National Consumer Disputes Redressal Commission (NCDRC): While deciding the instant complaint wherein a paternity test had revealed that complainant-2 was not the father of the twins born to his wife via Intra-CytoplasmicSperm injection (ICSI) and had thereby alleged medical negligence on part of the hospital; the bench of Dr. S.M. Kantikar (Presiding Member) held the hospital to be negligent and liable for unfair medical practices. Pointing out that the hospital was duty bound to provide quality services but indulged in misleading advertisement to lure anxious infertile couples for Artificial Reproductive Techniques (ART) and adopted unethical practices, the Commission determined a total lump sum liability of INR 1.5 Crores against the opposite parties.
Background: In September 2008, the complainants 1 and 2 (aggrieved couple) on advice of the doctor (OP-5) approached Bhatia Global Hospital for Intra-Cytoplasmic Sperm Injection (ICSI). The doctors, OP-4 and OP-5 assured the anxious couple about the success of ICSI.
In October 2008, the couple got admitted in the hospital and first step of ICSI procedure was completed. For the next stage, the embryo transfer was done, and thereafter, pregnancy of complainant 1 was confirmed. In June 2009, she gave birth to twin girls.
The blood group of one of the twins was revealed to be AB (+), which was not a possible outcome as blood group of the parents was B (+) and O (-). Therefore, in December 2009, a paternity test was conducted, and it was revealed that the complainant 2 was not the biological father of the twins and there was a mix-up in the sperm samples during the first stages of Intra-CytoplasmicSperm injection (ICSI). Thus, the aggrieved couple filed the instant Consumer Complaint to claim Rs. 2 crores as compensation for alleged negligence and deficiency in service which created emotional stress, family discord and fear of genetically inherited diseases etc.
Contentions: The opposite parties (OP) denied the allegations of negligence citing that there are several disputed and complicated questions of facts, therefore, could not be decided in summery proceedings, thus matter be referred to the Civil Courts.
OP-4 contended that the complainants’ treatment was duly performed by competent doctors OP-5 and OP-6 (complainants’ doctor) who 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. The entire arrangement including salary of the 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.
OP-5 submitted that OP-4, who was the Director of Fertility Centre in Bhatia Global Hospital was the sole in charge of the IVF lab/OT. All activities/procedures etc. were carried on after her approval/consent. She further submitted that she was only a visiting consultant at Bhatia Hospital and her role was limited to extracting the oocytes (eggs) from the female patient.
The OP-5 further stated the sperm mix-up could have happened at two stages i.e., at the stage of collection of semen or during storage for four hours before insemination. She pointed out that in the instant case, at the time of collection of semen sample, a close relative of the complainants, was present in the I.V.F. laboratory and in semen collection room. She alleged that the complainants were in cahoots with their close relative to besmirch the name of the opposite parties.
The Commission analysed a list of genetic transmission of possible blood groups from parents to the baby and the results of the paternity test undergone by complainant 2.
Determining that whether the procedure performed on the couple is IVF (intra-vitro fertilization) or ICSI, the Commission pointed out that the sperm count of the Complainant 2 was very low and therefore any procedure other than ICSI would not have been successful for the instant couple. It was further noted that word ‘ICSI’ was clearly mentioned in the prescriptions issued by OP-5.
Perusing the facts and contentions of the case, the Commission noted that the opposite parties have made cross-allegations between themselves. Commission was of the view that the opposite parties were collectively involved Assisted Reproductive Techniques (ART). The Commission pointed out that the instant case was of Res Ipsa Loquitor (facts speak for themselves). “There is no need to prove the negligent act of the Opposite Parties. 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 away from responsibility and liability”.
The Commission stated that disclaimers like “only for personal use and not for legal purpose” in the paternity test report does not affect the scientific basis and interpretation of DNA (paternity test).
Considering the next issue as to who was responsible for alleged mix-up of sperm sample, the Commission noted that there are many people who can be put under suspicion; for e.g., the complainants’ close relative; OP-5 or 6 or the staff or the Complaints themselves. Once again taking note of the cross-allegations amongst the opposite parties, the Commission pointed out that the stand taken by them appears just hypothetical, “ifs and buts”. 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. The role of Embryologist as a crucial person in the ICSI/ IVF procedure, which is missing in the instant case.
Pointing out that ICSI/IVF is a complex process and in the instant case it is not clear that who was embryologist, who did the sperm washing, the procedure of fertilisation etc., the Commission was of the view that OP-5 and OP-6 were responsible for the entire procedure.
The Commission was further of the view that vis-à-vis determination of compensation in this case, the ripple effects of this negligence needs to be considered. The couple was eager and anxious to have a child of their own. The entire purpose of opting for an Artificial Reproductive was to have good outcome. In the instant case due to the negligence of opposite parties the genetic link between the parents and their children has been severed, thereby creating several social and ethical issues. 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”.
The Commission noted that the twin babies are now 14 years old, and both are healthy. The parents for last 14 years have incurred expenses while bringing up the girls, the welfare, and education etc. There is uncertainty about the quality of sperm about its genetic profile/inheritance. At this stage possibility of inherited genetic disorders is unpredictable. Therefore, the Commission was of the view that complainants deserve adequate compensation.
NCDRC’s Observations on ART- Challenges and Required Reforms
Given the nature of the matter, the Commission deemed it fit to put forth crucial points in the larger interest of couples who opt for ART-
Assisted reproductive techniques (ART) raise complex ethical, social, and legal issues. The use of assisted reproductive techniques (ARTs) in human raises question of how to distinguish between use and misuse of ART. Thus, there is need to formulate cultural and context-specific guidelines to help address some of the ethical dilemmas associated with ART.
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. 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.
ART clinics are moving to donor gametes very early just to increase the success rate of the clinic. Moreover, mixing of gametes and use of donor gametes is being done without the knowledge of the patient.
Mushrooming of ART clinics has led to incorrect treatment of patients. 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. Incorrect protocols are being used and the treatment offered may not be correct.
There is a need to realise that infertility patients are stressed both emotionally as well as financially and the incorrect treatments increase this stress even more. Use of adjuvant therapies increases the cost to the patient. Moreover, mushrooming of the clinics has made rampant unethical practices in our country.
There is need for prompt and fixed timeline for accreditation of ART clinics from the authorities.
It should be mandatory for ART Centres to issue the DNA profiling of babies born through ART procedures.
[X v. Bhatia Global Hospital and Endosurgery Institute, 2023 SCC OnLine NCDRC 212, decided on 16-06-2023]
Order by Dr. S.M. Kantikar (Presiding Member)
Advocates who appeared in this case :
For the Complainants: Chaitanya, Advocate;
For OP-1 to 4: Amit Sharma, Advocate and Mukesh Garg, Advocate;
For OP-5: Angad Mehta, Advocate;
For OP-6: Manisha Singh, Advocate.