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https://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0%2F0%2FCC%2F14%2F2010&dtofhearing=2023-06-16
Pronounced
on: 16th June 2023
ORDER
The Judgment begins
with the Following Para :
In our country, mushrooming of ART centres has led to incorrect
treatment of the innocent infertile couples. The specialist requires a
correct knowledge about the physiology of ovulation as well as
reproductive gynaecology. Routine gynaecologists without having in-depth
knowledge, using incorrect protocols may be harmful. One must realise
that the infertility patients are stressed both emotionally as well as
financially. The instant complaint involves many burning issues like
medical ethics, unfair practices and misleading advertisement.
Facts in
Short :
1.
It all started September 2008, the complainant
- couple Priyanka Tandon & Dinesh Tandon on advice of Dr. Archana
Dhawan Bajaj (OP-5), approached Bhatia Global Hospital and Endosurgery
Institute (for short ‘Bhatia Hospital’-OP-1) at New Delhi for Intra-Cytoplasmic
Sperm injection (ICSI). The OP-4 Dr. Indu Bhatia and OP-5 have assured
the couple about the success of ICSI.
2.
Accordingly, on 13.10.2008, the couple got admitted in the OP-1 hospital
and first step of ICSI procedure was completed. Thereafter, on
15.10.2008, embryo transfer was done in Ms Priyanka. Her pregnancy was
confirmed on 04.11.2008. She gave birth to female twins on
15.06.2009. The blood group of one of the twins revealed AB(+),
which was not a possible outcome as the blood group of the parents
was B (+) and O- Negative the mother and father respectively.
Therefore, on 11.12.2009, Paternity test (DNA profile) was conducted at
Centre for Cellular and Molecular Biology (“CCMB”) Hyderabad. It
revealed that the Complainant No. 2 was not the biological father of the
twins. Being aggrieved the couple filed the instant Consumer Complaint
to claim Rs. 2 crores as compensation for the alleged negligence and deficiency
in service which created emotional stress, family discord, fear of
genetically inherited diseases etc.
3.
Defense of Hospital and Doctors – Passing the buck :
Hospital denied its involvement or
liability and submitted that is not liable,
but the Opponent Doctors i.e. Dr. Archana and Dr. Indira who were alleged
to be the personal Doctors of the patient.
The Hospital has
provided the space/accommodation for her I.V.F. Laboratory on usual
consultancy terms of 75:25 ratio (75% to the Consultant & 25% to the
Hospital). The I.V.F. laboratory set up by OP- 5 was absolutely separate
& distinct from the hospital laboratory. The I.V.F. laboratory had been
maintained & monitored by OP- 5 at her own costs. The
Hospital & its directors are nowhere involved in any consultant's way
of treating the patient and it is only the consultant who administers the
treatment to the patient independently, without any knowledge, involvement
of the hospital or its Directors.
Defense of the
Doctor : Dr. Indu Bhatia (Opp. No.4) :
a.
The OP-4 Dr.
Indu Bhatia submitted that the Complainants’ treatment was duly performed
by Dr. Archana Dhawan Bajaj (OP-5) and Dr. Indira Ganeshan (OP-6) who are
very competent in their fields and have specialization in the field.
The laboratory, operation theatre etc. for I.V.F. had been set
up by the OP-5 at her own costs & expenses and remained under her
lock and key .
b.
The entire
set-up including the salary of technicians, anaesthetist, and embryologist
and nursing staff was done by OP-5. The staff of I.V.F. laboratory
was not on the pay roll of the hospital.
Defense of the
Doctor : Dr. Archana Bajaj (Opp. No.5) :
a.
The OP-5
submitted that that Dr. Indu Bhatia (OP-4) the Director of Global Fertility
Centre in Bhatia Global Hospital was the sole in charge of the IVF lab/OT.
b.
All
activities/procedures etc. were carried on after her approval/consent. She
further submitted that as requested by the hospital management,
she provide her services as an IVF specialist to the patients on
normal consultancy terms of 50:50 ratio (50% Consultant, 50% Hospital).
c.
