M.Mageswari v. Dr. Chitra, MD, DGO,

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Prepared by Tmt. S. Tamil Selvi B.A., B.L., President

1. The complaint filed under section 35 of Consumer Protection Act, 2019 for the relief to return the Medical Expenses incurred by the complainant Rs. 5,00,000 with interest and for compensation of Rs. 25,00,000/- for deficiency of service, mental agony and inconvenience caused to the complainant and for the cost of the litigation by the opposite party.

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2. The brief facts of the complaint: The Complainant States that the opposite party is running fertility centre, under the name and style JANANI Trichy Fertility Centre at Trichy. The Complainant and her husband even after twelve years of their marriage, is not blessed with any child, initially approached to test themselves for procreation of children at Ariyalur hospital and undertaken treatment for infertility and she had failed Intra Uterine Insemination (IUI), three times. Thereafter the complainant approached the opposite party at Lalitha Nursing home on 27.09.2022 as outpatient. The Complainant trusted the words of the opposite party under gone treatment with the opposite party. The opposite party also prescribed some blood and semen test. The complainant and her husband met the opposite party on 03.10.2022 with test results. After perusing the report, the opposite party, simply represented the complainant, that the previous method failed, hence opposite party suggested alternative method. The complainant states that on 01.11.2022 without explain anything, the opposite party obtained signatures from the complainant. The opposite party again asked the complainant to come on 15.11.2022 when the complainant went to Janani centre, and the opposite party simply said that the complainant must coming on 16.12.2022 without fail, after some diagnosis, requested the Complainant on 31.12.2022. On the day the opposite party took the complaint to operation theatre and performed some insertions, after giving anaesthesia and asked the complainant to cautions on her regular routine and asked the complainant to come on 14.01.2023, when the complainant went to Janani Centre, after blood test, the opposite party informed that the result was negative. The complainant listed the negligent act of the opposite party which are the freezing of eggs taken from the complainant and sperm of the husband for future use without the consent of the parties, the non advise to keep some obedience before taking semen test which affects the semen sample, the opposite party never showed any report to complainant from the very beginning etc. The complainant states that due to the care less manner of treatment from the very beginning of the opposite party caused failure in the ICSI process. The complainant had issued an advocate notice to opposite party on 10.04.2023 for which the opposite party issued a false reply on 25.04.2023. Hence the complainant filed this complaint.

3. The written version of opposite party: The Complainant Mrs. Maheshwari, 34 years old female came and met the opposite party. First at Lalitha Nursing Home in 27.09.2022 with history of infertility. The opposite party came to know that before meeting the opposite party the complainant had undertaken treatment for infertility elsewhere and showed the reports stating that

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she had failed Intra Uterine Insemination (IUI) three times. To treat the complainant USG was done on 27.09.2022 and blood test including Thyroid Hormone Test, Anti Mularian Hormone(AMH) for the complainant and semen analysis, DNA fragmentation test and Thyroid Test for the complainant's husband were ordered to be done. The complainant again came and met the opposite party on 03.10.2022 at Lalitha Nursing Home with investigation reports. Husband's semen analysis, It was explained to them that sperm motility was low and DNS fragmentation index was high. AMH of the complainant was 3.02 which was satisfactory. ICSI was considered as In Vitro Fertilization (IVF) due to high DFI and the rate of fertilization would be better in ICSI than IVF. The couple were explained in detail about the treatment, the cost involved and the percentage of success in the treatment. On 01.11.2022 Ultra Sonogram (USG) ovulation stimulation was started. On 12.11.2023 Complainant was admitted for day care OOCYTE pickup procedure at JANANI under anaesthesia, ovum pickup was done in a sterile operation theatre under aseptic precaution. After completing the procedure of ovum pick up, the complainant was shifted to ward and observed for 4 hours. It was explained to them that totally 12 oocytes were retrieved out of which only 3 eggs were matured 9 eggs were immature. The semen was washed and prepared for ICSI and ICSI was done on 15.11.2022, 3 embryos of grade B were obtained. The complainant and her husband were informed about the quality of embryos and success rate. As it was not satisfactory with drawal bleed with Regestrone tablet were given. The complainant was advised to come one day after her subsequent menstruation cycle to evaluate her and prepare her endometrium for embryo transfer (ET). Endometrium growth was monitored serially by USG. It is submitted that clear instructions were given to complainant to follow the Luteal support drugs and to come on 14.01.2023 for BETA HCG. The blood sample of the complainant tested on 14.01.2023 was negative and no pregnancy was achieved. All the test reports from the first day of consultation till date of ICSI procedure are discussed and handed over to the patient then and there. No relief of success in procedure does not imply medical negligence. The opposite party had not committed any negligence in treating the complainant nor any deficiency in service occur in the service while treating the complainant. The opposite party prayed to dismiss the complaint with exemplary cost.

