State Consumer Disputes Redressal Commission
L.Rajendran vs M/S Crence Hospital on 18 August, 2015
Daily Order KERALA STATE CONSUMER DISPUTES REDRESSAL COMMISSION SISUVIHARLANE VAZHUTHACADU THIRUVANANTHAPURAM CC.NO.09/08 JUDGMENT DATED : 18.08.2015 PRESENT SRI.K.CHANDRADAS NADAR : JUDICIAL MEMBER SMT.A.RADHA : MEMBER SMT.SANTHAMMA THOMAS : MEMBER COMPLAINANT L.Rajendran, Husband of Late Jaya Rajendran Alias Jalaja Rajendran, Proprietor, M/s.Naveena Enterprises, Pattoor, Thiruvananthapuram (By Adv.Sri.M.R.Anandakuttan ) Vs OPPOSITE PARTIES 1. M/s.Credence Hospital, Institute for Women's Health and Fertility Research, Near Ulloor Bridge, Thiruvananthapuram Rep.by its Administrative Officer 2. Dr.Santhamma Mathew, Credence Hospital, Near Ulloor Bridge, Thiruvananthapuram (By Adv.Sri.V.K.Mohan kumar) JUDGMENT
SRI.K.CHANDRADAS NADAR : JUDICIAL MEMBER This is a complaint filed under section 17 of the consumer protection act. The allegations in the complaint in brief are the following. The second opposite party is the consultant chief physician in the first opposite party hospital and she claims to be an expert in the field of treatment for infertility. The complainant got married long back but there was no offspring in the wedlock. Attracted by the advertisements through different medias the complainant and his wife approached the opposite parties on the belief that they would get expert care and special treatment so that they would be able to get a child. The opposite parties were giving much importance to the special educational qualifications expert knowledge, experience and expertise of the second opposite party in the field of treatment for infertility. Both the complainant and his wife were perfectly healthy and without infirmities though they were issueless. In that circumstance, they decided to undergo treatment for infertility. Before taking decision, to subject to the treatment of opposite parties the complainant and his wife had many sittings with the second opposite party. Several tests were also done. The second opposite party was of the opinion that she would be able to treat the complainant's wife and can cure their infertility. The complainant and his wife had been under the treatment of the opposite parties for about two and half years. Both of them were strictly following the directions and advices given by the second opposite party. The complainant and his wife consulted the second opposite party as directed and they underwent many medical tests which are costly in nature. After conducting every test the second opposite party used to console the complainant and his wife and assured them that the treatment would be successful.
2. After undergoing tests and treatment for about two and half years under the supervision of the second opposite party , the complainant's wife was admitted in the hospital as an inpatient on 18.04.2006 as decided by the second opposite party. The second opposite party told that the complainant's wife must strictly observe the direction and medical procedure in order to ensure the result. Hence for necessary medical supervision and management she was admitted in the hospital. The second opposite party advised them to undergo treatment procedure by name I.V.F.since it was the most scientific and effective treatment for infertility. With full faith and expectation the complainant's wife has undergone the I.V.F treatment procedure as prescribed under the supervision and management of the opposite parties. The wife of the complainant had undergone many medical tests and was administered several medicines as prescribed by the second opposite party during the so called I.V.F. treatment. On 08.05.2006 that is on the 14th day after admission as inpatient, the second opposite party advised the wife of the complainant to conduct blood test. On getting the test result the second opposite party administered the medicine by name gemstone progenova and advised the complainant's wife to take complete bed rest. Accordingly she was confined to the bed for four days. On the 4th day she was asked to move out from the bed by the paramedical staff. That was on 12.05.2006. Pulmonary embolism developed immediately and the complainant's wife breathed her last.
3. It is alleged that the second opposite party did not exercise proper care and caution in the matter of administration of such a drug and observance of post medical care, when there existed an extreme degree of duty to take care. The opposite parties were negligent in providing a standard of care expected of them which amounts to deficiency in service towards the wife of the complainant. Negligence on the part of the opposite parties both in administering the medicines and maintaining post medical care caused the death of the complainant's wife. The complainant had to spend more than Rs.2.5/- lakhs for treatment in the opposite party hospital. The intention of the opposite parties was only to squeeze money without providing proper service to the complainant. As a result of the death of the complainant he lost his partner and he is denied of matrimonial comfort consortium and avenues in life. Hence he is entitled to realize compensation. Notice dated 21.06.2006 was sent through the advocate of the complainant demanding compensation of Rs.50,00,000/-. To the notice no proper reply is sent by the opposite parties. Hence the complaint.
