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CONSUMER PROTECTION ACT FOR MEDICAL PROFESSION IN INDIA Dr. Bipin Pandit MD. DGO. DFP 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 : n The Code Time line Guidelines for good medical practice across the ages : n The Code of Hammurabi ( 2000 B. C. ) Park’s textbook of PSM, 16 th edition

Time line…. n The Hippocratic Oath (460 -370 B. C. ) • “I swear Time line…. n 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, 16 th edition

Time line…. . n CHARAK’S OATH (200 A. D. ) “Thou shalt be free Time line…. . n 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, 16 th edition

Time line …. . ARABIC CODE OF MEDICAL ETHICS (800 -1300 AD) Adab al Time line …. . ARABIC CODE OF MEDICAL ETHICS (800 -1300 AD) Adab al – Tabib Park’s textbook of PSM, 16 th edition

Time line …. . n The Declaration of Geneva 1948 n The Indian Medical Time line …. . n The Declaration of Geneva 1948 n The Indian Medical Council Act 1956 n The Consumer Protection Act 1986 n The inclusion of medical services in CPA 1995

Medical Dilemma n A profession in retreat. n Professional dissatisfaction n Fuzzy science, awkward Medical Dilemma n A profession in retreat. n Professional dissatisfaction n Fuzzy science, awkward art. n Doctors give hope, not perform miracles. n 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 WHERE TO GO ? Consumer Dispute Forum Civil Court Criminal Court Medical Council

WHY CPA? n MCI Biased Can’t award damages n THE COURTS Delay Expensive The WHY CPA? n MCI Biased Can’t award damages n THE COURTS Delay Expensive The answer – Alternate dispute resolution system – Easy, quick, accessible, cheap and effective Sec 3 A, 12, CPA 1986

Consumer Protection Act, 1986 Empowers the consumer with the Right to : Safety n Consumer Protection Act, 1986 Empowers the consumer with the Right to : Safety n Information n Choose n Heard n Redressal n Consumer education n Sec 4 to 8 of The CPA ( Amendment ), 2002

LODGING A COMPLAINT n FORMAT: Written n PERSON : Complainant / Representative n n LODGING A COMPLAINT n FORMAT: Written n PERSON : Complainant / Representative n n PLACE : FEE : Consumer Dispute Redressal Fora Nominal n TIME LIMIT : ≤ 2 yrs n FATE : Sec 12 CPA 1986 Accepted Dismissed

Consumer Disputes Redressal Agencies DISTRICT FORUM n Jurisdiction Upto Rs. 20 lakhs n Composition Consumer Disputes Redressal Agencies DISTRICT FORUM n Jurisdiction Upto Rs. 20 lakhs n Composition President + 2 Members n 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 n Jurisdiction From 20 lakhs Up to 1 Consumer Disputes Redressal Agencies STATE COMMISSION n Jurisdiction From 20 lakhs Up to 1 Crore n Composition President + ≥ 2 Members n Power Similar to district forum + Hearing of appeals Sec 16 to 19 of The CPA ( Amendment ), 2002

Consumer Disputes Redressal Agencies NATIONAL COMMISSION n Jurisdiction > Rs. 1 Crore n Composition Consumer Disputes Redressal Agencies NATIONAL COMMISSION n Jurisdiction > Rs. 1 Crore n Composition President + ≥ 4 members n 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 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. Parikh’s Textbook of Medical Jurisprudence, Forensic medicine.

Types of Professional Negligence: n Civil Negligence: Malpractice, Deficiency in Service n Criminal Negligence: Types of Professional Negligence: n Civil Negligence: Malpractice, Deficiency in Service n Criminal Negligence: gross lack of competency, gross inattention reckless behavior

In general a doctor's innocence is presumed The complainant has to prove negligence. In general a doctor's innocence is presumed The complainant has to prove negligence.

