Dr Nikhil Datar MD DNB FCPS FICOG LLB DGO DHA Gyneaecologist, Medico-legal Expert & Health Rights Activist Chairman Medico-legal cell Association of Medical Consultants National Coordinator Medico-legal cell FOGSI. Head Medico-legal wing Kay Legal Advocates.

 Related to establishment  Income tax Act.. Bio medical waste Disposal.. DC rules  Related to medical profession  Criminal law  Civil / Consumer law  Professional ethics  Human rights  Specific laws: MTP, PCPNDT,Organ Donation  Future Laws: ART Bill, Euthanasia, MTP Act

 Criminal law, police procedures  Civil law and procedures  Law : Negligence  Law : Consent  Laws in making :  MTP Act ( Niketa Mehta)  Euthanesia ( Aruna Shanbhag ) tips

 Consultant Gynaecologist at Nanawati hospital Mumbai  Director : Datar wellness group ( which runs two nursing homes in western suburbs of Mumbai)  PG teacher at R N Cooper Municipal Hospital  Recipient : Commonwealth Fellowship award : Worked with WHO on patient safety & reducing medical errors  Recipient: IFHHRO fellowship American Austrian foundation  Fought famous case along with his patient Niketa Mehta challenging the MTP Act Govt of India  Medico-legal consultant: Kay Legal Advocates

Nikhil Datar

 Police ( criminal law)  Advocate ( civil law)  Medical council ( Professional misconduct)  Media ( TRP law)  Ransacking the hospital / assaulting the staff

Dr Nikhil D. Datar 1. Can I give a DC? Is PM mandatory? 2. Should I inform police? 3. What to do if I get a “friendly call” from PM room? 4. Will the police arrest me?

Dr Nikhil D. Datar 5 What will happen to the reputation? 6 What will the consumer court decide? 7 What is my indemnity cover? 8 Will relatives ransack the hospital?

 Prevention of violence  Damage and loss of property

 Offence cognizable and non-bailable  Imprisonment up to 3 years and fine up to Rs  Compensation twice the amount of damage caused

Actus Non Facit REUM,NIsi Mens Sit Rea Lord Macaulay (1833)

Dr Nikhil D. Datar  Offences against public health (chp XIV)  Offences against human body - affecting life (s 299-s 311) - affecting unborn child (s ) - hurt (s ) - wrongful restraint (s ) - sexual offences (s )  Forgery (s 463)  Defamation (s )  Fraudulent use of weights (chp XIII)

Dr Nikhil D. Datar  Lawful homicide  Unlawful homicide - Culpable homicide (s 299) - Murder Can a doctor be charged for culpable homicide ? Mahadev Prasad Kaushik Vs State of UP (SC) - Rash & Negligent Act (S 304 A)

Dr Nikhil D. Datar

If he knows the cause of death And not otherwise not otherwise

Dr Nikhil D. Datar  When cause of death is not known  When cause of death is known but………….

Dr Nikhil D. Datar  Death linked with abortion  Death on operation table or post op 24 hours  Death related to medical procedure

Dr Nikhil D. Datar  Death related to accidents or violence  All deaths related to tubal sterilizations (PM mandatory)  When there is allegation of medical mis- management (source:J.K.Mason.Edition III)

Dr Nikhil D. Datar  This is a wrong equation

Dr Nikhil D. Datar  Informing the police  “Panchnama”  Handing over the papers

Dr Nikhil D. Datar  PM report  Opinion of police surgeon  FIR  Arrest

Dr Nikhil D. Datar It is a cognizable and bailable offence

Dr Nikhil D. Datar  Surgery without consent  Surgery on wrong patient or wrong organ  Leaving mop or instrument inside  Transfusing wrong blood  Performing criminal abortion (source:Medical Negligence & Compensation Edition II )

Dr Nikhil D. Datar  Before surgery 1. Check the consent 2. Confirm the identity of patient and nature of surgery 3. Use the Checklist as a matter of “ritual” 4. Check the expiry of drugs (S ) 5. Insist that the anaesthetist talks and examines the patient before starting 6. Use the “life saver board”

Dr Nikhil D. Datar

 “Presumption of innocence”  Burden of proof  Degree of evidence  Prosecution has to prove the need of penal remedy.

Police ( criminal law) Notice of advocate ( civil law) Notice from medical council ( medical council) Media ( TRP law)

 Complaint  Written statement  Rejoinder  Sur rejoinder

 Laws and rules  Text books  Expert Evidence  Guidelines from professional bodies Nikhil Datar

 Consent  Negligence

Violation of “Right in Rem” Duty imposed by law Duty independent of consent Violation of “Right in Personum” Duty imposed by terms of contract Consent important Dr Nikhil Datar

 Damages unliquidated  Limitation : from the date when damage is suffered  Damages well defined  Limitation: from the date of breach of contract Dr Nikhil Datar

Law of torts  Competent to consent  Capacity to consent Dr Nikhil Datar

 False Imprisonment  Assault & Battery  Mayhem

1. Fraud 2. Misrepresentation 3. Undue influence 4. Non voluntary 5. Not an “ informed consent ” Dr Nikhil Datar

 Samira Kohli Vs Dr Prabha Manchanda (SC)

 Capacity & competency to consent  Voluntary  On the basis of adequate information

 Nature & procedure, its purpose, benefits and effects  Alternatives available  Outline of substantial risks ( 10%)  No need to explain remote risks ( 1-2%)  Consequences of refusing the prescribed treatment  Boalm’s test shall prevail

 Consent for diagnostic procedure can’t be considered valid for therapeutic procedure even if there is physical or financial benefit  The exception to the above rule is “ life saving conditions”  Comprehensive consent can be taken before hand

 Breech of duty  Doing or not doing some thing which a reasonable and prudent man would not do or do.