5. To establish the claim of the complainant, the proof affidavit of complainant has been filed and recorded as PW1 and marked four documents as Exs.A1 to

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A4 in support of the complaint. The opposite party filed proof affidavit as RW1 and marked one document as Exs.B1 in support of their defense.

6. THE POINTS FOR CONSIDERATION ARE:

1) Whether the opposite party committed deficiency of service to the Complainant?

2) What are the reliefs to which the complainant is entitled for?

7. POINT NO. 1: The complainant and her husband namely Muthusamy have not been blessed with the child even after 12 years of their marriage. The complainant had past history for taking treatment for infertility through IUI (Intra Uterine Insemination) and the same were failed three times. The opposite party is running fertility centre, under the name and style of JANANI TRICHY FERTILITY CENTRE at Trichy. The complainant visited the opposite party at her clinic Lalitha Nursing Home on 27.09.2022 as an out-patient for consultation regarding her issue of infertility. On that date the opposite party took investigations on the complainant and her husband and treated the complainant as outpatient and also prescribed some blood and semen test. The complainant and her husband undergone the test and met the opposite party with their reports on 03.10.2022at Lalitha Nursing home. Until this all the facts are admitted by both the parties.

8. In this juncture it is averred by the complainant that that after perusing the report, the opposite party had not disclosed the fact that the infertility is due to the complainant or of her husband, simply suggested alternative method of fertilization without any discussion with the complainant. It is also averred by the complainant that the complainant and her husband were not aware of the method of fertilization and was not explained by the opposite party, but promised by this treatment the complainant would surely get a child and there is no chance of failure. It is also averred by the complainant that the complainant did not understand about the treatment and co-operate completely with the opposite party for the success of treatment. It is also averred by the complainant that on 01.11.2022 the complainant and her husband were taken to Janani fertility centre, the opposite party and their teammates discussed with themselves and obtained signatures in printed forms from the complainant without expressing anything. It is also averred by the complainant that the opposite party again asked the complainant to come on 15.11.2022 when the complainant went to

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Janani centre, and the opposite party simply said that the complainant must come on 16.12.2022 without fail, after some diagnosis, requested the complainant on 31.12.2022 on the day the opposite party took the complainant operation theatre and performed some insertions, after giving anaesthesia and asked the complainant to cautious on her regular routine and asked the complainant to come on 14.01.2023, when the complainant went to Janani centre, after blood test, the opposite party informed that the result was negative.

9. Per contra the opposite party contended that the opposite party never assured or promised the complainant that she would definitely bore a child and on the other hand, the opposite party intimated the complainant and her husband that she can only provide the proper treatment. The treatment and procedure adopted by the opposite party were explained in the averments as follows.On 28.09.2022 complainant's husband had a semen analysis which showed normal count, normal morphology but decreased forward motility of the sperms (ASTHENOZOOSPERMIA).Semen function test VIZ. SPERM DNA

