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Legal aspects of healthcare. 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.
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Legal aspects of healthcare 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.
Health care & law • 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
Shall address • Criminal law, police procedures • Civil law and procedures • Law : Negligence • Law : Consent • Laws in making : • MTP Act ( Niketa Mehta) • Euthanesia ( Aruna Shanbhag ) tips
My take.. • 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
Consequences: • Police ( criminal law) • Advocate ( civil law) • Medical council ( Professional misconduct) • Media ( TRP law) • Ransacking the hospital / assaulting the staff
Our worries: • Can I give a DC? Is PM mandatory? • Should I inform police? • What to do if I get a “friendly call” from PM room? • Will the police arrest me? Dr Nikhil D. Datar
Our worries: • What will happen to the reputation? • What will the consumer court decide? • What is my indemnity cover? • Will relatives ransack the hospital? Dr Nikhil D. Datar
Maharashtra medicare service persons & institutions 0rdinance • Prevention of violence • Damage and loss of property
penalty • Offence cognizable and non-bailable • Imprisonment up to 3 years and fine up to 50000 Rs • Compensation twice the amount of damage caused
Criminal law for doctors Lord Macaulay (1833) Actus Non Facit REUM,NIsi Mens Sit Rea
HEALTHCARE & Indian penal code • Offences against public health (chp XIV) • Offences against human body - affecting life (s 299-s 311) - affecting unborn child (s 312-318) - hurt (s319-338) - wrongful restraint (s 339-348) - sexual offences (s375-377) • Forgery (s 463) • Defamation (s499-500) • Fraudulent use of weights (chp XIII) Dr Nikhil D. Datar
Homicide • 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
Death Certificate:To Be(given) OR Not To Be(given)!! Dr Nikhil D. Datar
A doctor can give DC: If he knows the cause of death And not otherwise Dr Nikhil D. Datar
Inform the police: • When cause of death is not known • When cause of death is known but…………. Dr Nikhil D. Datar
When to inform police • Death linked with abortion • Death on operation table or post op 24 hours • Death related to medical procedure Dr Nikhil D. Datar
When to inform police: • 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
Reporting the death to police=Performing post mortem • This is a wrong equation Dr Nikhil D. Datar
Interaction with the Police • Informing the police • “Panchnama” • Handing over the papers Dr Nikhil D. Datar
POLICE PROCEDURE • PM report • Opinion of police surgeon • FIR • Arrest Dr Nikhil D. Datar
Section 304 A:Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide shall be punished with imprisonment for two years , or with fine or with both. It is a cognizable and bailable offence Dr Nikhil D. Datar
Acts held “negligent” • 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
Preventing criminal negligence • Before surgery • Check the consent • Confirm the identity of patient and nature of surgery • Use the Checklist as a matter of “ritual” • Check the expiry of drugs (S 273-276) • Insist that the anaesthetist talks and examines the patient before starting • Use the “life saver board” Dr Nikhil D. Datar
In the Criminal court: • “Presumption of innocence” • Burden of proof • Degree of evidence • Prosecution has to prove the need of penal remedy. Dr Nikhil D. Datar
Consequences: • Police ( criminal law) • Notice of advocate ( civil law) • Notice from medical council ( medical council) • Media ( TRP law)
Civil procedure code & procedure in consumer courts • Complaint • Written statement • Rejoinder • Sur rejoinder
Proving standard of care • Laws and rules • Text books • Expert Evidence • Guidelines from professional bodies Nikhil Datar
Out of court settlement:“Settle” it……… officially! Nikhil Datar
Doctor Patient Relationship • Consent • Negligence
Tort Contract • 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
Tort Contract • Damages unliquidated • Limitation : from the date when damage is suffered • Damages well defined • Limitation: from the date of breach of contract
Consent : general principles Law of torts • Competent to consent • Capacity to consent
No consent • False Imprisonment • Assault & Battery • Mayhem
Consent: No good • Fraud • Misrepresentation • Undue influence • Non voluntary • Not an “ informed consent”
Law on consent • Samira Kohli Vs Dr Prabha Manchanda (SC)
Doctrine of “ Real & valid consent” • Capacity & competency to consent • Voluntary • On the basis of adequate information
How much is “ adequate”? • 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
Can there be a blanket consent? • 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
Law of medical Negligence • Breech of duty • Doing or not doing some thing which a reasonable and prudent man would not do or do.
Negligence: Ingredients • 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”
Standard of Reasonable care • 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)
Grades of adverse events • Criminal negligence • Civil negligence • Mistake • Error • Misfortune/ “Act of God”
Criminal vs civil negligence • Jacob Mathew Vs State of Punjab
Criminal vs civil negligence • 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”
Suggested mechanism • 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?
Shifting pendulum.. • Jacob Mathew vs State of Punjab • Martin D souza vs Mohd Isfaq • V krishnarao vs Nikhil super speciality Hospital
Future laws MTP Act: Dr Nikhil Datar VS Govt of India Euthanesia: Pinky Virani Vs Govt of India