NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION
NEW DELHI
 
FIRST APPEAL NO. 368 OF 2011
 
(Against the Order dated 28/07/2011 in Complaint No. 240/2001 of the State Commission Delhi)
1. DR. M. KOCHAR
Senior Consultant Obs. Gynae, Sir Ganga Ram Hospital, Rajinder Nagar,
New Delhi-110060
...........Appellant(s)
Versus 
1. ISPITA SEAL
Leisure Valley Apartment Society, Flat No. 50-B, Sector - 46,
Faridabad - 121 010
Haryana
2. ISPITA SEAL
Also At I-241, Sarojini Nagar,
New Delhi - 110 023
...........Respondent(s)

BEFORE: 
 HON'BLE MR. JUSTICE AJIT BHARIHOKE,PRESIDING MEMBER
 HON'BLE MR. DR. S.M. KANTIKAR,MEMBER

For the Appellant :
Ms. Sonia Sharma, Advocate
For the Respondent :
In person

Dated : 12 Dec 2017
ORDER

DR. S. M. KANTIKAR,  MEMBER

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.

1.       The relevant brief facts to dispose of this appeal are that Mrs. Ispita Seal, 35 years old lady (herein referred as the patient), way back in 1990 suffered ectopic pregnancy, that time her right fallopian tube was removed. The then doctor had assured that she had again chance of pregnancy as the left fallopian tube was patent and intact. Thereafter, in May 1992, she got pregnant but unfortunately it was again ectopic pregnancy. She took treatment and the doctor removed the pregnancy and the fallopian tube was saved. Furthermore, from January 1993  till 1999 for six years  she took infertility treatment at AIIMS and Safdarjung Hospital, New Delhi under CGHS. On 3.3.1999, patient along with her husband consulted Dr. Kochar, the OP, a Senior Gynaecologist at Sir Ganga Ram Hospital, New Delhi ( in short, “Gangaram Hospital). The OP after going through the patient’s past history advised for In Vitro Fertilisation (IVF) treatment which was the only option for her infertility. The OP did not suggest any alternate method of treatment except IVF. Therefore, because of long desperation of infertility the couple agreed for IVF treatment in the hands of OP. The OP gave total estimate for the treatment around Rs.65,000/- to Rs.70,000/-. The patient underwent several laboratory investigations and hormonal assessment. Her D&C was performed on 26-06-1999. The patient was declared to be fit for IVF after all investigations. The husband’s semen was also tested on 21-07-1999 and thereafter the OP called the patient for IVF on 23-07-1999 at Ganga Ram Hospital. Accordingly, on 23-07-1999 the patient went to IVF lab in early morning but the OP was not available. She was informed that now onwards the treatment will be done by the staff of the IVF lab only. Accordingly, she was instructed to come on 2nd day of her next menstrual cycle, at 8:30 A.M.. Accordingly, on 02-08-1999 the patient reached IVF lab., she was given three ampoules of Metrodin injection and few other medicines. A follicle monitoring chart was given which did not bear signature of the OP, Dr. Kochar. She was followed by ultrasound monitoring for the development of eggs. The report was not intimated to the patient in spite of repeated requests. The hospital staff did not allow her or her husband to meet Dr. Kochar since 02-08-1999, all the treatment and medicines were given by nurses and lab technicians only.

