Medicolegal Aspect

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Medicolegal Aspect
Blood is a consumable item considered as drug under schedule 'C' of Drugs and Cosmetics Rule of
Indian Pharmacopia. And otherpharmacopias of the world viz. Brftish Pharmacopia, United States
Pharmacopia, FDA of USA also treats whole human blood and its products under the same category. In
India requirement of blood bank, component separation etc. dealt under section 'F of the said rule (Drug
and Cosmetic Act).Under Rule18 'C', collection of blood is considered as a manufacturing process of
blood transfusion and requires to be processed/manufacturedunder valid licence granted by an authorised
body, Drug Controllerof India, consists of a representative from state, representative from Centre (Ministry
of Health Affairs) and an expert. The licence is granted for a limited period and renewal is subject to
inspection after the previous date of licence is over. As such the production manufacture, processing,
transfusion of blood and blood product has a medicolegal aspect which a transfusion practitioner ought
to know and is briefly discussed below in Indian context.
A rei vew of world literature on history ofblood transfusion finds mentionof medicolegal controversy.
arising out of transfusion (animal to man) of a luetic patient conducted by Jean Dennis (physician to
King Louis XV of France). The patient died after three successive transfusion which occurred in and
around1667-68. The wife of the dead patient lodged a complaint against the physician for causing death
.due to transfusion. After a long trial though Dennis was exonerated, a restriction was imposed on practice
of transfusion on human being which was made subject to sanction from the Faculty of Medicine of
Paris.
The practice was thus discontinued but later on revived by James Blundell in and around 1817 to
1820 after a gap of about 150 years. Blundell first established the species bar through his experiments
and started the homologus transfusion (man to man). The later development of antigen and antibody etc.
made the transfusion practice safer. But even then and till now, the transfusion practice in its present
form is always considered hazardous and little negligence o~ slackness may bring forth disastrous
consequence for the patient which may be followed up by legal procedure or penalty on the practitioner.
A practitioner of transfusion, thus should be aw~e
of the type of penalties, he may have to face.
Hazard of transfusion and other related practice that may end up with imposition of penalty.
A. Mismatched transfusion that finally cause death to the recipient of such transfusion whether it
is whole human blood or its product.
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Medicolegal Aspect
469
B. Transfusion transmitted disease (ITO) contacted by the recipient as a result of such transfusion
subject to establishment by prosecution that the disease contacted is only and only as a result of
transfusion.
c. Unlicenced .production of blood and blood product, substandard labeJling or mislabelling of the
blood or component, production of whole human blood or component not in accordance to the
condition specified.
A brief discussion on each A, Band C
Mismatched transfusion (described elsewhere in this book, Chapter fO.5) may produce immediate or
delayed signs and symptoms. If not properly treated it may eventually lead to fatality and death of the
victim. To establish that death is due to acute haemolytic reaction resulting from mismatched 'transfusion
is difficult. The postmortem finding are only suggestive and not clearcut or definitive. More commonly
the recipient of transfusion are patients (surgical or medical) or victims of accidents and as such the
findings are also likely to be clouded by pathophysiology ofdisease and/or drug effect. So before arriving
at any conclusion that death is due to mismatched one must carefully consider all the factors mentioned
above.
Autopsy on a death due to mismatched transfusion or transfusion related death is most likely to
reveal.
(a) In acute intravascular haemolytic reactions, .haemogloblnuric nephrosis is seen. The tubules
will show acute necrosis 'and casts of haemoglobin.
(b) Lungs will be oedamatus in cases of circulatory overload.
(c) Air in the right ventricle indicates death due to "air embolism".
Additional findings associated
1. Phlebotomy. wound or mark through which blood/component was transfused, their might be
local oedema or discolouration.
2. Purpuric spots over the skin which may be generalised.
A proved case of death due to mismatched transfusion is a cognizable offence and can be tried in the
court of law under provision of Indian Penal Code Act. The Band C comes under the purview of Indian
Drugs and Cosmetics Act, 1940.Theoffences and penalties thereunder concerning blood bank is described
below.
1. Manufacture for sale or selling whole human blood I.P. without a valid licence as required
under clause (C) of Section 18 is considered an offence.
Penalty : Imprisonment for a temi which shall not be less than one year but which may extend
to three years and with fine which shall. not be less than five thousand rupees under Section 2
(b) (ii) or the act.
2. Manufacture for sale or selling whole human blood I.P. contaminated with Human
Immunodeficiency Virus (HIV) or Hepatitis B virus or not sterile is a substandard drug within
meaning of Section ]6(i)(a) f the act - an offence.
Penalty: An imprisonment for a term which shall not be less than five years but which may
extend to a term of life and with fine which shall not be less than ten thousand rupees under .

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470
Blood Banking and Transfusion
Section27(a).BecausethewholehumanbloodI.P. contaminatedwithhumanimmunodeficiency
virus or HepatitisB virus likely to cause death or is likely to cause such harm shouldamountto
grevious hurt within the meaning of the section 320 IPC.
.
3. Manufactureof the wholehumanbloodI.P. for sale or sellingwhichis not labelledin prescribed
manner is misbranded within the meaning of the section 17(b) of the act, is considered an
offence.
Penalty :.Imprisonrnent of a term which shall not be less than one year but whichmay extend to
2 years and with fine under Section 27(d) of the act.
4. Manufactureof wholehumanblood I.P. for scale or sellingnot in accordancewith the condition
of a licence issued for such purpose - an offence.
Penalty: Imprisonmentfor a term which shall not be less than one year but which may extend
to 2 years and with fine under Section 27(d) of the act.
Please note that in offence No. (2) HIV etc. is included after its discovery.
The other relatedmedicolegalaspectis the applicationof bloodgroupserologyin Forensicmedicine
namely in determinationof disputed paternityand identificationof blood stains and differentiation from
other body fluids.Theconceptis wellknownandhighlightedin othertextbookson bloodgroupserology.
A transfusionistmayoccasionallybe called in for a second opinionor primary opinion in abscenceof a
forensic expert In such cases transfusionistis advisedto follow all proceduralformalities before giving
his expert opinion.
Books and' journals recommended for further reading
I. The Essentials ofForensic Medicine and Toxicology, K.S. Narayan Reddy, Thirteenth edition, 1992, Publisher
K. Suguma Debi, Hyderabad-500036, India.
2. Textbook ofBlood Banking Science, Chester M. Zmijudski and Walter Ee . Haseler; 1982 Edition, Appleton-
Century Crofts.