Delhi Hospital slapped Whooping Rs 1.5 crore compensation for Sperm Mix up by infertility center operating inside the hospital

New Delhi: In a recent judgment, the National Consumer Disputes Redressal Commission (NCDRC) has penalized Delhi-based Bhatia Global Hospital and its doctors with a fine of Rs 1.5 crore for negligence while providing Assisted reproductive techniques to a couple and resorting to unethical practices.

Even though the couple gave birth to twins after going through Intra-Cytoplasmic Sperm Injection (ICSI) procedure, after conducting a paternity test, it was revealed that the male complainant was not the biological father of the babies.

While holding the hospital and doctors negligent, the Consumer Court also expressed its concern regarding unethical practices being used in ART clinics and noted, "ART clinics are moving to donor gametes very early and also when not indicated 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 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. 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," it further noted.

Opining that there is a need for prompt and fixed time line for accreditation of ART clinics from the authorities and stressing upon the need to make it mandatory for the ART Centres to issue the DNA profiling of baby (ies) born through ART procedures, the NCDRC bench has also sent a copy of the order to National Medical Council and Union Health Ministry for necessary directions to the ART centres.

The matter goes back to 2008 when a couple, on the advice of Dr. Archana Dhawan Bajaj, approached Bhatia Global Hospital and Endosurgery Institute, New Delhi for Intra-Cytoplasmic Sperm Injection (ICSI). 

Dr. Bajaj and Dr. Bhatia assured the couple about the success of ICSI. Accordingly, the couple got admitted in the hospital and first step of the ICSI procedure was completed. Consequently, embryo transfer was done in the patient and her pregnancy was confirmed after a few days. She gave birth to female twins on 16.06.2009. 

However, the blood group of one of the twins revealed to be AB(+), which was not a possible outcome as the blood group of the parents was B (+) and O(-) for the mother and the father respectively. 

Thereafter, a Paternity test (DNA profile) was conducted at Centre for Cellular and Molecular Biology (“CCMB”) Hyderabad. It revealed that the Complainant was not the biological father of the twins. Being aggrieved the couple approached the NCDRC bench and filed the Consumer Complaint and claimed 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.

On the other hand, the doctors and the hospital denied any negligence on their part. The hospital, Dr Bhatia and Dr Bajaj submitted that Dr. Bajaj and Dr Ganeshan were the personal doctor of complainants. Dr. Bajaj was not a regular doctor on the roll of the hospital. It was further submitted that the I.V.F laboratory set up by Dr. Bajaj was absolutely separate & distinct from the hospital laboratory and the I.V.F laboratory had been maintained & monitored by Dr. Bajaj at her own costs. They also submitted that the hospital and directors were 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.

Dr. Ganeshan submitted that Dr. Bhatia and the Director of the Hospital was the sole in charge of the IVF lab/OT. All activities/procedures etc. were carried on after her approval/consent. 

It was further submitted by Dr. Ganeshan that the extracted oocytes were handed over to the embryologist. The semen sample of the male, which was received by Dr Praveen Bhatia, was then handed over to the embryologist, who then washed, cleaned and prepared. The washed sperm samples were labelled under the supervision of Dr. Praveen Bhatia.

She further submitted that 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 the hospital. Therefore, at no point of time, the keys of the IVF Lab were in custody of Dr. Ganeshan either before or after the IVF procedure. The case sheet, along with the consent form were under the custody of the Hospital.

Dr. Ganeshan further confirmed that mixing could have happened at two stages i.e. at the stage of collection of semen or during storage for four hours before insemination. It was further submitted that at the time of collection of semen sample, on the insistence of the Complainants, one Mr. Gambhi, who was a close relative of the complainants, was present in the I.V.F laboratory and also in semen collection room. 

Thereafter, the sample of the semen was handed over to Dr. Praveen by the relative and referring to this, Dr. Ganeshan argued before the consumer court that there was every possibility that the alleged mixing was done by the relative without the knowledge of the complainant.