4. The opposite parties filed joint version. The contentions raised are that the second opposite party had not claimed that she was an expert in the field of treatment for infertility though she has special knowledge and skill in the evaluation and treatment of factors contributing to infertility in couples. The several advertisements published were not intended for profit making but as a measure to create awareness among the public about scientific breakthroughs in the field of infertility treatment so that couples if needed could utilize the treatment facilities. Before an infertile couple is accepted for treatment it is customary on the part of the opposite parties to counsel them in detail with regard to the treatment programme, the complications which can occur the possible outcome of the treatment and the expenditure estimated. Such a procedure was adopted in the case of the complainant and his wife also and they were given copy of the full information sheets a booklet on infertility and its treatment and draft copy of the agreement to be executed by the couple before accepting for the treatment programme. Semen analysis report dated 17.12.2002 from "Samad I.V.F Test Tube Baby Centre" Trivandrum showed that the semen sample of the complainant did not contain any sperm in it. As against the desirable number of sperms per millilitre prescribed by World Health Organization norms the complainant had nil sperms in his ejaculated semen. This condition is known as azoospermia. In this condition the complainant would never be able to become a father of a child by natural sexual intercourse with a woman. Similarly, the wife of the complainant also could not become a mother by natural sexual intercourse. At no point of time the opposite parties gave or made any assurance that the wife of the complainant would achieve pregnancy or give birth to a child. On the contrary, they were told that doctors can give treatment but the cure comes from God as part of the counseling given to them. It was also necessary to evaluate both husband and wife and find out the cause of infertility before deciding on the type of treatment. Before starting the treatment, apart from the male infertility factor it was necessary to assess whether the wife of the complainant was contributing to the childlessness due to ovarian factor or ovulation factor or tubal factor or uterine factor or cervical factor or antisperm secretions or diabetes, thyroid etc or emotional stress or unknown factors. In the case of the wife of the complainant she had multiple fibroids in her uterus as reported by Dr.Alex K.Ittyavirah after Trans viginal scanning (T.V.S). Fibroid in the uterus is a cause of infertility and it is generally a female infertility factor. Also she had menstrual disorders. This is known as ovulation factor. This contributed to the lack of production of eggs for fertilization. Hence the wife of the complainant also contributed to the infertility of the couple thereby making it combined causes for the infertility of the couple. Evaluation of these infertility factors could be done only with several tests at appropriate times and studying the results. After evaluating the test results the complainant and his wife were advised that their infertility was treatable by using the techniques known as I.V.F.or I.C.S.I - E.T. Invitro fertilization (I.V.F) means fertilization outside the living body. Intra cytoplasmic sperm injection (I.C.S.I) means injecting the sperm of the male into the cytoplasm of the female. Embryo transfer (E.T) is the process of transferring the embryo resulting from I.V.F into the uterus of the woman. In the case of the complainant and his wife I.V.F/ I.C.S.I/E.T was the only method of treatment for a possible pregnancy of the wife, primarily because there was no sperm in the ejaculated semen of the complainant and lack of production of eggs in the ovulation cycle of the wife .But it is false to say that the second opposite party gave confirmed opinion that she can cure the infertility of the couple. Opposite parties are selective in accepting infertile couples for treatment as detailed assessment by way of evaluation of medical history, tests, investigations etc are required to decide whether they can be accepted or not in the interest of the couples. The decision should not be taken hastily. Hence there would be several sittings for consultations and counselling. The complainant was undergoing evaluation or treatment for infertility elsewhere before coming to the opposite parties.
5. After screening the suitability of the complainant and his wife they were accepted to the treatment programme in April 2003 batch of patients. The menstrual regulation of the wife was done and response of her ovaries for producing more number of eggs was assessed by stimulating the ovaries with follicle stimulating hormones (F.S.H). However, on the fourth day of stimulation when the ovaries of the wife were scanned to evaluate the growth of eggs it was found that no egg was produced. Because of this further stimulation was stopped and treatment was cancelled. The couple was informed about the cause of their infertility as a combination of male factor and female factors. They were advised that attempt can be made to retrieve sperms directly from his testes by fine needle aspiration. If a few sperms could be retrieved from the testes, it is possible to inject the sperms into the eggs of the woman by I.C.S.I technique and embryos could be fertilized by culturing it in incubator and then transfer such embroys into the uterus of the woman. The complainant was advised clearly that testicular aspiration does not guarantee retrieval of viable sperms for reproductive purpose. They were told that if no viable sperms are retrieved the only option for them would be to accept sperms donated by another male. This is a hard decision to be taken by the infertile male because the resulting child if born would be genetically that of the donor of the sperm. In the case of the complainant also the decision would have been difficult and might have caused the lapse of 21/2 years.
