Expressing serious concerns over medical ethics, unfair practices and misleading advertisement by assisted reproductive technology (ART) centres while performing in vitro fertilisation (IVF), the national consumer disputes redressal commission (NCDRC) directed New Delhi-based Bhatia Global Hospital & Endo-surgery Institute, its chairman and director and three doctors to jointly pay Rs1.50 crore to the patient for negligence and unfair trade practices.
In an order issued earlier this month, the bench of Dr SM Kantikar (presiding member) at NCDRC says, "Mushrooming of ART clinics has led to incorrect treatment to patients. ART specialist requires 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 infertility patients are stressed both emotionally as well as financially and the incorrect treatment increases this. Use of adjuvant therapies, which still does not have evidence, increases the cost to the patient. Moreover, mushrooming of the clinics has made rampant unethical practices in our country."
"ART clinics are moving to donor gametes very early and also when not indicated just to increase the success rate of the clinic. Moreover, the mixing of gametes and the use of donor gametes is being done without the knowledge of the patient. There is a need for a prompt and fixed timeline for accreditation of ART clinics from the authorities," he says.
NCDRC also recommended the National Medical Council and Union ministry of health and family welfare make it mandatory for the ART centres to issue DNA profiling of baby(ies) born through ART procedures.
The case is related to the Tandon family which, on advice from Dr Archana Dhawan Bajaj, approached Bhatia Hospital for intra-cytoplasmic sperm injection (ICSI). After assurance from Dr Indu Bhatia, the director of the Hospital and Dr Indira Ganeshan, the couple underwent the ICSI procedure at the Hospital in October 2008.
On 15 June 2009, Ms Tandon gave birth to female twins. However, the blood group of one of the babies was nowhere matching to the Tandons’. A DNA profile test on 11 December 2009, conducted at the Centre for Cellular and Molecular Biology (CCMB), revealed that Mr Tandon was not the biological father of the twins.
Being aggrieved, the couple filed a complaint to claim Rs2 crore as compensation for the alleged negligence and deficiency in service which created emotional stress, family discord and fear of genetically-inherited diseases.
During the hearing, Bhatia Hospital, RH Bhatia, chairman of the Hospital, and Dr Indu Bhatia submitted that there are several disputed and complicated questions of facts, which could not be decided in summary proceedings, thus the matter should be referred to the civil courts.
Dr Indu Bhatia submitted that the Tandons’ treatment was duly performed by Dr Archana Dhawan Bajaj and Dr Indira Ganeshan, who are very competent in their fields and have specialisation in the field. "The laboratory and operation theatre (OT) for IVF had been set up by Dr Archana Dhawan Bajaj at her own costs and expenses and remained under her lock and key. The entire set-up, including the salary of technicians, anaesthetists, and embryologists and nursing staff, was done by her. The staff of IVF laboratory was not on the payroll of the Hospital," she contended.
Dr Archana Dhawan Bajaj, on the other hand, contended that Dr Indu Bhatia is the sole in-charge of the IVF lab and OT and all activities and procedures were carried on after her approval and consent. She says, "...as requested by the Hospital management, she provide(s) her services as an IVF specialist to the patients on normal consultancy terms of 50:50 ratio (50% Consultant, 50% Hospital). The understanding with the Hospital that all the infrastructure like the laboratory and OT for the IVF procedure, would be set up by the Hospital, and all expenses of the assisting doctors, like the anaesthetic doctor, ultrasonologist and nursing staff, would be maintained and monitored by the Hospital at their own cost."
She also 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. "In the instant case, the extracted oocytes were handed over to the embryologist. The semen sample of the male was then handed over to the embryologist, who then washed, cleaned and prepared. The washed sperm samples were labelled under the supervision of Dr Parveen Bhatia, medical director of Bhatia Hospital. The oocytes and sperm samples for incubation were then left in the incubator for a period of approximately four hours. During this period, the lab remained locked and the keys were handed over (to) the staff of the Hospital. Therefore, at no point of time the keys of the IVF Lab were in my custody either before or after the IVF procedure."
After hearing all parties and perusing the records, NCDRC observed that all the opposite parties (OPs) had made cross-allegations between themselves. Dr Kantikar also referred to the standard textbooks on 'Immunohematology', the genetic transmission of possible blood groups from parents to the baby.
"Admittedly, the blood groups of twins differ from their parents. One of the twins was AB-positive, whereas Ms Tandon was B-positive, and Mr Tandon was O-negative. Thus, it is clear that due to the negligence of OPs during ICSI or IVF procedure, such disaster occurred," the bench observed.
The OPs, throughout their evidence, were pointing fingers at each other and resorting to shifting their blame, Dr Kantikar says, adding, "In my view, the OPs were collectively involved ART. Thus, considering the entirety, the instant case is of Res Ipsa Loquitor. There is no need to prove the negligent act of the OPs. It was not a case of an error of judgment by the treating doctors during the ART procedure, but it sounds like the unfair trade practices adopted by the OPs. They pointed fingers at each other, and everyone wanted to shirk away responsibility and liability."
Referring to the compensation, NCDRC noted that there is a need to consider the ripple effects of gross negligence. It says, "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. The negligent act of OPs has caused parental confusion for the children and has left the Tandons in the society for giving explanations to the children later in life."
"It is pertinent to note that the twin babies are grown now, 14 years, and both are healthy. The parents, for the last 14 years, have incurred expenses while bringing up the girls, the welfare, and education. It is uncertain about the quality of sperm about its genetic profile or inheritance. At this stage possibility of inherited genetic disorders is unpredictable. Therefore, in my view, the complainants deserve adequate compensation," the bench added.
Dr Kantikar from NCDRC then directed Bhatia Hospital, its chairman Mr Bhatia, and director Dr Indu Bhatia to jointly and severally pay Rs1 crore. The three are also asked to deposit Rs20 lakh in the consumer legal aid account of NCDRC. Dr Parveen Bhatia, Dr Archana Dhawan Bajaj and Dr Indira Ganeshan were directed to pay Rs10 lakh each to the Tandons. They all have to pay the money within six weeks.
Further, the bench directed to keep the award money of Rs1.30 crore in fixed deposit (FD) of a nationalised bank in equal proportion in the names of each twin till both attain the age of majority. "The parents shall be the nominee and they are permitted to withdraw periodic interest for the care and welfare of the child," it added.
(Consumer Case No14 of 2010 Date: 16 June 2023)
