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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

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
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
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
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
Consequences:
  • Police ( criminal law)
  • Advocate ( civil law)
  • Medical council ( Professional misconduct)
  • Media ( TRP law)
  • Ransacking the hospital / assaulting the staff
our worries
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 worries1
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
Maharashtra medicare service persons & institutions 0rdinance
  • Prevention of violence
  • Damage and loss of property
penalty
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
Criminal law for doctors

Lord Macaulay (1833)

Actus Non Facit REUM,NIsi Mens Sit Rea

healthcare indian penal code
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
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

a doctor can give dc
A doctor can give DC:

If he knows the cause of death

And

not otherwise

Dr Nikhil D. Datar

inform the police
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
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 police1
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
Reporting the death to police=Performing post mortem
  • This is a wrong equation

Dr Nikhil D. Datar

interaction with the police
Interaction with the Police
  • Informing the police
  • “Panchnama”
  • Handing over the papers

Dr Nikhil D. Datar

police procedure
POLICE PROCEDURE
  • PM report
  • Opinion of police surgeon
  • FIR
  • Arrest

Dr Nikhil D. Datar

slide22

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
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
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
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

consequences1
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
Civil procedure code & procedure in consumer courts
  • Complaint
  • Written statement
  • Rejoinder
  • Sur rejoinder
proving standard of care
Proving standard of care
  • Laws and rules
  • Text books
  • Expert Evidence
  • Guidelines from professional bodies

Nikhil Datar

tort contract
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 contract1
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
Consent : general principles

Law of torts

  • Competent to consent
  • Capacity to consent
no consent
No consent
  • False Imprisonment
  • Assault & Battery
  • Mayhem
consent no good
Consent: No good
  • Fraud
  • Misrepresentation
  • Undue influence
  • Non voluntary
  • Not an “ informed consent”
law on consent
Law on consent
  • Samira Kohli Vs Dr Prabha Manchanda (SC)
doctrine of real valid consent
Doctrine of “ Real & valid consent”
  • Capacity & competency to consent
  • Voluntary
  • On the basis of adequate information
how much is adequate
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
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
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
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
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
Grades of adverse events
  • Criminal negligence
  • Civil negligence
  • Mistake
  • Error
  • Misfortune/ “Act of God”
criminal vs civil negligence
Criminal vs civil negligence
  • Jacob Mathew Vs State of Punjab
criminal vs civil negligence1
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
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
Shifting pendulum..
  • Jacob Mathew vs State of Punjab
  • Martin D souza vs Mohd Isfaq
  • V krishnarao vs Nikhil super speciality Hospital
future laws

Future laws

MTP Act: Dr Nikhil Datar VS Govt of India

Euthanesia: Pinky Virani Vs Govt of India

facts of my case
Facts of my case
  • 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
mtp act
MTP Act

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.

shantilal shah committee report
Shantilal Shah Committee report
  • 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)
medical facts
Medical facts
  • 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.
decision making ethics morality law
Decision making: Ethics, morality & law
  • 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?
nuffield council on bioethics critical care decisions in fetal and neonatal medicine ethical issues
Nuffield Council on BioethicsCritical care decisions in fetal and neonatal medicine: Ethical issues

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.

balancing rights right
Balancing rights .. right
  • 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

balancing rights right1
Balancing rights … right
  • 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

balancing rights right2
Balancing rights… right

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.

balancing rights right3
Balancing rights … right
  • 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.
international federation of obstetrics gynaecology
International Federation of Obstetrics & Gynaecology
  • 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.”

current status
Current status
  • Hon’ble Bombay High court refused the permission.
  • I am in appeal at the SC.
  • Union Health minister appointed a committee.
aruna shanbhag
ArunaSHanbhag
  • 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
unanswered questions
Unanswered questions:
  • legal validity of “ Do not resuscitate”
  • Leaving will
slide65

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.

slide66

thank you

Nikhil Datar