2.       On 06-08-1999, Dr. Raj Gaur who was present in the IVF lab told her husband that his semen analysis and Sperm Survival Test (SST) to be done at Gautam Nagar where he resides but, the husband resisted the suggestion and insisted for the tests to be conducted in IVF lab itself at Gangaram Hospital. But, there was no option,  the husband of patient have to visit the residence of Dr. Raj Gaur on 08-08-1999. The sample was collected within the toilet in empty glass bottle, he paid Rs.400/- for SST charges. Dr. Gaur gave SST report on plain paper on the same day, stating that semen report was okay. As per instructions, injections and medicines were administered to the patient till 17-08-1999 and she was given assurance that everything of progress 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 same day three more patients were also called for the same. For the patient IVF/ ET procedure was performed by OP-Dr.Kochar, it took more than 40 minutes. Dr. Kochar while performing ET told the patient that “you have developed infection”. On hearing it, patient requested OP to stop ET procedure. The husband of complainant met Dr. Raj Gaur, asked about the cause of infection and why it could not be detected before performing ET but there was no avail. On the same day evening her husband met the OP-Dr. Kochar and tried to seek clarification about infection at ET. She avoided to answer, but said that she was still hopeful of 50-50 chances. She further said that don’t worry if the process fails, she will again do ET for which eggs have been kept safely. As alleged by the complainant, the prescription (Annexure 10), has  clearly mentioned that “ET done with difficulty”. On 01-09-1999, the pregnancy test revealed negative result. Similarly the other two patients also not conceived.

3.       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 OP intentionally had done ET despite knowledge that it will become a failure. It would have been done in the next cycle after cure of the infection. After the ET, couple desperately tried to contact OP, but never got appointment to see OP1. It was a cheating and crime against womanity. Therefore,  complainant filed a complaint before the Delhi State Consumer Disputes Redressal Commission (for short, “the State Commission”) and prayed for refund of Rs.66,702/-, the charges paid for IVF and Rs.15,00,000/- towards compensation on account of wilful negligence.

4.       The opposite party resisted the complaint, filed a written version. The opposite party submitted that,   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 UK and USA for five years. She submitted that the patient was taking treatment for infertility since 1990 from various centres. The complainant has not filed any medical record of previous treatment taken at Maternity Hospital during 1990 to 1992. The patient approached OP in July 1999, after clinical assessment she was advised for IVF. She was also informed about no guarantee of success of the procedure. The failure rate of IVF are more, the success rate of IVF varies between 25% to 30%. The complainant was properly investigated. She made payment as per schedule of Ganga Ram Hospital. The process of IVF is highly technical and specialised which comprised of teams of doctors, embryologist and various technical staff. Dr. Raj Gaur is a most experienced embryologist at that time in Ganga Ram Hospital. The SST conducted by Dr. Raj Gaur was absolutely essential. The opposite party denied the total averments and allegations made by the complainants. Dr. Raj Gaur, had also   filed an affidavit of evidence and submitted that the patient was correctly  managed as per IVF Protocol. After the IVF procedure, the couple never turned up for two years.

5.       Considering the pleadings, evidence and medical record, the State Commission allowed the complaint and directed the opposite party to pay Rs.15,00,000/- along with interest at the rate of 9% per annum from the date of filing of the complaint. Being aggrieved by the order of the State Commission, the opposite party preferred first appeal before this Commission.

6.       We have heard both the parties. The learned counsel for the appellant, Ms. Sonia Sharma, who was present with the appellant Dr. Kochar, vehemently argued that , there was no deficiency in service during treatment of IVF, the procedure was  performed as per standard protocol. Counsel submitted that for SST the patient’s husband was sent to Dr. Gaur’s Clinic, a Senior Embryologist. SST was necessary to find out quality of sperm and to exclude the morphology and abnormality of sperms. She further submitted routinely similar procedure was followed for husbands of other patients.  Dr. Gaur had a well-equipped laboratory for Seminology and SST. The said facility was not available with Gangaram Hospital. The SST report was handed over to the patient and findings were clearly mentioned in the discharge summary. The medicines were prescribed by OP to achieve good eggs production and to improve implantation of embryo in the patient.

She further submitted that there was no infection during IVF implantation. The OP never told the patient about the infection, and there was no proof of any infection. Due to hormonal effect there will be a physiological rise in Estradiol which causes excessive clear discharge from vagina, it cannot be construed as infection. Even otherwise presence of vaginal infection does not alter the pregnancy.

