National Consumer Disputes Redressal
Parveen Bano vs Dr. V. Padmavathi & 2 Ors. on 18 July, 2024
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL NO. 918 OF 2017 (Against the Order dated 21/03/2017 in Complaint No. 104/2013 of the State Commission Andhra Pradesh) 1. PARVEEN BANO W/O PANKAJ BHUVA R/O PLOT NO.52,H.NO.3-1-231 SOWBHAGYA NAGAR, LB NAGAR, HYDERABAD-500074 TELANGANA ...........Appellant(s) Versus 1. DR. V. PADMAVATHI & 2 ORS. YASHODA HOSPITAL,MALAKPET, HYDERABAD-500074 TELANGANA 2. DR. G. SURENDER RAO THE MANAGING DIRECTOR,YASHODA HOSPITAL,MALAKPET HYDERABAD TELANGANA 3. THE NEW INDIA ASSURANCE COMPANY #6-3-862/A/B,11D FLOOR,LAL BUNGLOW, GREEN ANDS,AMEERPET. HYDERBAD TELENGANA 4. - - ...........Respondent(s) FIRST APPEAL NO. 1773 OF 2017 (Against the Order dated 21/03/2017 in Complaint No. 104/2013 of the State Commission Andhra Pradesh) 1. DR. V. PADMAVATHI & ANR. YASHODHA HOSPITAL, MALAKPET. HYDERABAD. 2. THE MANAGING DIRECTOR. TASHODHA HOSPITAL, MALAKPET. HYDERABAD. ...........Appellant(s) Versus 1. PARVEEN BANO & ANR. W/O. PANKAJ BHUVA.
R/O. PLOT NO.52, H.NO.3-1-231,SOWBHAGYANAGAR, L.B. NAGAR. HYDERABAD-500074 2. THE NEW INDIA ASSURANCE CO.LTD. REP. BY ITS.SR. DIVISIONAL MANAGER.
NO.6-3-862/A/B, II FLOOR, LAL BUNGLOW, GREEN LANDS, AMEERPET. HYDERABAD ...........Respondent(s) BEFORE: HON'BLE MR. JUSTICE SUDIP AHLUWALIA,PRESIDING MEMBER HON'BLE AVM J. RAJENDRA, AVSM VSM (Retd.),MEMBER FOR THE APPELLANT : FOR PARVEEN BANO : MS. RUCHI MUNJAL, ADVOCATE MR. AMOLOK, ADVOCATE FOR THE RESPONDENT : FOR DR. V. PADMAVATHI & M.D. OF YASHODA HOSPITAL : MR. D. ABHINAV RAO, ADVOCATE MS. PRERNA ROBIN, ADVOCATE FOR NEW INDIA ASSURANCE COMPANY LTD. : MR. ASHISH VARMA, ADVOCATE Dated : 18 July 2024 ORDER AVM J. RAJENDRA, AVSM, VSM (RETD.), MEMBER
1. This Order shall decide both the Appeals arising out from the impugned Judgment /Order dated 21.03.2017 passed by the learned State Consumer Disputes Redressal Commission, Andhra Pradesh (hereinafter referred to as the "State Commission") in CC No. 104 of 2013, wherein the State Commission partly allowed the complaint.
2. For Convenience, the parties in the matter are being referred to as mentioned in the Complaint before the State Commission. Mrs. Parveen Bano is referred to as the Complainant. While Dr V Padmavathi, MD (Obs. & Gynecologist) is referred to as OP-1; the Managing Director-Yashoda Hospital is referred to as OP-2; and the New India Assurance Co. Ltd. is referred to as OP-3.