FRAGMENTATION INDEX was also done. DNA fragmentation index was 74.4% (More than 30 is considered low fertility potential). The complainant was tested to assess her ovarian reserve with ANTI MULLERIAN HORMONE which was 3.02 ng/ml. This report suggests that her fertility potential would be SATISFACTORY. In view of her age (34 years) and married life of 12 years with failed IUI outside for 3 times and plan of treatment was ART (Assisted Reproductive Technology). In addition, semen analysis report showed Asthenozoospermia and DFI 74.4% preferred mode of treatment was considered ICSI (Intra Cytoplasmic Sperm Injection).All the test reports were explained in detail and discussed. The opposite party explained in detail the complainant and her husband about the treatment, cost involved and percentage of success regarding ART (ICSI).Having understood the various aspects of the Test reports, course of treatment, cost involved, and the success rate the couple expressed their willingness to the undergo the treatment. Hence the complainant was asked to come to JANANI for initiating ICSI treatment. On 01.11.2022 the complainant and her husband came to Janani Trichy Fertility Centre. This opposite party along with Dr.B. Ananthalakshmi, a ESHRE Certified Clinical Embryologist, who is a senior Doctor explained in detail the procedures to be adopted and asked the complainant and her husband to execute the necessary documents in support of their consent. Only after detailed explanations the complainant and her husband with full knowledge confirmed, agreed and expressed their willingness to undergo treatment irrespective of the result, but with positive hope, and executed the

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necessary forms. Tests were conducted on 12.11.2022 and ICSI was performed on 31.12.2022. Before 31.12.2022 the complainant was periodically checked and necessary prescriptions were also given and each and every time all procedures and protocols were explained in detail to the complainant and her husband. After the main procedures also, the complainant was advised to be cautious and her health was monitored. Finally, after the required period on 14.01.2023 test was conducted upon the complainant as fixed on 31.12.2022 and the test result was found to be negative.

10. The ICSI and IVF treatments are the form of ART (Assisted Reproductive technique) adopted to treat the infertility of the patient. The ICSI is the form of IVF treatment. ART refers to lab-based fertility treatments that use Oocyte and sperm outside of the human body to start conception. In ICSI-IVF where a single sperm is injected into single egg, implants the fertilized egg (embryo) into the female uterus. On perusal of the above averments of the complainant and the opposite party, it reveals that the clinical procedure adopted and treatment given by the opposite party were not in question. Hence it is decided that obtaining an expert opinion on the clinical procedure and treatment given by the opposite party was not necessitated in this case. The very contention of the complainant is that the opposite party was not fully informed and discussed every facts, choices and preferences available to the complainant in the Assisted Reproductive Technology, which are having direct influence on the very decision making process. The complainant also contended that without discussed anything with the complainant and her husband, the opposite party after perusal of the test reports, semen analysis report, considering the age factor (34 years of her age), married life of 12 years and past history of three times failure of IUI treatment, made a suggestion to the complainant for ICSI treatment. The procedure and treatment adopted by the opposite party were supported by the documentary evidence Ex. A1 and Ex. B1 medical records of the complainant. The suggestion made by the opposite party based on the above reason was not of course procedurally seems to be the medical negligence on part of the opposite party.

11. It is averred by the complainant that as per the medical ethics on fertility, the patients should be under opposite party's care and protection to avoid unnecessary complications and miscarriage at the time of conception which was carelessly handled by the opposite party; when the eggs were taken from complainant and fertilized with her husband's sperm, freeze it for future use for the same patient a tortuous act attracts negligence; the non-reference of

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complainant's husband to any male doctor to undergo any potency test and semen test is against the medical ethics and a proved negligent on the part of opposite party; during process of ICSI treatment, the couples are not advised to keep some obedience which was mandatory advice; before taking semen for test, the non-ascertainment of doctor and lab-technician that the male partner had any intercourse just before five days of the semen test, which affects the semen sample; before the implantation of the eggs, particularly when the date was fixed for transfer of embryo it is mandatory to refer to endometrial test under ultrasonography, to satisfy the thickness of the endometrial to bear the weight of the transfer and after its growth are listed as negligent act of the opposite party to the complainant.