6. Similarly, the ovaries of the wife were incapable of producing eggs for fertilization. The only option for her was to accept eggs from a donor. Here again the decision was entirely that of the couple which was not easy because if the wife is to deliver a baby, the baby will have the genetic qualities of the donor of the egg. The complainant and his wife agreed to make use of eggs from a donor. Then the couple was accepted into the March 2005 batch of patients. Seven eggs were accepted from a donor and were injected with viable sperms retrieved by testicular biopsy (T B X) from the testes of the husband using the intra cytoplasmic sperm injection technique. This resulted in three numbers of grade 1 embryos and these were transferred to the uterus of the complainant's wife on 30.03.2005. Test conducted for beta HCG (a hormone produced in pregnant woman which keeps on doubling every day) showed that the wife of the complainant became pregnant and thus the treatment was successful. However, the increase of beta HCG retarded showing that the pregnancy was regressing and finally the complainant's wife menstruated showing the loss of pregnancy.
7. The extreme desire and eagerness of the wife of the complainant to conceive and give birth to a child was so strong that she wanted to continue treatment by participating in the immediate possible batch of patients. Since it was necessary to give a gap of six to twelve months between to I.V.F treatment cycles, the complainant and his wife were accepted only for April 2006 batch of patients. This time eight eggs donated by a donor were injected by intra cytoplasmic sperm injection technique with sperms retrieved by testicular biopsy from the testes of the complainant on 17.04.2006. Seven of these fertilized eggs were multiplying and four grade 1 embryos were found usable. They were transferred into the uterus of the wife of the complainant on 19.04.2006.
8. The entire I.V.F treatment is done as outpatients and it is never required that the patients are admitted as inpatients. Till the end of 2006, the first opposite party hospital was carrying out the I.V.F treatment in a separate building with about 900 sq.ft area and there was no inpatient facility in the building. So it is incorrect to say that the wife of the complainant was given inpatient treatment. The fact is that the complainant never came to the first opposite party hospital or met the second opposite party after 17.04.2006. The complainant and his wife were residing at a place less than three kilometers away from the first opposite party hospital and there was no need or reason for the wife of the complainant to be available in the hospital. On 17.04.2006 the complainant was in the hospital for testicular biopsy and he left the hospital premises within half an hour after testicular biopsy. There was no need for his wife to be present on that day as the eggs fertilized using the sperm retrieved were placed in an incubator and presence of the wife was required only for transferring the viable embryos into the uterus of the woman. Any safeguard or precaution will start only after implantation of embryos into the uterus which is confirmed on the fourteenth day from the day of transfer of the embryo into the uterus of the woman. Till then the woman leads normal life like any other woman who does not need special care or caution after intercourse with the man. For acceptance of a couple for a I.V.F treatment it is mandatory to rule out diseases of the blood, liver secretions and functions, kidney functions, urine, hormonal imbalances, auto immunity, diabetes, V.D.R.L, H.I.V etc. If these tests are not done it could lead to the failure of treatment. All the tests put together for the husband and wife would cost around Rs.4000/- only. The procedure of embryo transfer takes less than five minutes and the woman is sent back within half an hour. At the time of relelase of the complainant's wife from the hospital treatment and discharge summary was handed over to her. Instructions were given to continue to take progenova tablets (estrogen hormone) and natural progesterone (gemstone 100 mg) daily for 14 days. She was also instructed to test her blood for beta HCG on the fourteenth day after embriyos transfer. On 02.05.2006 the complainant informed over phone the duty nurse in the first opposite party hospital that the beta HCG value was 23.2. As the value was more than ten on the fourteenth day after embriyo transfer, pregnancy was positive clinically. Beta - HCG test will be repeated two or three times at three or four days interval to make sure whether the pregnancy is progressing or not. The wife of the complainant was required to repeat the beta HCG test on 05.05.2006 and to continue to take progenova tablets and natural progesterone injection daily. Beta HCG level on in 05.05.2006 was 60 as reported on phone by the wife of the complainant. It indicated that the pregnancy of the complainant's wife was progressing. She was instructed to continue to take progenova tablets and natural progesterone injection and repeat beta HCG test on 08.05.2006. The