3. Brief facts of the case, as per the Complainant, are that she approached OP-1 on 22.06.2012 with medical conditions such as dysmenorrhea, and menorrhagia for the past two years and also intermittent abdominal pain. She had history of diabetes mellitus, hypothyroidism and hypertension. OP-1 suggested her to undergo Total Laparoscopic Hysterectomy (TLH) surgery. She was admitted to OP-2 Hospital on 27.06.2012. Based on certain medical tests and investigations, she was diagnosed as a case of 'uterine fibroids'. OP-2 Hospital prescribed further investigations and diagnostic tests culminating in Laparoscopic Hysterectomy. The TLH was performed by OP-1 on 27.06.2012. Soon thereafter, she began experiencing severe pain in the operated area and abdomen with blood in stools and vomiting. Despite reporting the symptoms and conditions, OP-1 did not call for further examination. Due to worsening of symptoms, a CT scan was held on 01.07.2012. It revealed injuries to the rectum and bladder during the TLH surgery leading to infection. Thereafter, OP-1 advised immediate open abdomen surgery to the Patient's husband and demanded payment of Rs.2 Lakhs. Subsequently, on 02.07.2012, an exploratory laparotomy was performed on her by Dr B Maherder Reddy and others, involving pus drainage, repair of rectal perforation, loop diversion colostomy and bilateral ureteric catheterization. She was placed in Central AMCU and ventilated for 3 days under intense antibiotics. She was later transferred to a room and was discharged on 11.07.2012 with a colostomy bag, incurring expenditure of Rs.4,75,121/-. On 14.07.2012, she was admitted to OP-2 Hospital due to abdominal pain and discharge from the wound. Despite treatment, her condition did not improve, leading to admission to Mediciti Hospital, where sub-acute intestinal obstruction was diagnosed. Following treatment and discharge on 24.07.2012, incurring medical expenses of Rs.43,000, the Patient underwent a Colostomy Closure at OP-2 hospital on 27.08.2012.
4. There were discrepancies between ultrasound findings on 22.06.2012 and discharge summary dated 12.07.2012 as regards presence of endometriosis (6 mm thickness) on abdominal organs. Supporting evidence from the report from Vijaya Diagnostic Centre on 10.02.2013 did not indicate endometriosis on abdominal organs. She suffered from indigestion, mild esophagitis, erosive pan gastritis and left lumbar region injuries due to surgeries at OP-2 hospital.
5. The Complainant issued a Legal Notice on 29.03.2013, and OPs gave evasive replies. Despite spending nearly Rs.10 Lakhs as medical expenses, there was no improvement, causing physical hardship, mental anguish, and pecuniary loss due to negligence of OP-1 and 2. Septicemia developed due to untreated infection, incurring continuous medical expenses of Rs.10 Lakhs. Hence, being aggrieved, she filed a CC No. 104 of 2013 before the State Commission, seeking Rs.10 Lakhs for medical expenses and Rs.25 Lakhs compensation for gross negligence in surgeries and others.
6. In reply before the State Commission, OP-1 and 2 vehemently and specifically denied each allegation made by the Complainant and asserted that they provided the highest standard of professional care. The Complainant visited to OP-2 hospital on 27.06.2012 with a history of 'dysmenorrhea and menorrhagia' persisting for past two years, along with intermittent abdominal pain. Notably, she had history of diabetes mellitus, hypertension, hypothyroidism and bronchial asthma, all of which were under treatment for the last three years. Additionally, she had undergone a caesarean section delivery 18 years prior and experienced secondary infertility since then. Upon ultrasound examination, multiple fibroids were detected, prompting the medical team to recommend surgery. Given her age and symptomatic profile, a decision was taken for hysterectomy, with clinical consideration of possible endometriosis despite the ultrasound findings indicating a fibroid uterus. Due to the presence of multiple fibroids, a total hysterectomy was deemed necessary. The OPs informed both the patient and her husband in detail about the potential risks and complications associated with laparoscopic hysterectomy. These included the possibility of bowel and bladder injury, which might become apparent postoperatively and necessitate further surgical intervention. Additionally, the inherent risks of anaesthesia were also discussed and explained, considering her underlying medical conditions such as diabetes mellitus type II, bronchial asthma, and hypothyroidism. Moreover, the likelihood of adhesions due to previous caesarean section and the strong clinical suspicion of endometriosis were also communicated.