Proof of Negligence 4 D’s The essentials of negligence are four Proof of Negligence 4 D’s The essentials of negligence are four "D"s: 1. 2. 3. 4. There was a Duty towards patients; There was Deficiency in duty This Directly resulted in (causans ) 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 n “The thing or the fact speaks for itself. ” n Res Ipsa Loquitur n “The thing or the fact speaks for itself. ” n Error is so self evident that the doctor has to prove his innocence. n E. g. , Amputation of right instead of left leg.

Vicarious Liability n Liability for another’s act. n A doctor is responsible for not Vicarious Liability n Liability for another’s act. n 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 patient’s journey through the realm of medical malpractice Commitment of Quality of care A patient’s journey through the realm of medical malpractice Commitment of medical error A Doctor’s Defense Outcome: judgment and awards

Quality of Care Patient - Doctor Relationship ( Implied contract ) Quality of Care Patient - Doctor Relationship ( Implied contract )

The Sacred Patient-Doctor Relationship – A thing of the past Caring and healing. The Sacred Patient-Doctor Relationship – A thing of the past Caring and healing.

Patient - Doctor Relationship ( Implied contract ) n An implied contract between patient Patient - Doctor Relationship ( Implied contract ) n An implied contract between patient (consumer) and doctor( service provider) for a consideration ( fee ). n Not established : While giving first aid in emergency Pre-employment medical examination Examining a patient under court order Parikh’s Textbook of Medical Jurisprudence Forensic medicine

Requirements of Doctor Patient Relationship Reasonable skill An average degree of skill possessed by 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 n n n Too little time for patients Does not listen Common Patient Complaints n n n Too little time for patients Does not listen Does not explain well Shows no sympathy Neither understands the patient nor his family Harris Poll, 2000 Roper Center Polls, 2000 Hey, DOC !

“Informed” Consent How well do you understand it? “Informed” Consent How well do you understand it?

Informed Consent IMPLIES: Understanding by the patient • Natural history of the disease. • 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 Love’s Short Practice of Surgery, 24 th Edition

Types of consent n Implied : inferred from actions n Express : actively stated Types of consent n Implied : inferred from actions n Express : actively stated n Proxy consent : on behalf of others

Why is Consent Necessary n Willing patient, better outcome n defense against a charge Why is Consent Necessary n Willing patient, better outcome n defense against a charge of assault / battery

When is Consent Necessary Everything in the Doctor - Patient Relationship is CONSENSUAL When is Consent Necessary Everything in the Doctor - Patient Relationship is CONSENSUAL

Express Consent is expected. . n Surgical/Invasive Procedures n Chemotherapy / Radiotherapy n Radiological Express Consent is expected. . n Surgical/Invasive Procedures n Chemotherapy / Radiotherapy n Radiological / Investigational Procedures n Medical Research n Teaching - intimate examination

Competence/Capacity in Informed Consent n Competent Adult ( > 18 yrs ) n In Competence/Capacity in Informed Consent n Competent Adult ( > 18 yrs ) n In case of Minors ( < 12 yrs ) – Parent or legal guardian( Loco Parents ). n Emergency ( the law implies consent ) (Sec. 92. I. P. C. )

Rules Of Consent: n Consent - in the presence of a disinterested third party, Rules Of Consent: n Consent - in the presence of a disinterested third party, e. g. , a nurse. n Consent should not be a blanket permission. n 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. n n The law of Medical Negligence – Dr. H. L. Chulani, 1996.

