSONAL LEVELQualificationQualificationCommunicationCommunication

INTERPERSONAL LEVELINTERPERSONAL LEVELCourteous and polite if Courteous and polite if any mishapany mishap

ACADEMIC AND TECHNICALACADEMIC AND TECHNICALUP GRADATIONUP GRADATIONAttend CME,Workshops and Conferences

PREVENTION AT PRACTICEMEDICAL

Reasonable skill and care

SOCIAL

Exhibit skill to patient: body language

LEGAL

Document in legible handwriting

Record of failure

OTHER MEASURESOTHER MEASURESPEOPLE SUPPORT GROUPSPEOPLE SUPPORT GROUPS

Forum to discuss acts and cases fought Never talk loose of your colleague

MEDICAL ETHICS

Thorough knowledge is a must

PROFESSIONAL INDEMNITYPROFESSIONAL INDEMNITY

Insurance

DO’S AND DON’TS FOR DO’S AND DON’TS FOR DOCTORSDOCTORS

HISTORY TAKINGDO’S Listen attentively

Maintain privacy

Face patient

Start afresh if distraction

Ask questions intelligently

Give time to the patient

HISTORY TAKINGDON’TS

Don’t discriminate.

Don’t assume all what patient says as correct

Don’t smoke

Don’t look overconfident

EXAMINATION OF PATIENTEXAMINATION OF PATIENTDO’SDO’S

Thoroughly examine the pt.

Oblige again if patient considers examination incomplete

Review next day if patient is examined hurriedly

EXAMINATION OF PATIENTDON’TS

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

PRESCRIPTIONPRESCRIPTIONDO’SDO’S

MENTION: Qualification/training/experience/designation

(Indian Medical Degree Act’1916)

Date and timing of the consultation

Age and sex of patient

Precise history of illness/physical finding

Diagnosis under review if unsettled

PRESCRIPTIONPRESCRIPTIONDO’S(cont..)DO’S(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.

PRESCRIPTIONPRESCRIPTIONDO’S(cont..)DO’S(cont..)

MENTION :

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

PRESCRIPTIONPRESCRIPTIONDO’S(cont..)DO’S(cont..)

MENTION :

Reasons for deviation from standard

care

Prognosis explained

Where patient should contact if you

are unavailable

Review SOS.

PRESCRIPTIONPRESCRIPTIONDON’ TSDON’ TS

Don’t prescribe : without examination/ banned drugs/ for experimental reasons.

Don’t write : multiple drugs/instructions on separate slip.

Don't allow substitutions.

INVESTIGATIONSDO’S

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.

INVESTIGATIONSINVESTIGATIONSDON’TSDON’TS

Never order an investigation unless result is likely to help direct treatment

Don’t allow modern diagnostic test to substitute your clinical judgment

Don’t inform patient has HIV till confirmatory test is done

MANAGEMENTDO’S

Update with latest management by attending CME and conferences

Employ qualified assistants Update facilities and equipment

Obtain legally valid consent before any procedure

MANAGEMENTDO’S(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

MANAGEMENTMANAGEMENTDON’TSDON’TS

Don’t perform procedures in agitated patients eg. broken needle can be a cause for law suit

Don’t forget to count swab and instruments when ending operation

Don’t hesitate to take senior’s or colleague help if in trouble

Don’t deny medical care to HIV positive

NEVER AVOID EMERGENCY CALLS

OTHEROTHERDO’SDO’S

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

OTHEROTHERDON’TSDON’TS

Don’t refuse leave against medical advise

Don’t withhold information however harsh and difficult(sensitive communication)

Don’t refuse patient’s right to examine and receive an explanation about your bills

Outcome: judgment Outcome: judgment and awardsand awards

Patient injured

Claim filed

Case to trial

Court verdict

Verdict for plaintiff

Award designated

98.5%

1.5%92-87%

8-13%93%

7%81%

19%

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

“Litigation lottery” and frivolous law suits?

Doctor’s Indemnity

Why do doctors need insurance anyway?

Peace of mindPeace of mind

Insurance does not coverInsurance 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 InsuranceOther Problems With Insurance

High premiums High premiums

Do not pay whole of the damages Do not pay whole of the damages Lot of running aroundLot of running around Defense lawyer in the insurance co.panel lacksDefense lawyer in the insurance co.panel lacks adequate medico-legal knowledgeadequate medico-legal knowledge Patients are encouraged to go in for litigationPatients are encouraged to go in for litigation

The Best Insurance PolicyThe Best Insurance Policy

THE 3 C’s:

CARE

CONCERN

CONSIDERATION

Faith is the only currency between a doctor and a patient ( Dr. K. C. Mahajan FRCS)