The
understanding with hospital that all the infrastructure like the
laboratory, Operation Theatre etc. for the IVF procedure would be set up by
the OP-1 hospital, and all expenses of the assisting Doctors like the
Anesthetist Doctor, Ultrasonologist,
nursing staff, etc. would be maintained and monitored by the hospital at
their own cost.
d.
The billing of
the patients would be done by the hospital under its name, and the hospital
administration would be responsible for maintaining documentation of the
admission, consent, patient history and discharge of the patient.
e.
The OP-5 was
only a visiting consultant at OP-1. The IVF laboratory was established and
maintained by OP-1. Her role was limited to extracting the oocytes (eggs)
from the female patient. In the instant case the extracted the oocytes were
handed over to the embryologist.
f.
The semen sample of the male (which in
this case was received by OP-6) was then handed over to the embryologist,
who then washed, cleaned and prepared. The washed sperm samples were
labelled under the supervision of OP -6. The oocytes and sperm samples for
incubation were then left in the incubator for a period of approximately 4
hours. During this period, the lab remain locked and the keys
were handed over the staff of OP -1. Therefore, at no point of time, the
keys of the IVF Lab were in custody of OP-5 either before or after
the IVF procedure. The case sheet, along with the consent form were under
the custody of the Hospital.
It was alleged that the Semen sample was mixed by the
relative of the complainant who was handed over the semen sample !
g.
The OP-5 further
confirmed the mixing could have happened at two stages i.e. at the stage of
collection of semen or during storage for four hours before insemination. In the instant case, at the time of collection of semen sample, on
the insistence of the Complainants, one Mr. Sunil Gambhir, who was a close
relative of the Complainants, was present in the I.V.F. laboratory and also
in semen collection room. The sample of semen was then handed over to OP- 6
by Mr. Sunil Gambhir, therefore there was every possibility that the
alleged mixing was done by Mr. Sunil Gambhir with the knowledge of
Complainant no. 2. Thus, the complainants were in collusion &
connivance with Dr. Indira Ganeshan (OP-6) with dishonest and malafide
intention were blackmailing the OP-1 to 5 in a pre-planned and syndicated
manner.
Defense of Dr. Praveen Bhatia – Op.No.6 (Director of
the Hospital)
a. The OP-6
submitted that the OP-5 agreed to perform ICSI on Priyanka at OP-1
hospital, as the sperm count of Complainant no.2 was very low. The OP-4 was
a Gynaecologist and Director, at the OP-1 hospital. The OP-6 further
submitted that, she was not on the panel of the hospital nor engaged
to conduct the procedure as she did not possess professional
expertise. She was implicated though the procedure was performed by OP-5
with the active involvement of OP No.2- 4.
b. The OP.6 categorically denied that she handed over
the sperms to OP-5 or any of her teammates. The ICSI was performed by OP-5
but she was mis-stating the sequence of events.
Held :
1. The NCDRC
after going through the arguments and documents on record, first referred
to the standard text books on
‘Immunohematology’ for deciding the blood group and the genetic transmission of possible blood
groups from parents to the baby is reproduced in the following table:
|
Blood Groups of Parents
|
Possible Blood group of baby
|
Completely Impossible
|
|
A & A
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A, O
|
B, AB
|
|
A & B
|
A, B, AB, O
|
None
|
|
A & AB
|
A, B, AB
|
O
|
|
A & O
|
A, O
|
B, AB
|
|
B & B
|
B, O
|
A, AB
|
|
B & AB
|
A, B, AB
|
O
|
|
B & O
|
B, O
|
A, AB
|
|
AB & AB
|
A, B, AB
|
O
|
|
AB & O
|
A, B
|
A B, O
|
|
O & O
|
O
|
A, B, AB
|
2. Admittedly,
the blood groups of twins differ from their parents. One of the twins was
AB+ whereas the Complainant No.1 -Mother was B+ and Complainant No.2
-Father was O-. Thus, it is clear that due to the negligence of OPs
during ICSI or IVF procedure, such disaster occurred.
