CONSUMER PROTECTION ACT FOR MEDICAL PROFESSION IN INDIA

1. 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)

2. Time line Guidelines for good medical practice across the ages : The Code of Hammurabi ( 2000 B.C. ) Park’s textbook of PSM,16th edition

3. 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 kaisyngraphe)…” Park’s textbook of PSM,16th edition

4. Time line….. • 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

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

6. 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

7. 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

8. WHERE TO GO ? Consumer Dispute Forum Civil Court Criminal Court Medical Council

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

10. 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

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

12. Consumer Disputes Redressal AgenciesDISTRICT 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

13. Consumer Disputes Redressal AgenciesSTATE 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

14. Consumer Disputes Redressal AgenciesNATIONAL 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

15. 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.

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

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

18. Proof of Negligence 4 D’s • The essentials of negligence are four "D"s: • There was a Duty towards patients; • There was Deficiency in duty • This Directly resulted in (causa 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  

19. 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.

20. 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.

21. A patient’s journey through the realm of medical malpractice Qualityofcare Commitment of medical error A Doctor’s Defense Outcome: judgment and awards

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

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

24. 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 Parikh’s Textbook of Medical Jurisprudence Forensic medicine

25. 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

26. Too little time for patients Does not listen Does not explain well Shows no sympathy Neither understands the patient nor his family Common Patient Complaints Hey, DOC! Harris Poll, 2000 Roper Center Polls, 2000

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

28. 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, 24th Edition

29. Types of consent • Implied : inferred from actions • Express : actively stated • Proxy consent : on behalf of others

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

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

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

33. 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.)

34. 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.

35. Why do patients sue? • “Original injury is not enough.” • Prime concern: perceived lack of caring • 3 reasons for litigation • Altruism – protect others • Expose the truth • 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

36. How does fear of lawsuits alter patient care?

37. Defensive Medicine – the use of costly diagnostic efforts of medical treatments for the sole purpose of avoiding potential litigation definition • 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

38. 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

39. 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

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

41. 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.

42. Allegations… ANAESTHESIOLOGIST • Excessive anesthesia • Injury to eyes/skin • Injury from mask/mouth gag

43. Allegations… RADIOLOGIST • Electrical shock & burns • Injuries to vision • Pigmentation • Loss of hairs

44. GYNAECOLOGIST • Consent not taken before abortion • Failed tubal ligation • Injury to uterus • Operation causing sterility

45. 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

46. PREVENTION AT PRACTICE MEDICAL Reasonable skill and care SOCIAL Exhibit skill to patient: body language LEGAL • Document in legible handwriting • Record of failure

47. 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

48. DO’S AND DON’TS FOR DOCTORSHISTORY TAKINGDO’S • Listen attentively • Maintain privacy • Face patient • Start afresh if distraction • Ask questions intelligently • Give time to the patient

49. Don’t discriminate. Don’t assume all what patient says as correct Don’t smoke Don’t look overconfident HISTORY TAKINGDON’TS

50. EXAMINATION OF PATIENTDO’S • Thoroughly examine the pt. • Oblige again if patient considers examination incomplete • Review next day if patient is examined hurriedly