12. Per contra it is contended by the opposite party that on 12.11.2022 the day of Oocyte retrieval, the Complainant and her husband were informed that three fertilizable matured Oocytes were retrieved and the appearance of the Oocytes was also not good as all of them had central cyto plasmic pitting was explained and report was given and detailed embryology summary report was handed over to the couple stating in detail about Oocyte, semen quality, number of embryos and their grade stating that the embryos are frozen. It is further contended that it is customary to assess progesterone hormone level on the day of ovulation trigger, in this case the level was 1.2 ng/ml. When transfer of embryos is done if the value is equal to more than 1.2 ng/ml the chance of achieving a pregnancy is poor. So, fresh embryo transfer was deferred, and frozen embryo was planned and same was explained to the couple and embryos were frozen and the same was stated in the summary handed over to the complainant. It is further contended that referring the complainant's husband to a male doctor to undergo any potency test was not necessitated as the complainant's examination revealed no difficulty in intercourse and further the treatment of choice offered was ICSI where test for potency is not at all applicable. Further it is contended by the opposite party that Oocyte pickup is done by trans vaginal route, to avoid vaginal infection the opposite party had advised abstinence till the procedure and there are no recommendations regarding specific abstinence in literature. Further it is contended by the opposite party that on 16.12.22, day two of the menstrual cycle, the complainant was seen by the opposite party, USG was done and the USG examination revealed thin endometrial growth corresponding to Second day of cycle and drugs (estrogen) were given to promote endometrial growth to check the endometrium, the patient was called on day 9 (23.12.22) of the cycle and Endometrial thickness measurement and the pattern were noted by ultrasound

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and the complainant was reviewed on day 12 (26.12.22) and on day 14 (28.12.22) to review the endometrial thickness and pattern by ultrasound and on day 14, as it was satisfactory (endometrial thickness 0.82 cm, trilaminar in pattern with sub endometrial flow present.) and progesterone hormone was tested which was 0.8 mg/ml, It was decided to go ahead with frozen embryo transfer, three days after progesterone injection and the same were noted in the JANANI OPD chart and handed over to the patient after explaining the details and on 31.12.2022 embryo transfer was done in the operation theatre under aseptic precaution without anaesthesia. As far as the above instance of negligence enumerated by the complainant was properly explained by the opposite party and the explanation were substantiated through the documents Ex. A1 and Ex. B1 medical reports. Hence it is presumed that the above list of negligence act of opposite party enumerated by the complainant are not supported with any scientific reasons and not proved to be negligent act of the opposite party. It is decided that the failure to achieve fertility of the complainant was not considered to be medical negligence on part of opposite party.

13. It is averred by the complainant that during the procedure and after perusing the test reports of the complainant and her husband, every option found in the ICSI treatment was not fully explained. Moreover, it is averred by the complainant that the couples are prolongingly waiting for the child and they already failed 3 times in IUI fertility treatment and spent more time and money in the process. On perusal of consent for Oocyte retrieval and embryo transfer form filed along with Ex. B1, it is presumed that four types of mixing of Oocyte and sperm using ART procedures were provided. They are 1). Complainant's Oocyte & the sperm of husband, 2). Complainants Oocyte & Anonymous donor sperm, 3). Anonymous donor Oocyte & sperm of complainant's husband and 4). Anonymous donor Oocyte & Anonymous donor sperm. It is inferred that only the 1^stcombination was informed by the opposite party to the complainant and her husband. Nowhere in the pleadings, evidence and written argument of the opposite party it is proved that the opposite party informed the combination of mixing of Oocyte and sperm to the complainant and the 2^ndto 4^thcombination of mixing were denied by the complainant and her husband. On perusal of averments of the opposite party it is inferred that during 03.10.2022 the complainant fertility potential was satisfactory and due to the DNA Fragmentation Index(DFI)was 74.4% (more than 30 is considered low fertility potential) low to poor fertility potential of the complainant's husband, the ICSI was considered to be the preferred mode of treatment by the opposite party. But

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from the averments of the opposite party, it reveals that on the date of Oocyte retrieval 12.11.2022, the opposite party came to know the appearance of the Oocyte was not good as all of them had central cytoplasmic pitting. The transfer of embryos was performed only on 31.12.2022 due to some technical reasons and meanwhile the embryo transfer was deferred and embryos were frozen. It was inferred from the Ex. A4 reply notice of the opposite party that totally12 Oocyte were retrieved; out of which only 3 eggs were matured; 9 eggs were immature; all eggs had cytoplasmic pitting; ICSI was done; on 15.11.2022 three days after ICSI, 3 embryos of grade B were obtained; the couple were counselled about the quality of the embryos and success rate and on 31.12.2022 the frozen embryo transfer was done. In this juncture it is notable that the duties of fertility hospitals provided in the Assisted Reproductive Technology (Regulation) Act, 2021, that the duty was cast upon the opposite party that the complainant must be informed of the material information's and she has the liberty to withdraw her consent at any time before transfer of embryos.

