No cure/ no success is not negligence and fastening the liability on the treating doctor is not justified, the National Consumer Disputes Redressal Commission (NCDRC) has held as it took judicial notice of the fact that increasing number of people are opting for in-vitro fertilization due to growing problem of infertility while acknowledging that its failure cannot be attributed to the treating doctor given the complexity of procedure and medically recorded evidence of low success rate in women above 35 years of age.
The NCDRC bench of presiding officer Ajit Bharihoke and member Dr SM Kantikar said so while setting aside the order of the State Commission by which a doctor was asked to pay Rs 15 lakh compensation to her client after the IVF in her case failed.
“In vitro fertilization (IVF) is a complex series of procedures used to treat fertility or genetic problems and assist with the conception of a child. IVF involves several steps — ovulation induction, egg retrieval, sperm retrieval, fertilization and embryo transfer. One cycle of IVF can take about two weeks, and more than one cycle may be required. Infertility is a growing problem in India as well with the number of IVF cycles increasing,” the NCDRC bench said.
In the appeal moved by a senior doctor at Ganga Ram Hospital, the NCDRC noted that complainant, Haryana resident, aged 35 years, had way back in 1990 suffered ectopic pregnancy. After one more failed attempt, her husband and she consulted the doctor at Ganga Ram Hospital in 1999, who advised them to go for in-vitro fertilization.
An estimate of Rs 70,000 was given to them.
After undergoing various tests, she was declared fit for IVF. When she reached IVF lab sometime in July 1999, she was informed that the treatment would be done by lab staff.
In August 1999, upon insistence of a doctor posted in the IVF lab, they went to his residence for sperm survival test. The complainant was administered medicines and injections and assured that everything was progressing well and IVF/ embryo transfer (ET) will be done at proper time. The patient reported to IVF lab on 18-08-1999 at 12 noon. On the said date, three more patients were also called for the same. For the patient, IVF/ ET procedure was performed by the doctor (appellant).
While performing the procedure, the complainant was informed that she has developed infection, but there were 50 per cent chances of success.
In September 1999, the pregnancy test returned negative result.
In her complaint, the complainant alleged that she suffered irreparable loss and permanently lost her chance of future pregnancy; she had suffered severe mental shock and depression. She alleged that the doctor intentionally had done ET despite knowledge that it will become a failure. It could have been done in the next cycle after cure of the infection. After the ET, the couple desperately tried to contact the OP, but never got the appointment.
The opposite party resisted the complaint saying she is a senior consultant , had been working in Sir Ganga Ram Hospital since 1988, served as medical superintendent of hospital for 20 years and in 1989 established the first IVF centre of North India in the Gangaram Hospital. She had experience of work in the UK and USA for five years.
She said the patient and her husband never turned up for two years after five years. The OP had not given any guarantee that IVF must succeed.
According to medical literature, the success rate of IVF was only about 1/3rd. The counsel relied upon the RML Hospital Medical Board’s report and submitted several medical literatures on IVF/ET.
The NCDRC took reference from Text Book of Assisted Reproduction Techniques (4 Edition) by David K Gardener, some research articles from the journals like Human Reproduction-Update, Fertility and Sterility.
“It should be borne in mind that in-vitro fertilization (IVF) is a complex series of procedures used to treat fertility and assist with the conception of a child. It involves several steps — ovulation, induction, egg retrieval, sperm retrieval, fertilization and embryo transfer. The hospital or any treating doctor will not give assurances or guarantees of the treatment. There are chances of failure by the IVF also. Moreover, the patient was having sufficient time to choose or accept IVF depending on several factors for the treatment,” the bench said.
According to medical literature, the chances of having a healthy baby using IVF depend on many factors, such as patient’s age and the cause of infertility. In addition, IVF can be time-consuming, expensive and invasive.
The commission also perused the expert medical opinion from RML Hospital, New Delhi, which has commented on the instant case that success rate of IVF-ET, as per international standards, is 13.4% in women less than 35 years of age and 3.6% in women above 35 years and that failure of IVF-ET in the present case is in confirmation with the international standard.
The NCDRC noted that a woman’s age is the most important factor that influences the success rate of IVF procedures.
“Thus, the medical board observed that the OP has duly followed ICMR guidelines while treating the patient and the failure of IVF ET is known as per international standards. The IVF procedure is highly technical and the success rate is low in the cases of females above 35 years.
“In the instant case, the treating doctor adopted the standard method of IVF. The patient was properly investigated and given proper medicines for retrieval of eggs(ova) prior to IVF. Also SST was performed for her husband. In any given cycle, the chance of IVF success varies, depending on your age and your personal health circumstances. We do not find any deficiency or lapses in the duty of care on the part of OP,” the NCDRC held.