Why do patients sue? n “Original injury is not enough. ” n Prime concern: Why do patients sue? n “Original injury is not enough. ” n Prime concern: perceived lack of caring n 3 reasons for litigation 1) Altruism – protect others 2) Expose the truth 3) Financial restitution. n Lack of communication. n 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? How does fear of lawsuits alter patient care?

definition Defensive Medicine – the use of costly diagnostic efforts of medical treatments for definition Defensive Medicine – the use of costly diagnostic efforts of medical treatments for the sole purpose of avoiding potential litigation n Litigation has decreased quality of care n More tests than medically needed n More specialist referrals than needed n More invasive procedures than needed n More medicines than needed Fear of Litigation study, Harris Interactive, Apr 2002

Fear of the patient !! Altered patient-doctor relationship n n Potentially adversarial relationship Each Fear of the patient !! Altered patient-doctor relationship n n 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 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 n 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

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

ALLEGATIONS THE SURGEON n Articles left in patient’s body. n Consent not taken prior ALLEGATIONS THE SURGEON n Articles left in patient’s body. n Consent not taken prior to operation. n Operation on wrong side. n Failure in diagnosis or operation. n Not operating in time.

Allegations… ANAESTHESIOLOGIST n Excessive anesthesia n Injury to eyes/skin n Injury from mask/mouth gag Allegations… ANAESTHESIOLOGIST n Excessive anesthesia n Injury to eyes/skin n Injury from mask/mouth gag

Allegations… RADIOLOGIST n Electrical shock & burns n Injuries to vision n Pigmentation n Allegations… RADIOLOGIST n Electrical shock & burns n Injuries to vision n Pigmentation n Loss of hairs

GYNAECOLOGIST n Consent not taken before abortion n Failed tubal ligation n Injury to GYNAECOLOGIST n Consent not taken before abortion n Failed tubal ligation n Injury to uterus n Operation causing sterility

MEASURES PREVENTION AT PERSONAL LEVEL Qualification Communication INTERPERSONAL LEVEL Courteous and polite if any 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 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 n n Forum to discuss acts and cases fought OTHER MEASURES PEOPLE SUPPORT GROUPS n n Forum to discuss acts and cases fought Never talk loose of your colleague MEDICAL ETHICS n Thorough knowledge is a must PROFESSIONAL INDEMNITY n Insurance

DO’S AND DON’TS FOR DOCTORS n HISTORY TAKING Listen attentively DO’S n Maintain privacy DO’S AND DON’TS FOR DOCTORS n HISTORY TAKING Listen attentively DO’S n Maintain privacy n Face patient n Start afresh if distraction n Ask questions intelligently n Give time to the patient

HISTORY TAKING DON’TS n Don’t discriminate. n Don’t assume all what patient says as HISTORY TAKING DON’TS n Don’t discriminate. n Don’t assume all what patient says as correct n Don’t smoke n Don’t look overconfident

EXAMINATION OF PATIENT DO’S n Thoroughly examine the pt. n Oblige again if patient EXAMINATION OF PATIENT DO’S n Thoroughly examine the pt. n Oblige again if patient considers examination incomplete n Review next day if patient is examined hurriedly

EXAMINATION OF PATIENT DON’TS n Don't examine if you are: sick exhausted intoxicated n EXAMINATION OF PATIENT DON’TS n Don't examine if you are: sick exhausted intoxicated n NEVER examine a female patient in the absence of a female nurse or an attendant especially during genital or breast examination

PRESCRIPTION DO’S MENTION: n Qualification/training/experience/designation (Indian Medical Degree Act’ 1916) n Date and timing PRESCRIPTION DO’S MENTION: n Qualification/training/experience/designation (Indian Medical Degree Act’ 1916) n Date and timing of the consultation n Age and sex of patient n Precise history of illness/physical finding n Diagnosis under review if unsettled

PRESCRIPTION DO’S(cont. . ) MENTION : n Refusal for investigation/administration in local language with PRESCRIPTION DO’S(cont. . ) MENTION : n Refusal for investigation/administration in local language with proper witness n H/O drug allergy n Names/dosage/route of administration of drugs clearly with precautions like ac/pc.

PRESCRIPTION DO’S(cont. . ) MENTION : n If patient is pregnant/lactating n Side effect/interaction PRESCRIPTION DO’S(cont. . ) MENTION : n If patient is pregnant/lactating n Side effect/interaction of drug n Emergency treatment in chronic illness n Not to stop drug suddenly if tapering required n If a particular drug/equipment unavailable

MENTION : PRESCRIPTION DO’S(cont. . ) n Reasons for deviation from standard care n MENTION : PRESCRIPTION DO’S(cont. . ) n Reasons for deviation from standard care n Prognosis explained n Where patient should contact if you are unavailable n Review SOS.