beta HCG value on 08.05.2006 was 300 as verbally reported by the complainant to the duty nurse in the first opposite party hospital. He was advised that the pregnancy was progressing and to continue with progenova tablets and gemstone 500 injections to support the growth of pregnancy. This is the line of treatment given to every woman undergoing I.V.F treatment in the I.V.F centers all over the world. No contra indications in its use have been reported. The wife of the complainant was given progenova and gemstone earlier also, during her treatment period in March 2005 and there was no adverse effect. During April 2006 also no adverse effect of these drugs was reported. It is incorrect to say that 08.05.2006 was the fourteenth day after admission as inpatient. She has never been an inpatient in the first opposite party hospital. The allegation that the second opposite party administered the medicine by name "gemstone progenova" is not true. It is also incorrect to say that the complainant's wife was advised to take complete bed rest. Progenova and gemstone are not medicines which require bed rest after they are taken. It is incorrect to say that the second opposite party advised bed rest for four days for the wife of the complainant. The related allegation that she was asked to move out of bed by the paramedical staff on 12.05.2006 is untrue and false. The opposite parties are unaware of any development of pulmonary embolism to the wife of the complainant and the cause of her demise. Pulmonary embolism can happen if an injection is given by mistake or inexperience with syringe in which there is air locked or a fluid penetrating into the artery than into the muscle. Whether the person who gave injection to the wife of the complainant took precaution to avoid such contingency is not known to the opposite parties. Embolism due to intra muscular injection is as good as impossible and at any rate will not happen suddenly. The drugs were administered by a person chosen by the complainant and his wife at or near their place of residence and the competence of that person in administering injection is not known to the opposite parties. It was also possible that the person who injected the medicine was an unqualified person and could have given injection at the wrong location or sites or into the arterial blood vessel of the wife of the complainant. If that happened it could cause embolism and sudden death. There was absolutely no dereliction of duty or negligence in providing medical care or breach of duty or deficiency in service or act of omission on the part of the opposite parties. Reply was sent to the notice issued by the advocate of the complainant. The complainant is not entitled to realize compensation from the opposite parties .The complaint is frivolous and vexatious and is liable to be dismissed.
9. On the allegations in the complaint and the contentions raised by the opposite parties the main question that arises for consideration is whether deficiency in service on the part of the opposite parties is established by the complainant. If only the answer is in the affirmative, further question as to the quantum of compensation would arise.
10. The complainant gave evidence as PW1. Exts.A1 to A23 were marked on his side. Two expert witnesses were examined as the side of the complainant as PWs 2 & 3. On the side of the opposite parties two witnesses were examined as DWs 1 & 2. Exts.B1 to B8 were marked on the side of the opposite parties.
The points
11. The complainant and his wife approached the first opposite party hospital an institute for women health and fertility research as they were having no child long after their marriage on 31.01.92. The second opposite party was the consultant chief physician there and was an expert in the field of treatment for infertility. It appears that before approaching the opposite parties the complainant and his wife had undergone treatment for infertility elsewhere. They approached the opposite parties with semen analysis report of the complainant dated 17.12.2002 issued from samad I.V.F test tube baby centre, Thiruvananthapuram. Ext.B1 is the said report. It clearly shows that the sperm count of the complainant was 'nil' and thus he was suffering from the condition known as azoospermia. Thus, he was not capable of impregnating his wife. Investigations of the wife of the complainant revealed that she had multiple fibroids in her uterus. This is evident from Ext.A10 ultrasonography report from the Medical College, Thiruvananthapuram dated 21.02.2005. The impression mentioned in Ext.A10 is that the woman was having fibroid uterus. This was one of the female factors that contributed to the infertility. Ext.A15 is the transvaginal scan taken on 05, 03.2003 at the Ittyavirah Scan & Genetic Research Centre, Thiruvananthapuram. This scan had also revealed anteverted bulky uterus measuring 9.5 cms in length and multiple fibroids each measuring between 1.5 cms and 3.5 cms in size in both anterior and posterior uterine walls. Endometrial thickness measured 7 mm. Both ovaries were normal without any cyst or mass.