3. The NCDRD
referred to the DNA report dated 09/12/2009 which stated
“It is therefore concluded that Mrs. Priyanka Tandon is the
biological mother of Baby 1 of Mrs. Priyanka Tandon and Baby 2 of Mrs.
Priyanka Tandon but Mr. Dinesh Tandon cannot be the biological father of
the Baby 1 of Mrs. Priyanka Tandon and Baby 2 of Mrs. Priyanka Tandon.”
The DNA
Report was tried to be disapproved by the Opponents, but in vain.
4. it was
observed that this was not the first case of ART for the couple in year
2006, for 1st pregnancy, the couple underwent successful
ICSI at Batra Hospital and gave birth to their first daughter. It is
pertinent to note that the sperm count of the Complainant No. 2 was very
low and therefore the procedure other than ICSI would not be successful for
the instant couple. It is pertinent to note that word ‘ICSI’ was
clearly mentioned in the prescriptions issued by OP-5.
Even the
hospital stationeries (prescription pads) show ICSI in the column of
‘services offered’. Even in the Discharge slip ‘ICSI’ was mentioned.
Therefore, in my view the OP-5 performed ICSI, but not IVF. However, be
that as it may, the procedure ICSI or IVF was not the primary cause for the
different blood group of the twins.
5. The Court
rightly pointed out the passing the buck and blame game stand of the
Opponents on each other. The Court
held all that the opponents were
collectively involved Assisted Reproductive Techniques (ART).
6. The Court
therefore held that the present case is the fit case to apply the maxim Res
Ipsa Loquitor (the facts speak for themselves i.e. no more proof is
required to prove the negligence) . There is no need to
prove the negligent act of the OPs – 1 to 6. It was not a case of an
error of judgment by the treating doctors during the ART procedure, but it
sounds the unfair trade practices adopted by the OPs. They were pointing
fingers to each other, and everyone wants to shirk way from responsibility
and liability.
7.
The Court mentioned that the
allegations of Opponents range from professional rivalry between two doctors
or as the sperm count of the husband was very low, therefore the complainant
wife with the help of her relative Mr. Gambhir and the Doctor –Opp.No.6 got
the semen samples exchanged and that the
Hospital bill was not paid, all these allegations appear to be hypothetical and it was held
that “if and buts”
does not considered to be a cogent evidence. It itself proves the
glaring lapses of OPs 1 to 6 that how a third person was allowed in IVF lab
or during procedure. It also proves that no standard procedures were
followed by OPs.
8.
The Court observed that the role of Embryologist as a crucial person in the
ICSI/ IVF procedure, it is missing in the instant case. In the instant case
nothing is forthcoming about who was embryologist, who did the sperm
washing, the procedure of fertilisation etc. According to OP-5 her role
in the entire process was limited to the first and last step,
i.e., extraction of the ovum/ova and reinsertion of the fertilized ovum/ova
into the individual. However, the Court held that OP-5 and OP-6 were responsible for the
entire procedure. They have not disclosed about embryologist. In the
instant case, after the said incident, the hospital and directors (OPs - 1
to 4) have immediately got the premises vacated from OP-5 and since
then the premises was not given to any other IVF consultant.
Compensation :
a.
It was observed
that it should be borne in mind that the infertile couple was eager and
anxious to have a child of their own. The entire purpose of opting for an
Artificial Reproductive Technology such as IUI, IVF, ICSI, ZIFT, GIFT etc.
was to have good outcome. In the instant case due to the
negligence of OPs the genetic link between the parents and their children
has been severed. Its impact was on several social and
ethical issues.
b.
The negligent
act of OPs has caused parental confusion for the children and has left the
Complainants in the society for giving explanations to the children later
in life. There is great anxiety about the medical history and future
genetic disorders and future lifestyle.
c.
The catena of
judgments of Hon’ble Supreme Court, laid down different methods to
determine ‘just and adequate compensation’. It was held that
there is no restriction that courts can award compensation only up to what
is demanded by the complainant.
d.