PRESCRIPTION DON’ TS § Don’t prescribe : without examination/ banned drugs/ for experimental reasons. PRESCRIPTION DON’ TS § Don’t prescribe : without examination/ banned drugs/ for experimental reasons. § Don’t write : multiple drugs/instructions on separate slip. § Don't allow substitutions.

INVESTIGATIONS DO’S n Analyse cost benefit ratio n Read reports carefully and interpret results INVESTIGATIONS DO’S n Analyse cost benefit ratio n Read reports carefully and interpret results of tests/X -rays properly n Rule out pregnancy before subjecting uterus to X-ray n Consent-invasive invest.

INVESTIGATIONS DON’TS n Never order an investigation unless result is likely to help direct INVESTIGATIONS DON’TS n Never order an investigation unless result is likely to help direct treatment n Don’t allow modern diagnostic test to substitute your clinical judgment n Don’t inform patient has HIV till confirmatory test is done

MANAGEMENT DO’S n Update with latest management by attending CME and conferences n Employ MANAGEMENT DO’S n Update with latest management by attending CME and conferences n Employ qualified assistants n Update facilities and equipment n Obtain legally valid consent before any procedure

MANAGEMENT DO’S(contd. . ) n In case of MTP/sterilization, follow guide lines issued by MANAGEMENT DO’S(contd. . ) n In case of MTP/sterilization, follow guide lines issued by Govt of India n Ensure proper post - operative care n Relieve pain specially in cancer patients

MANAGEMENT DON’TS n Don’t perform procedures in agitated patients eg. broken needle can be MANAGEMENT DON’TS n Don’t perform procedures in agitated patients eg. broken needle can be a cause for law suit n Don’t forget to count swab and instruments when ending operation n Don’t hesitate to take senior’s or colleague help if in trouble n Don’t deny medical care to HIV positive n NEVER AVOID EMERGENCY CALLS

OTHER DO’S n Extend your sympathy to bereaved family n Label a condition as OTHER DO’S n Extend your sympathy to bereaved family n Label a condition as functional only when other causes are ruled out n Issue certificates only when full verification is done

OTHER DON’TS n Don’t refuse leave against medical advise n Don’t withhold information however OTHER DON’TS n Don’t refuse leave against medical advise n Don’t withhold information however harsh and difficult(sensitive communication) n Don’t refuse patient’s right to examine and receive an explanation about your bills

Outcome: judgment and awards Outcome: judgment and awards

Award designated Verdict for plaintiff 19% Court 7% verdict 81% Case to 8 -13% Award designated Verdict for plaintiff 19% Court 7% verdict 81% Case to 8 -13% trial 93% “Litigation lottery” and frivolous law suits? Claim 1. 5% filed 92 -87% 98. 5% Patient injured Hyatt, et al, “A study of medical injury and med mal: an overview, ” NEJM, 1989

Doctor’s Indemnity Why do doctors need insurance anyway? Peace of mind Doctor’s Indemnity Why do doctors need insurance anyway? Peace of mind

Insurance does not cover n Any Criminal act n Services rendered while intoxicated n Insurance does not cover n Any Criminal act n Services rendered while intoxicated n Any procedure under GA outside hospital n Use of miracle drugs n Cosmetic surgery

Other Problems With Insurance n High premiums n Do not pay whole of the Other Problems With Insurance n High premiums n Do not pay whole of the damages n Lot of running around n Defense lawyer in the insurance co. panel lacks adequate medico-legal knowledge n Patients are encouraged to go in for litigation

The Best Insurance Policy THE 3 C’s: CARE CONCERN CONSIDERATION Faith is the only The 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)