12. Several investigations were done at the first opposite party hospital also. Exts. A1, A4, A5 to A7, A9, A11, A13, A14, A16 to A19 & A20 are either investigation results or receipts evidencing payment for investigations. The definite contention of the opposite parties is that administration of follicle stimulating hormone did not yield the desired result of producing viable ovum. Thus the wife of the complainant was incapable of producing an offspring with her own genetic characters. It was in the above background the opposite parties advised the complainant and his wife to opt I.V.F /I.C.S.I - E.T treatment .This involved retrieval of sperms from the testes of the husband / the complainant by testicular biopsy and injection of the sperm into the ovum using cytoplasmic sperm injection technique. In the case of the complainant's wife as she was unable to produce viable ovum, the only option was to inject the viable sperms into the ovum of a donor. Thereafter, the successfully fertilized eggs will have be transferred into the uterus of the wife by a process known as embryo transfer. In order to accept the embryo, since the wife was not menstruating in a normal way, the uterus had to be prepared by prescribing appropriate medicines. It was for undergoing such a treatment the complainant and his wife voluntarily opted. Exts. B5 to B7 show that every aspect of this process or treatment for infertility were explained to the complainant and his wife and their signatures were obtained on these documents before proceeding with the infertility treatment.
13. In a healthy woman, the menstrual cycle as well as the reproductive functions are regulated by hormones like oestrogen and progesterone secreted by the reproductive organs and there is a well defined cycle resulting in conception and gestation. Normally, menstruation cycle would last for 28 days. The ovulation would happen from either ovary approximately around the middle of the cycle. If there is no fertilization of the ovum and consequent failure of implantation of the embriyo the fresh cycle begins on the 28th day when the endometrium disintegrates. Fresh endometrium would be formed and would attain hypertrophy during the middle of the cycle and by that time ovulation would take place. If a male sperm successfully fertilizes the ovum and an embriyo is developed it gets inplanted in the hypertrophied endometrium. Then the secretion of progesterone happens to sustain the pregnancy. In a normal healthy woman, no medication or external interference is required to achieve the results. In the case of couples like the complainant and his wife when there are male as well as female factors contributing to infertility by artificial injection of oestrogen and progesterone the whole cycle will have to be regulated and sustained. It was only for that purpose the opposite parties prescribed progenova and gemstone and there is no allegation even that these are not medicines prescribed world wide by medical centers treating couples for infertility using I.V.F, I.C.S,I- E.T procedure . Administration of progenova and gemstone is unavoidable to prepare the woman for receiving the embryo produced in the laboratory using the sperm retrieved from the testes of the complainant using testicular biopsy. The entire process involves continuous monitoring of the uterus to see whether it is prepared to accept the embryo cultured in the laboratory conditions and to sustain the pregnancy. These aspects are mentioned in detail because the complainant has a grievance that several investigations were unnecessarily done by the opposite parties. The complainant has also the grievance that he was attracted by several advertisements published in various media by the opposite parties. The opposite parties have explained that the advertisements were made for informing the general public regarding the advances made in the matter of treatment for infertility of couples. Whatever that be the advertisements themselves are not produced in evidence and even if produced in evidence are not sufficient say whether there was deficiency in treatment on the part of the opposite parties.
14. There is no dispute that the complainant and his wife opted to undergo I.V.F /I.C.S.I- E.T treatment. As mentioned already the documentary evidence shows that they voluntarily opted to undergo the procedure. There is no case to the contrary set up by the complainant. At any rate full co-operation of the couple is necessary for the successful implementation of the treatment process. It was accordingly the couple were accepted for I.V.F / I.C.S.I- ET programme along with March 2005 batch of patients. Seven eggs accepted from a donor were fertilized using viable sperms retrieved by testicular biopsy from the testes of the complainant using the intra cyctoplasmic injection technique. Three grade one embryos were produced and were transferred to the uterus of the wife of the complainant. Subsequent tests revealed that the woman successfully became pregnant but gradually the pregnancy regressed and finally she menstruated signalling the failure of the pregnancy. The complainant and his wife were insistent to continue the programme but since a gap of six to twelve months was required between two I.V.F treatment cycles, the complainant and his wife were accepted for I.V.F treatment only along with April 2006 batch of patients. At this time, eight eggs received from a donor were fertilized using the same process and four grade one embryos that resulted from the process were transferred to the uterus of the complainant's wife. According to the opposite parties, though for a while they were told that pregnancy was progressing the complainant and his wife never came to the first opposite party hospital or went to the second opposite party after 19.04.2006, the date on which the embryo transfer was made.