 No injection was given to the patient while undergoing IVF/ET, but  at the time of discharge the Tab.Augmentin for 5 days was advised  to the patient. In view of abundant precaution to avoid infection,  routinely antibiotic  was given  to all patients after ET. Thus, It was for a precautionary measure and if in case there is any kind of infection the same would be cured.  Counsel further stated that, OP had not given any guarantee that IVF must succeed.

According to medical literature,  success rate of IVF was only about 1/3rd.  The counsel relied upon the RML Hospital Medical board’s report, and opinion of Dr. Bukshee. To support her argument, the counsel had submitted several medical literatures on IVF/ET, viz.,

i)        A textbook of In Vitro Fertilization and Assisted Reproduction by Jaypee Brothers.  

ii)       The subfertility handbook: a clinician’s guide, Cambridge University Press.

iii)      IVF Clinic Success Rates-2000, www.foresight-preconception.org.uk/news-views/IVFstats1.html.

 

The Cousel also relied upon the decisions of Hon’ble Supreme Court in Kusum Sharma & Ors. Vs. Batra Hospital & Medical Research Centre & Ors. 1(1010) CPJ 29 (SC) wherein the Hon’ble Supreme Court relied the judgment in Bolam Vs. Friern Hospital Management Committee, (1957) 1 WLR 582.

7.       The complainant and her husband argued the matter. The rival contentions that, the OP to grab money intentionally advised IVF. The procedure was done by OP when there was infection.  OP should have avoided the IVF/ET procedure at the first cycle which knowingly was an unsuccessful attempt. The complainant suffered    mental and physical agony with financial loss. The complainant’s husband submitted that, he had produced samples of semen at the residence of Dr. Gaur in the toilet, which itself was unhygienic procedure. He submitted that there was vast difference in the sperm count between initial report and later report. It was 53 millions on 5/8/1999 whereas 75 million (18.8.199) as mentioned in the discharge summery. He further submitted that OP never checked the patient and was never accessible to them. After IVF procedure at  Gangaram Hospital,  Dr.Kochar was never turned back. He further submitted that, already his wife had suffered twice ectopic pregnancy, and waiting for long years for the pregnancy, but due to unsuccessful attempt of OP, his wife sustained irreparable loss. The couple lost their hope of conceiving and having a child in their future lifetime, because of total negligence of OP.

8.       We gave our thoughtful consideration to the arguments advanced before us. We have examined the entire evidence, available medical record and literature on the subject of IVF/ET. We took reference from Text Book of Assisted Reproduction Techniques (4th Edition) by David K. Gardener, some research articles from the journals like Human Reproduction-Update, Fertility and Sterility.   

  • In the instant case, it is an admitted fact that, the patient had suffered ectopic pregnancy twice and she had lost her one fallopian tube, but presently having single fallopian tube with the hope of conception. Since about a decade, she was treatment for her infertility from various hospitals. In mid 1999, she approached the OP-Dr.Kochar, knowing her as a senior consultant in the field of IVF. The patient was initially examined by OP and accordingly advised for IVF as a most appropriate mode of treatment. The treating doctor gave fitness for IVF afterpre- IVF assessment by way of laboratory investigations and the ovulation study by ultrasonography. Accordingly the IVF was scheduled on 16-18.8.1999. Regarding the sample collection at Gaur’s lab for SST tests the complainant has not placed any cogent evidence to prove that the lab had no proper infrastructure. For good result of IVF, better quality of sperms and SST is essential.As the SST was satisfactory, the IVF was performed at Gangaram Hospital by OP on 16.8.1999 and the ET was done on 18.8.1999. The prescription or discharge summery does not show evidence of any infection. The advise for Tab Augmentin, which the treating doctor followed the routine procedure to avoid risk of future infection. It was for prophylactic purpose. Therefore, the complaint’s allegation is not sustainable.

  • The husband of patient also alleged about the variation of sperm counts; but it is a common physiological variation. The normal sperm count as per WHO Manual is between 20-110 millions/ ml. The variation of count depends upon several factors and normal physiological variations.