 Legal duty must exist  Duty can be independent of contract  Damage should be caused (causa causans)  Act must be below the “Standard of reasonable care” Dr Nikhil Datar

 Boalm Vs Frien Health authority “A man need not possess the highest expert skill; it is well established law that it is sufficient if he exercises the ordinary skill of an ordinarily competent man exercising that particular art." (Charlesworth & Percy, ibid, Para 8.02)

 Criminal negligence  Civil negligence  Mistake  Error  Misfortune/ “Act of God”

 Jacob Mathew Vs State of Punjab

 Degree of damage Vs degree of negligence  Mens rea ( reckless state of mind though not intention to cause harm) for criminal negligence  Conviction beyond doubt Vs Preponderance of probability  Section 304 A to be read should be read as qualified by the word “ gross”  Lord Diplock in R Vs Lawrence: “Rashness of such a degree that injury was most likely imminent”

 Government to form rules and guidelines  The IO.. obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice after applying Bolam's test.  A doctor accused of rashness or negligence, may not be arrested in a routine manner (simply because a charge has been leveled against him). Unless his arrest is necessary. Are doctors capable of handling this?

 Jacob Mathew vs State of Punjab  Martin D souza vs Mohd Isfaq  V krishnarao vs Nikhil super speciality Hospital

MTP Act: Dr Nikhil Datar VS Govt of India Euthanesia: Pinky Virani Vs Govt of India

My patient Niketa Haresh Mehta 24 weeks pregnant.. Found two major heart anomalies of the fetus.. Opinions of 6 reputed doctors ( cardiologists and pediatricians)… “substandard quality of life and mortality” Patient wanted termination of pregnancy. I refused “Illegal termination” and patient refused to change the doctor thus I became the principal petitioner and invoked the writ jurisdiction

Section3 (2) (b) : -There is substantial risk that if the child were born, it would suffer from such physical or mental abnormalities as to be seriously handicapped. -The continuance of the pregnancy would involve a risk to the life of the pregnant woman or of grave injury to her physical or mental health (This section allows the termination only till 20 weeks of pregnancy.) Beyond 20 weeks, termination is allowed : if immediately necessary to save the life of the pregnant woman.

 The word “substantial risk” is very vague... it is open to different interpretation by courts of law and may lead to endless trouble for doctor concerned. Efforts should have been made to better define the risks.  --- Dr H N Shivpuri (1967)

Significant improvement in diagnostics as compared to therapeutics. The doctors can only give the statistical prognosis but not individualistic prognosis. Late termination has medically became very safe. Every case will be different and decisions intensely personal based on the values, beliefs of the person.

 When does the life begin?  How to choose between sanctity & quality of life?  How to determine the “best interest” of the foetus who can’t speak or can’t be even examined?  How does one see this in the light of poor country & self funded health care?

The Nuffield Council on Bioethics is funded jointly by the Medical Research Council, the Nuffield Foundation and the Wellcome Trust. Health economist, disability commissioner, anthropologist, Reputed doctors from fields of Obstetrics, neonatology, Lawyers, ethicist, Rights activists.

 We regard the moment of birth, which is straightforward to identify, and usually represents a significant threshold in potential viability, as the significant moral and legal point of transition for judgements about preserving life. --- Working party

 When the baby’s life results in a level of irremediable suffering, there is no ethical obligation to act in order to preserve that life. - Working party

It is immoral that the pregnant woman acts wrongly in harming her future child by acting neglectfully or in a manner that is wilfully harmful, as happens occasionally, It would be wrong to force a woman to behave rightly by submitting to medical or surgical interventions to benefit a foetus against her will.

 It is in the “ best interest “ of the fetus to survive or not, to avoid “ intolerable life” and best quality of life.  It is reasonable to consider parents interests socio economic issues as well.

FIGO Committee for The Study of Ethical Aspects of Human Reproduction and Women’s Health “The Committee agreed that a woman carrying a severely malformed fetus had the ethical right to have her pregnancy terminated. The qualification ‘severe’ is used in this context to indicate malformations that are either potentially lethal or whose nature is such that even with medical treatment they are likely, in the view of the parents and their medical advisors, to result in unacceptable mental and/or physical disability.”

 Hon’ble Bombay High court refused the permission.  I am in appeal at the SC.  Union Health minister appointed a committee.

 Facts of the case  Court recorded the reasons for going into the issue though it was not amounting to violation of fundamental rights  No to active euthanesia  Yes to passive euthanasia provided:  next keen approaches  Doctors panel approves  Two judge panel of the HC allows

 legal validity of “ Do not resuscitate”  Leaving will

As it is, humans are imperfect. Law and medicine, both deal with human beings & are imperfect sciences. The set of another human beings ( doctors & judges) administer these imperfect sciences. Thus it is perfect that law related to medicine will be more imperfect and admixed with complex issues.

Nikhil Datar