15. The main grievance alleged in the complaint is that the second opposite party did not exercise proper care and caution in the matter of administration of gemstone and progenova and failed to give proper post medical care and as a result the woman died on 12.05.2006. It may be mentioned that gemstone and progenova are intended to supply oestrogen and progesterone which are required to prepare the uterus for implantation and for sustenance of the pregnancy. The definite allegation in the complaint is that the wife of the complainant was admitted in the hospital as an inpatient on 18.04.2006 as desired by the second opposite party. After administering the medicines on 08.05.2006, the wife of the complainant was asked to take bed rest for four days in the hospital. On the fourth day the paramedical staff of the hospital asked her to move out from the bed. That was on 12.05.2006. Then suddenly pulmonary embolism developed and the wife breathed her last. The definite contention of the opposite parties is that in 2006 there was no facility for inpatient treatment in the first opposite party hospital and the complainant's wife was never an inpatient in the first opposite party hospital. The deposition of PW1, the complainant himself runs counter to the allegations in the complaint. Ext.A23, the death certificate produced by the complainant shows that the date of death of his wife was on 11.05.2006 and not on 12.05.2006. That apart PW1 deposed that on the date of death at about 1.30 p.m he was present along with his wife. She was having suffocation feeling. They had lunch together and she collapsed .He took her to the General Hospital and she was pronounced "brought dead". He further deposed that an injection of the medicine prescribed by opposite party no.2 was given by a nurse from Upasana clinic, pettah on the date of death. He also admitted that he arranged the nurse from Upasana clinic to administer the medicine. His case appears to be that the medicine was procured from the opposite parties. Though he does not remember the date of second embryo transfer he admitted that his wife did not go to the hospital after that. These admissions clearly show that the wife of the complainant was not an inpatient in the first opposite party hospital when the death actually happened. Ext.A23 death certificate issued by the corporation of Thiruvananthapuram also mentions the place of death as the house of the complainant. PW1 admitted that based on the fist information furnished by his brother in law, the Vanchiyoor police registered Crime No.107/2006. The first information statement was furnished on 15.05.2006. As per the first information statement when the sister of the first informant and her husband the complainant were sitting in their house, she felt suffocation. Immediately the complainant took her in his car parked near the house to the General Hospital and the doctors there pronounced that she was dead. As per the first information statement, some nurse working under the second opposite party used to inject the daily medicines at the residence of the complainant. On that day also, a nurse had injected medicines by about 11.am.This was informed to him by the complainant and his wife. But this version is in variance with the version of PW1 that he had arranged a nurse from Upasana Hospital to administer the medicine. Ext.B1 is the copy of FIR and FIS prepared by the Vanchiyoor police.
16. The above evidence runs counter to the definite allegation in the complaint that pulmonary embolism developed and consequent death of the wife of the complainant happened as a result of wrong advice given to take bed rest and the act of the paramedical staff in directing the woman abruptly to move out from bed and walk. But Ext.A2 copy of the postmortem report gives the cause of death of the woman as pulmonary embolism. So the main question that remains to be considered is whether pulmonary embolism which was the cause of death of woman developed as a result of any error in treatment or deficiency in service on the part of the opposite parties. In this regard the evidence of PWs 2 & 3 becomes relevant.