After considering the submissions, the top consumer court also referred to the text books on ‘Immunohematology’ to discuss how genetic transmission of possible blood groups from parents to the baby is reproduced. 

Taking note of the blood groups of the twins and the complainants, the top consumer court held the hospital and the doctors negligent and noted, "Admittedly, the blood groups of twins differ from their parents. One of the twins was ABPositive whereas the Complainant No.1 was B-Positive and Complainant No.2 was O- Negative. Thus, it is clear that due to the negligence of OPs during ICSI or IVF procedure, such disaster occurred."

Further, the Commission also perused the Paternity Test Report dated 09.12.2009 issued by CCMB the institute of national repute and noted, "The report concluded that the children are not related to the Complainant No. 2, it means he was not biological father of the twins."

In the report, CCMB concluded, “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 Consumer Court noted that back in the year 2006, the couple underwent successful ICSI at Batra Hospital and gave birth to their first daughter. The NCDRC further noted that the sperm count of the male complainant was very low and therefore the procedure other than ICSI would not be successful for the couple.

"It is pertinent to note that word ‘ICSI’ was clearly mentioned in the prescriptions issued by OP-5. Even the hospital stationaries (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," the Apex consumer court noted in this context.

"The OPs throughout their evidences were pointing fingers to each other and resorting to shift their blame. In my view the OP-1 to 6 were collectively involved Assisted Reproductive Techniques (ART). The contention of OP-1 to 4 was that they are not responsible for the act of the OP- 5. It is pertinent to note that by their own admission the OP-1 to 4 have provided accommodation and facilities with work understanding in the ratio of 25:75 with the OP-5. The OP-6 was closely involved and associated with OP- 5 during the entire procedure. Moreover, OP- 6 was involved in 6-7 other IVF procedures in the same lab which proves it was joint involvement of the OPs. It also proves the role of OP-6 in the procedure," it further noted.

Holding the hospital and the doctors guilty of negligence, the Commission observed, "Thus, considering the entirety, the instant case is of Res Ipsa Loquitor. 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."

The NCDRC bench also addressed the arguments by the doctors and hospitals, who had questioned the authenticity of report issued by CCMB. It was argued by them that it was specifically stated in the report as “Private Case; No legal locus standi’. It was also mentioned that, ‘this report is only for personal use and not for legal purpose’.

Referring to this, they argued that the tests were carried out at the back of them and as such the possibility of the alleged tests being forged, fabricated, and manipulated cannot be ruled out.

However, at this outset, the Consumer Court noted,

"I don’t find any force in the above submission. Moreover, by the disclaimer in the report ‘only for personal use and not for legal purpose’, the scientific basis and interpretation of DNA (paternity test) will not lose its significance. The CCMB is one of the reputed govt. institutions and DNA analysis is accepted throughout the country."

Meanwhile, in order to avoid any controversy and to give fair opportunity to the parties, the consumer court had ordered a repeat paternity test for the twins from the Department of Forensic Medicine at AIIMS, New Delhi. However, the AIIMS replied that they are not conducting DNA profiling now. Therefore, the top consumer court decided to proceed with the CCMB report.

Addressing the allegations of the hospital and doctors regarding a possible collusion, connivance & malafide intentions of complainants for the mixing up of the sperm, the top consumer court held,

"The stand taken by OPs appears just hypothetical, “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."

"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, I am of the view 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," it further opined.

"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 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 consumer court observed in the judgment.

In order to decide a just and adequate compensation, the top consumer court referred to Supreme Court orders in the case of Sarla Verma & Ors. vs Delhi Transport Corp. & Anr, and Dr. Balaram Prasad vs. Dr. Kunal Saha & Ors and noted,

"It 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."

Therefore, opining a lump sum compensation of Rs 1.5 crore would be just, the Consumer court mentioned,

"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."

In this regard, the Consumer Court issued the following directions:

(i) 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.

To read the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-rs-15-crore-compensation-212726.pdf

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