By Vikram Kilpady
Many married couples turn to in-vitro fertilisation (IVF) clinics to ensure they have children, without whom Indian society casts a pale eye on them for being unable to conceive. As a result, IVF clinics have mushroomed across cities, ironically much like the country’s population.
IVF has been a boon for many, starting in 1978 with the parents of India’s first test tube baby, but it is not without its problems. Most of it is, as is obvious, due to negligence, medical or otherwise.
A recent judgment of the National Consumer Disputes Redressal Commission (NCDRC) fining a West Delhi hospital Rs 1.5 crore for using the wrong semen sample for a couple in an Intra-Cytoplasmic Sperm Injection (ICSI) procedure has brought the distressing story to light. The hospital, its chairperson and director were ordered to pay Rs 1 crore to the couple. The two specialists involved in the procedure and the hospital’s medical director were also asked to pay the couple Rs 10 lakh each. The hospital was directed to deposit an extra Rs 20 lakh in the NCDRC’s consumer legal aid account.
The couple had gone for the IVF procedure, but was duped when the sperm used to fertilise the woman’s eggs was found to be not the husband’s. The offspring of that procedure, twin girls, are 14 years now. The family got to know of the wrong sperm specimen when they conducted a paternity test at the Centre for Cellular and Molecular Biology, Hyderabad, upon finding that one of the daughters had a blood group which was not compatible with that of her parents. The test said the husband was not the father of that child.
In September 2008, the complainant couple approached Bhatia Global Hospital and Endosurgery Institute in West Delhi’s Paschim Vihar for an ICSI procedure, as recommended by their doctor. Following consultations with the hospital’s IVF centre specialists, Dr Archana Dhawan Bajaj and Dr Indira Ganeshan, they opted to go in for the procedure when assured that it would enable them to have babies. The couple already had a child, a daughter, through the same procedure in 2006 at a different Delhi hospital.
Accordingly, they did the procedure from October 13 to 15, when the embryo transfer was done. Pregnancy was confirmed on November 4, 2008, and the twins were born in June 2009.
After the paternity test, the complainant couple moved consumer court in 2010 for Rs 2 crore damages for negligence and deficiency in service. They contended that the medical negligence created emotional stress, family discord, a fear of genetically inherited diseases, etc.
NCDRC presiding member Dr SM Kantikar, who passed the order, underlined the urgent need for a prompt and fixed timeline for accreditation of Assisted Reproductive Techniques (ART) clinics in view of their mushrooming across the country. Kantikar said there was a need to make it mandatory for ART centres to issue DNA profiling of offspring born through ART procedures. A copy of the order has been sent to the National Medical Council as well as the Health and Family Welfare Ministry for necessary directions.
The order notes: “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 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.”
Further, the NCDRC order states: “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.”
While the Commission said the genetically inherited diseases angle was unpredictable, it did say that the hospital seemed to have indulged in unfair trade practices, including the doctors involved in the IVF procedure. As in all cases, the hospital, its director and the IVF consultant and her colleague sought to blame each other for the very serious lapse. The Commission said everyone wanted to shirk their responsibility and liability by blaming the other.
The fact that the children of the botched-up ICSI procedure were girls was not lost on the Commission. “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,” it said.
With that in mind, the NCDRC ordered that the total awarded amount of Rs 1.30 crore shall be kept in a fixed deposit in a nationalised bank divided equally in the names of the twins till they attain the age of majority. The parents will be the nominees and have been allowed to draw on the interest for the children’s care and welfare.
The Commission also went into who actually had done the alleged mixing of sperm. The order names the two IVF centre specialists and one more person who was in the lab during the procedure. The hospital and the IVF specialists said the complainants knew that the husband had low sperm count, which could lower chances of conception. But with the couple and one of the specialists wanting them to have another child, the Commission noted that it was “very much possible that they might have intentionally given the wrong sample”.
The Commission also noted that there was more than a sliver of professional rivalry or jealousy between the IVF specialists and said it could have spurred the specialist to give the couple the wrong sample.
Curiously, the Commission noted that the specialists had not named the embryologist who was part of the procedure. “The role of an embryologist as a crucial person in the ICSI/IVF procedure is missing in the instant case. The process of IVF is a complex process where first the ovum is extracted from the female and the partner is then required to provide semen sample (sperm) to the embryologist. The sample is then labeled and processed by the embryologist. He undertakes cleaning/washing of the sperms, a complex scientific process. Thereafter, the ovum is fertilised with the washed sperm and the fertilised ovum is then reinserted into the uterine cavity of the individual patient which further pregnancy continues. In the instant case, nothing is forthcoming about who was the embryologist, who did the sperm washing, the procedure of fertilization, etc.”
The order took exception to the hospital’s attitude as well. “It itself proves the glaring lapses of the hospital and the specialists that how a third person was allowed in the IVF lab or during the procedure. It also proves that no standard procedures were followed by the hospital and the specialists.”
It is obvious that this market is not regulated enough, thereby taking desperate couples yearning for parenthood for a ride.