17. PW2 explained that when some blood clot occurs in deep veins it is called D.V.T (Deep Vein thrombosis). Usually D.V.T occurs in Lower limbs. When this blood clot gets dislocated and ultimately reaches the pulmonary vein, pulmonary embolism would occur. PWs 2 & 3 are examined to prove that D.V.T as the cause of pulmonary embolism developed as a result of administration of the wrong drug as well as lack of post medical care. Both PWs 2 & 3 explained the circumstances under which D.V.T can develop. The circumstances include medical conditions, diabetes, high cholesterol, varicose vein, prolonged immobilization, prolonged travel and in women it can occur during pregnancy. According to PW2 progenova can cause D.V.T as it is a hormone oestrogen containing medicine. PW2 further deposed that D.V.T cannot be completely prevented. But some precautions can be taken to reduce its occurrence like avoidance of prolonged stay in bed, moving the toes and fingers, frequently, compression bandage and early identification and treatment. PW2 further explained that identification of D.V.T is based on symptoms and signs. Further D.V.T occurs over a period of time. But complications in the patient can occur suddenly if the patient gets out from the bed and walks. If a doctor is seeing a patient every day he can anticipate the development of D.V.T and also by the medical condition of the patient it can be anticipated during hormone treatment also. A doctor can anticipate the development of D.V.T. and the symptoms of D.V.T are pain redness swelling and inability to walk. The remedial measures would be to lyse the clot by giving medicines and that is an intensive care procedure and sometimes surgery would be needed. Generally, doctors do not advice bed rest for patients undergoing hormone treatment except when precautionary reasons are there for advising bed rest. But PW2 is a paediatric physician and he had not treated any gynecology patient. Progenova is used to facilitate ovulation and implantation as part of infertility treatment. PW2 is not a specialist. In order to say whether pulmonary embolism is or is not a consequence of I.V.F treatment she had to consult an I.V.F expert. According to PW2 pulmonary embolism can develop if air enters into the blood stream. This suggestion is put on behalf of the opposite parties in tune with their defence that air might have entered the blood stream when inexperienced nurses might have administered the drug. Though PW2 answered in the affirmative then the condition that develops is air embolism and sufficient quantity of air must enter into the blood stream. PW2 admitted that a gynaecologist in the field of I.V.F treatment is more competent to give authoritative opinion on the risk factors of administering progenova.
18. PW3 was an additional professor in the SAT hospital and in charge of the infertility unit there when she deposed before this commission. According to her some persons may be predisposed to have .D.V.T .In such individuals progenova can lead to D.V.T. It is difficult to say the exact risk of developing D.V.T. as different population and different individuals have varying risk factors. There are certain accrued factors like bed rest or use of medicines which cause D.V.T. Often D.V.T cannot be prevented. When a patient complains of pain in the lower limbs or shows other symptoms, the patient can be examined to see whether there is D.V.T but D.V.T can occur without symptoms also. Generally light exercises can be advised but it depends on the condition of the patient also. According to PW3 D.V.T will occur with bed rest only if there are predisposing factors. D.V.T is a very rare complication and usually a doctor will recognize it only if there are symptoms. Otherwise US.S scanning will have to be done daily which is not recommended anywhere. A doctor is duty bound to have random check up regarding the development D.V.T but only by chemical examination. But many times D.V.T can occur without any symptoms or signs that is silent D.V.T can develop. D.V.T as such will not cause death but it causes pulmonary embolism and then death can occur. D.V.T is one of the causes of pulmonary embolism. Silent D.V.T and silent pulmonary embolism are both reported and common. Progenova does not cause joint pain. A patient requires strict medical supervision if only D.V.T is diagnosed and in many cases D.V.T may not be clinically evident. If D.V.T occurs with progenova it is only with very long term treatment for years. Progenova is oestrogen a hormone already present in the human being. Oestrogen is present in many other drugs including the contraceptive pill Mala D which is supplied by the Government to all Government Hospitals free of cost. In I.V.F, the treatment is for short term for a maximum period of three months. During cross examination PW3 was shown Ext.A3 prescription and she affirmed that none of the drugs mentioned therein have side effects. She explained that if air enters the blood stream what is likely to develop is air embolism and that would not be called as pulmonary embolism. During I.V.F treatment there is no necessity for hospital admission and ordinarily no bed rest is necessary. But some doctors advise bed rest and there is nothing unusual in it. During I.V.F treatment the only restriction is from doing heavy work. PW3 reiterated the view of PW2 that if silent pulmonary embolism develops it cannot be diagnosed early. Pulmonary embolism can develop at any time and if D.V.T is silent it cannot be diagnosed or prevented. PW3 was of the opinion that from the records perused by her, she could not say that there was negligence on the part of the opposite parties and according to her correct treatment was provided by the opposite parties. During re-examination she explained that D.V.T can develop after administering progenova and bed rest is advised only if there is pre deposition and this is of rare occurrence.
19. DW2 who is a consultant in an infertility clinic deposed that in the case of I.V.F treatment instances of pulmonary embolism developing will be one in ten thousand cases.