7. After being fully appraised of the benefits and risks associated with laparoscopic hysterectomy, both the patient and her husband consented and signed the consent form on 27.06.2012. During the surgery, OP-1 and 2 encountered extensive endometriosis affecting the bilateral tubes, ovaries, rectum, pouch of Douglas and bowel loops, with adhesions to the uterosacral ligament. Considering the severity of endometriosis, a decision was made to perform bilateral salpingo-oophorectomy. Bowel integrity was carefully assessed under the supervision of another General Surgeon, and bladder integrity was verified by filling it with normal saline. No evident bowel or bladder injury was identified. Although cases of inadvertent organ damage occur in approximately 1 in 100 cases of extensive endometriosis, the patient initially showed signs of recovery on the first and second postoperative days, with stable vital signs. The vaginal pack was removed on the second postoperative day, revealing no active vaginal discharge, and the patient's blood sugar levels were under control. She was allowed to consume liquids on the 2nd day. However, on the 3rd postoperative day, she experienced abdominal pain and vomiting. By late afternoon, abdominal distension, increased pulse rate, and sluggish bowel sounds were observed. Thus, a consultation with a general surgeon was sought, who recommended more investigations including ultrasound and X-ray of the abdomen. The patient was initially uncooperative and eventually consented to these investigations, which returned normal results. Further examination on 01.07.2012 revealed surgical emphysema, accompanied by breathlessness and increased blood pressure. Consequently, he was transferred to acute medical care, where her condition deteriorated rapidly, prompting a laparotomy around 8.00 PM. The second operation was necessary due to the extensive endometriosis observed during the initial surgery, which involved drainage of pus, repair of rectal perforation, loop diversion colostomy and cystoscopy with bilateral ureteric catheterization. Intraoperatively, approximately 500 ml of pus and peritoneal fluid were drained and sent for culture and sensitivity testing. Extensive endometriosis spots were noted on the bowel loops, rectum, and bladder wall. A small 2x2 mm perforation was identified on the anterior wall of the recto-sigmoid junction, surrounded by dense endometriotic spots. The perforation was closed in two layers with mersilk, and a diversion loop colostomy was performed to promote optimal healing. Cystoscopy and bilateral ureteric catheterization were conducted by a Urologist to rule out bladder and ureteric injury, given the severity of endometriosis. No evident injury to the bladder or ureter was detected, and the rest of the abdominal organs and bowel were found to be normal.
8. After the surgery, she was transferred to Central Acute Medical Care (AMC) and placed on a ventilator for three days. The ventilator was removed on the fourth day. Throughout this period, her vital signs remained stable, blood sugar levels were controlled, and her temperature gradually decreased, reaching 102˚F. By the sixth postoperative day, he was permitted to consume liquids, and on the seventh day, she was transferred to a regular room and encouraged to mobilize. The catheter was removed on the ninth day, and the colostomy functioned properly. On 12.07.2012, she was afebrile, and due to her improved health condition, she was discharged from the hospital. However, she was readmitted on 14.07.2012 due to complaints of wound discharge and inability to pass urine. Upon review by the General Surgeon, she was diagnosed with paralytic ileus which was managed conservatively with Ryles tube aspiration and intravenous fluids. Additionally, due to a haemoglobin level of 8.3 MG, a blood transfusion was administered and at the patient's request, she was discharged for the second time on 21.07.2012, with instructions to follow a liquid diet for one week and to attend a follow-up appointment at the Gynae Outpatient Department on 26.07.2012. However, she did not attend the follow-up appointment.
