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Synopsis

The National Consumer Dispute Redressal Commission (NCDRC) has fined the Bhatia Global Hospital & Endosurgery Institute and its doctors with Rs. 1.5 crores for negligence in IVF treatment and adopting “unethical practices”.

Presiding member Justice S.M. Kantikar was hearing a complaint by a woman and her husband who after nearly 15 years found out that their twin children had been conceived by a semen sample that was not of the intended biological father (the husband).

The commission expressed concerns over the use of assisted reproductive techniques (ARTs) in humans and distinguished between use and a misuse of an ART.

“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”, the commission said in its order dated June 16.

It noted that the mix ups of gametes and use of donor gametes is being done without knowledge of the patient and that the mushrooming of ART clinics is leading to incorrect treatments to 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. One must realise that the infertility patients are stressed both emotionally as well as financially and the incorrect treatment increases this…..Moreover mushrooming of the clinics has made rampant unethical practices in our country”, it said.

In 2008, the couple approached Bhatia Global Hospital and Endosurgery Institute for an Intra-Cytoplasmic Sperm injection (ICSI). Following the procedure, the woman gave birth to female twins on June 15, 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 December 11, 2009, Paternity test (DNA profile) was conducted at Centre for Cellular and Molecular Biology (“CCMB”) Hyderabad. It revealed that the Complainant No. 2 (husband) was not the biological father of the twins.

Being aggrieved the couple filed the instant Consumer Complaint to claim Rs. two crore as compensation for the alleged negligence and deficiency in service which created emotional stress, family discord, fear of genetically inherited diseases etc.

Considering the entirety of the instant case, the Commission said that there was no need to prove the negligent act of the opposite parties (OPs). It was not a case of an error of judgment by the treating doctors during the ART procedure, but it sounds like “unfair trade practices” adopted by the OPs. “They were pointing fingers to each other, and everyone wants to shirk way from responsibility and liability”, it added.

The court said that ARTs raise complex ethical, social, and legal issues and 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”, it added.

It further remarked that 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”, it said.

Noting that the woman delivered female twins, the Commission stated that certainly the “family genealogy has been irreversibly changed” and they may carry the stigma and face difficulties in future. “Therefore, the negligence of OP-1 to 6 has been conclusively established”, it said.

Conclusively, the Commission ordered, “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”.

Case Title: X & Anr. v. Bhatia Global Hospital & Endosurgery Institute & Ors.