14. The relevant provisions of Assisted Reproductive Technology (Regulation) Act, 2021 are extracted as follows:

Section 21 (iii) "help the commissioning couple or woman to arrive at an informed decision on such matters that would most likely be the best for the commissioning couple" and

section 22 (4) Any of the commissioning couple may withdraw his or her consent under sub-section (1), any time before the human embryos or the gametes are transferred to the concerned woman's uterus.

15. On perusal of records, it is notable that after knowing the poor fertility chance due to central cytoplasmic pitting of the oocyte of the complainant, without counselled about the quality of embryos and success rate, the opposite party done an ICSI. If the complainant and her husband were informed about the other combination of mixing of oocyte and the sperm, after when they came to know the poor fertility ratio of their oocyte and sperm before the process of ICSI done by the opposite party, the complainant and her husband may be opted for other options. In case the complainant and her husband were fully informed about the other combination of mixing of oocyte and the sperm by the opposite party, at the time of obtaining the initial consent for treatment or at least, after oocyte retrieval and before ICSI done, the choice, preference and decisions of complainant may vary. Hence it is presumed that the very consent of the

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complainant for treatment was obtained without providing the full material information as contemplated under the provisions of Assisted Reproductive Technology (Regulation) Act, 2021. The withholding of material information invalidates the vital ingredient of free consent which was the very basis of the formation of the contract. Hence it is decided that by not providing full information regarding her choices and preferences, influenced the decision making of the complainant based on limited information, obtained a consent and made the complainant to suffer monetarily, physically and emotionally and thereby the opposite party committed unfair trade practice and deficiency of service to the complainant. Point No. 1 is answered infavour of the complainant.

16. POINT NO.2: On perusal of Ex.A2 it reveals that the amount of Rs. 75,000/- paid via g pay was wrongly added and it is established through medical bills that the complainant spent Rs.1,61,160/- for her treatment. Hence it is decided that the complainant is entitled for the reimbursement of the medical expenses of Rs.1,61,160/- from the opposite party. The opposite party has committed unfair trade practise and deficiency in service to the complainant which would have naturally caused mental agony and inconvenience to the complainant for which he is entitled to compensation from the opposite parties. And the complainant is entitled for the litigation cost.

In the result, this complaint is allowed and it is ordered that the opposite party is liable to reimburse the medical bills of Rs.1,61,160/- spent by the complainant and to pay compensation of Rs. 60,000/- (Rupees Sixty Thousand only) for the mental agony, deficiency of service and inconvenience caused to the complainant. Time for compliance of the order is one month from the date of this order, failing which the above awarded amount will attract interest @ 12% p.a. thereafter till realization. The complainant is entitled to get the litigation cost of Rs. 10, 000/- (Rupees Ten Thousand only) from the opposite party.

Dictated by the President to Steno-typist transcribed by her and corrected and pronounced by us this Wednesday of 20^th day of December, 2023.

MEMBER-I MEMBER-II PRESIDENT

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LIST OF WITNESSES EXAMINED ON THE SIDE OF COMPLAINANT

1 12.10.2023 PW1 Mrs. Maheswari (Complainant)

LIST OF DOCUMENTS MARKED ON THE SIDE OF THE COMPLAINANT:

S.No Date Description of the Document Remarks

Ex.A1 27.09.2022 Treatment Files of Complainant Original Ex.A2 - Medical bills of Complainant Original Ex.A3 10.04.2023 Legal Notice Office copy Ex.A4 25.04.2023 Reply Notice Original

LIST OF WITNESSES EXAMINED ON THE SIDE OF OPPOSITE PARTY

1 16.11.2023 PW1 Dr. S. Chitra (Opposite party)

LIST OF DOCUMENTS MARKED ON THE SIDE OF THE OPPOSITE PARTY:

Ex. B1 -- Medical documents of the complainant Xerox

MEMBER-I MEMBER-II PRESIDENT