20. So the case attempted to be set up by the complainant is that wrong advice of the opposite parties in prescribing bed rest after administering progenova and the instruction of the staff of the hospital abruptly to walk induced D.V.T and consequent pulmonary embolism in the patient causing her death. While discussing the oral evidence of PW1 We have pointed out that his version in any way does not support this case alleged and attempted to be developed. His evidence clearly indicates that the deceased was never an inpatient in the hospital of the opposite parties. The death occurred while she was at the residence of the complainant and probably she never took bed rest. Oestrogen which is the component of progenova is a harmone naturally produced in the ovaries of the female. It is administered only when there is deficit production of oestrogon to regulate the reproductive cycle. So administration of this medicine is the accepted treatment procedure to correct infertility problems. Not only the opposite parties any other doctor treating similar problems would have administered only this medicine. Several factors influence the development of D.V.T and consequent pulmonary embolism including the pre disposition of the patient and the evidence is that often silent D.V.T and silent pulmonary embolism can develop. So on an appreciation of the entire evidence available we have no hesitation to hold that the complainant has miserably failed to establish that there was any deficiency in service or error in treating the wife of the complainant. So the complaint should fail. As a consequence, it is unnecessary to consider the quantum of compensation that the complainant is entitled to claim.
In the result, the complaint is dismissed but without costs.
K.CHANDRADAS NADAR : JUDICIAL MEMBER
A.RADHA : MEMBER
SANTHAMMA THOMAS : MEMBER
Be/
APPENDIX
List of witnesses for the complainant
PW1 - L.Rajendran,
PW2 - Dr.Elixabeth.K.E
PW3 - Dr.Sheela Balakrishnan
List of documents for the complainant
Ext.A1 - Doctors Diagnostic Hormones Report
Ext.A2 - Post mortem certificate
Ext.A3 - Tablet paper from Credence Hospital
Ext.A4 - Bill from Crdence Hospital datd 23.03.2006
Ext A5 - Medication cost paper
Ext.A6 - Bill from Credence Diagnostics
Ext.A7 - Test for FSH & Testosterone from Doctors Diagnostic
and Research Centre
Ext.A8 - OP ticket from Credence Hospital
Ext.A9 - Bill from Crdence Hospital datd 23.03.2006
Ext.A10 - Ultrasonography report dated 21.02.2005
Ext.A11 - Test for FSH, Estradiol & TSH from Doctors Diagnostic
and Research Centre
Ext.A12 - Investigations report from Credence Diagnostics
dated 24.02.03
Ext.A13 - Investigations report from Credence Diagnostics
dated 21.02.2005
Ext.A14 - Bill from Crdence Hospital datd 21.02.2005
Ext.A15 - Ultrasonography report dated 05.03.2003 from Ittyavirah
Scan & Genetic Research
Ext.A16 - Test Description from Metro Polis Clinical Laboratories
Ext.A17 - Test Description from Metro Polis Clinical Laboratories
Ext.A18 - Investigation report from Doctors Diagnostic & Research
Centre
Ext.A19 - Test result for RBS, Plasma from Doctors Diagnostic &
Research Centre
Ext.A20 - Bill dated 11.04.2003 from Doctors Diagnostic &
Research Centre
Ext.A21 - Advocate letter to M/s.Credence Hospital
Ext.A22 - Acknowledgment card
Ext.A23 - Death Certificate
List of witnesses for the opposite party
DW1 - Asoka kumar
DW2 - Dr.K.Jayakrishnan
List of documents for the opposite party
Ext.B1 - Copy of semen analysis report from SAMAD Hospital
Ext.B1 (a) - Copy of First Information Report
Ext.B2 - Case history of credence hospital
Ext.B3 - Copy of investigation report dated 21.02.2015
Ext.B4 - Copy of investigation report dated 21.02.2015
ExtB5 - Copy of letter
Ext.B6 - Copy of information for couples opting for IVF report
Ext.B7 - Copy of agreement
Ext.B8 - Copy of ovulation profile
K.CHANDRADAS NADAR : JUDICIAL MEMBER
A.RADHA : MEMBER
SANTHAMMA THOMAS : MEMBER
Be/
KERALA STATE
CONSUMER DISPUTES
REDRESSAL COMMISSION
SISUVIHARLANE
VAZHUTHACADU
THIRUVANANTHAPURAM
CC.NO.09/08
JUDGMENT DATED : 18.08.2015
Be/