  • It should be borne in mind that In vitro fertilization (IVF) is a complex series of procedures used to treat fertilityand assist with the conception of a child. Itinvolves several steps — ovulation induction, egg retrieval, sperm retrieval, fertilization and embryo transfer.T he 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 acceptIVF depends on several factors for the treatment. 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.

 9.       The medical literature clearly states that,   ET in presence of vaginal infection does not alter pregnancy rate.  The international study on Bacterial Vaginosis and past Chlamydia infection shown that, both are strongly and independently associated with tubal infertility but do not affect IVF success rates.  Even the evidence of Dr. Gaur and Dr. Kamal Bakshee proves that, there was no negligence.  We have perused the expert medical opinion from RML Hospital, New Dehi, which  has commented on the success rate of IVF. It is reproduced as below:

GOVERNMENT OF INDIA
DR. RAM MANOHAR LOHIA HOSPITAL, NEW DELHI

 

Dated: 13-05-2010

 

          Sub:     Expert opinion in complaint case No.C-01/240/252 of M/s. Ispita Seal Vs. Dr. M. Kochar.

           

                        On instruction from Registrar, State Consumer Disputes Redressal Commission, A-Block, 1st Floor, Vikas Bhawan, ITO, New Delhi, a committee was constituted by Medical Superintendent, Dr. R.M. L. Hospital, New Delhi comprising of following members for expert medical opinion in complaint case No.C-01/240/252 of Ms. Ispita Seal Vs. Dr. M. Kochar.

  1. Dr. Bani Sasrkar, Sr. Specialist

  2. Dr. B. Manjhi, Sr. Specialist

  3. Dr. Manju Kaushal, Sr. Pathologist

    The committee held its meeting on 13-05-2010 in the office of Chairperson and is of the following opinion:

          The success rate of IVF-ET as per international standard is 13.4% in women less than 35 years of age and 3.6% in women above 35 years.

          ICMR guidelines were duly followed in the case.

          The failure of IVF-ET in the present case is in confirmation with the international standard.

     

            (Dr. B. Manjhi)                                                                      (Dr. Manju Kaushal)
            Sr. Specialist                                                                                        Sr. Pathologist

 

10.     According to literature, the success rate of IVF internationally is 13.4% in women less than 35 years and 3.6% in women above 35 years. A woman’s age is the most important factor that influences the success rate of IVF procedures. The IVF success rate is highest for women between 24 and 34 as this is the period when they are at their peak fertility levels.  Table showing success rates according to age.

Age Group

IVF Success Rate

24 – 34

32.2 %

35 – 37

27.7 %

38 -39

20.8 %

40 – 42

13.6 %

43 – 44

  5.0 %

45+

  1.9 %

 

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.

11. The complainant’s allegation that OP was negligent in duty of care.  The concept of duty of care has been discussed by the  Hon’ble Supreme Court in the Laxman Balkrishna Joshi’s case [1969 SCR  (1) 206]. Court observed that,

A person who holds himself out ready to give medical  advice and treatment impliedly holds forth that he is possessed  of skill  and  knowledge for the Purpose.Such a            person when consulted by a patient, owes certain duties, namely, a               duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give, and a duty of     care in the administration of that treatment.  A breach of any of these duties gives a right of action of negligence  against him.  The medical practitioner has a discretion in choosing the  treatment which he proposes to give to the patient and such discretion is wider in cases of emergency, but, he must bring to his task a reasonable degree of skill and knowledge and  must exercise a reasonable degree of care according  to -the circumstances of each case.

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.

12.     It is known that “No cure/ no success is not  a negligence” , thus fastening the liability upon the treating doctor is unjustified. The State Commission has erred in holding  the OP liable without any cogent evidence or medical ground. Therefore, on the basis of foregoing discussion,  the order of State Commission is set aside and the instant appeal is allowed. Consequently, the complaint is dismissed.

However, there shall be no order as to cost.  

 
......................J
AJIT BHARIHOKE
PRESIDING MEMBER
......................
DR. S.M. KANTIKAR
MEMBER