The Court
relied on various judgments of Supreme Court and observed that is pertinent to note that the twin babies
are grown now, 14 years and both are healthy. The parents for last 14 years
have incurred expenses while bringing up the girls, the welfare, and
education etc. It is uncertain about the quality of sperm about
its genetic profile/inheritance. At this stage possibility of inherited
genetic disorders is unpredictable. Therefore, in my view the complainants
deserve adequate compensation. The blood group reports and the DNA profile
clearly prove that the Complainant No.2 was not a biological father.
e.
It is
pertinent to note that the delivered twins are female. Certainly, the
family genealogy has been irreversibly changed. They may carry the stigma
and face difficulties in future. The OP-1 hospital and OP 2 to 4 have
not followed the standard guidelines of ICMR. The OPs were just passing
on their responsibility on one another. Therefore, the negligence of
OP-1 to 6 has been conclusively established. The OP-1 hospital
was duty bound to provide quality services, but indulged in misleading
advertisement to allure the anxious infertile couples for ART and adopted
unethical practices. In my view, the instant case is of deceptive and
unfair trade practices adopted by the OPs who have forgotten professional
ethics. Thus, OPs-1 to 3 the hospital and directors, also the OPs - 4
to 6 liable for the act of negligence and unfair trade
practices. Thus, I fix the total lump sum liability of 1.5 Crore against
the OPs.
The OPs 1 to 3 are directed to pay jointly and severally Rs. 1 Crore
and the OPs – 4 to 6 shall pay Rs. 10 lakh each to the Complainants.
(ii) For the unfair trade practices, the OPs –
1 to 3 are directed to deposit Rs. 20 lakh in the Consumer Legal Aid
Account of this Commission.
(iii) The entire directions shall be complied within 6 weeks from
today, failing which the entire amount shall carry interest @ 8% per annum
till its realisation.
(iv) The total awarded amount of Rs. 1.30 Crore
shall be kept in the Fixed Deposit (in nationalised bank) in equal
proportion in the names of each twin till both attain age of majority. The
parents shall be nominee and they are permitted to withdraw periodic
interest for the care and welfare of the child.
Discussion on
ART (Assisted reproductive techniques)
a.
The Court has
discussed about the main topic of ART which raise complex ethical, social,
and legal issues. Some people or groups are opposed to any form of
technical interference in the 'natural process' of procreation.
b.
The use of
assisted reproductive techniques (ARTs) in human raises the
question of how to distinguish between what is a use and a misuse of an
ART. The core ethical issues identified include the unnatural means of
conception, inequitable access to ART due to its high cost, lack of
regulatory body, safety of the procedure, and fate of the embryos. Other
ethical problems are surrogacy, sex selection, and gamete donation. Thus
there is the need to formulate cultural and context-specific guidelines to
help address some of these ethical dilemmas.
c.
The painful
experience of women that not achieved a full-term pregnancy, the
burden and pain experienced by women undergoing ART treatment, and the
potential risks to women's health to be considered.
d.
There is no
uniform protocol specifying the sequenced application of intrauterine
insemination (IUI) followed by the enrolment of the woman in in vitro
fertilization (IVF) or intracytoplasmic sperm injection (ICSI). There is
need for non-technological solutions to infertility and the regulation of
medical practice.
e.
There are
challenges surrounding gamete and embryo donation, the use of surrogacy and
gestational carriers, the possible deleterious effects of ART, and the need
for regulations and laws to govern ART reporting and social
inequities.
f.
The Court has
also discussed about the mushrooming of ART clinics and how the proper protocols
are not being followed.
g.
ART specialist
requires a correct knowledge about the physiology of ovulation as well
as reproductive gynaecology. Routine gynaecologists who do not have
in-depth knowledge are also opening clinics as they think there is
money in it.
h.
There is need
to make it mandatory for the ART Centers to issue the DNA profiling of
baby(ies) born through ART procedures.
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