9. OP-1 and 2 emphasized that they provided detailed explanations of the complications arising during the hysterectomy, which were duly documented in the patient's medical records. These explanations were also communicated to the patient's husband and relatives. Moreover, in response to the unforeseen condition of the patient and the unexpected financial burden faced by her, OP-2 extended a discount of Rs.65,121/- purely on humanitarian grounds. They expressed unawareness regarding the treatment provided to her at Mediciti Hospital. However, they highlighted that both OP-2 and Mediciti Hospital advised similar courses of action. They cited the discharge summary issued by Mediciti Hospital, which indicated that the increase in the Complainant's abdominal pain was attributed to consuming solid food, contrary to the advice given by the OPs to adhere to a liquid diet. The Complainant returned to OP-2 hospital on 27.08.2012 for colostomy closure, suggesting confidence in their services. The procedure was conducted by general surgeons, and the patient's post-operative period was uneventful, leading to her discharge on 02.09.2012 in good physical and mental health condition. She did not seek further follow-up with OP-1. OP-1 and 2 asserted that they exercised utmost care in managing patients with conditions such as endometriosis, fibroid uterus, previous lower segment caesarean section (LSCS), diabetes, hypertension, bronchial asthma and hypothyroidism. They closely monitored her preoperatively, intraoperatively and postoperatively, allowing early detection and management of complications, thereby minimizing morbidity. They provided statistics on known complications in general laparoscopic surgery, citing a 3.6% incidence of bowel injury and a 1 in 300 incidence of urinary tract injury, as observed in the Telende textbook. They contended that endometriosis cannot be diagnosed solely through imaging techniques and requires confirmation by clinical symptoms and visual inspection during surgery, which was conducted in this case by the Gynaecological team. The diagnosis of endometriosis was further confirmed through histopathological examination of the specimen. It was also noted that severe Grade 4 endometriosis necessitates ongoing medical management post-surgery, which she did not despite advice.
10. OP-1 and 2 emphasized that OP-1 has been an integral part of OP-2 hospital for over 12 years and actively performed laparoscopic surgeries, including approximately 700 operations, of which about 500 were laparoscopic hysterectomies. No complications arose even in high-risk patients. They contended that in the present case, any complications were promptly addressed by the OPs, ultimately saving her life. They relied on Consumer Protection Council Vs Clinic Maternity Home, Vol II 1996 CPJ 157, which highlighted the inherent risks associated with hysterectomy operations, particularly in cases of endometriosis, as affirmed by expert opinion. Therefore, they asserted that the Complainant lacked sufficient cause of action to file the complaint, as there was no negligence on their part. As regards the quantum of compensation claimed, they contended the same as illusory and unjustified. They are not obligated to pay any compensation, let alone the Rs.35 lakhs. Additionally, they noted that OP-2 was insured with OP-3, making the insurance company a proper and necessary party to the complaint. Hence, based on these reasons, the OPs prayed for the dismissal of the complaint.
11. OP-3 in their reply contended that as OP-2 hospital was insured under the Medical Establishments, Errors & Omissions Policy with OP-3, the Complainant lacked privity of contract with OP-3. Therefore, she cannot directly proceed against OP-3, and any indemnification would occur only if the claim against OP-2 becomes admissible under the policy's terms and conditions. OP-3 clarified that it would reimburse OP-2 based on the sum assured in total if no claims were made earlier or on the remaining balance of the sum assured if claims were settled, after honouring court awards against OP-2, but not directly to the Complainant. As regards her treatment at Mediciti Hospital, OP-3 noted that she was discharged after conservative treatment for three days, with a stable condition and no complications, as per the Complaint's own averments. OP-3 argued that since there was no indication that the corrective surgery at Mediciti Hospital was due to negligence by OP-1, and the advice given thereat aligned with that of OP-2 regarding diet, any further issues, such as abdominal pain, were attributed to her deviation from medical advice. OP-3 highlighted the absence of independent expert opinions supporting her allegations of negligence by OP-2 doctors. Without such evidence, it cannot be concluded that there was negligence her treatment. As she underwent a subsequent surgery for colostomy closure, which was a continuation of the earlier treatment plan, there was no negligence by OPs. OP-3 asserted that the professional indemnity policy did not apply, and therefore, there was no obligation for indemnification. OP-3 also noted discrepancies in the Complainant's claimed amount compared to the total treatment charges, deeming the claim unjustified. As a result, OP-3 prayed for dismissal of the complaint with costs.
12. The learned State Commission vide order dated 21.03.2017, partly allowed the Complaint No. 104 of 2013 with the following findings / reasons:
35. In this case, the opposite party no.1 who had stated in the affidavit that she has been working since 12 years in the opposite party no.2 hospital and has been actively doing the laparoscopic surgery in the hospital and till now she has conducted about 700 laparoscopic operations and out of which nearly 500 are laparoscopic hysterectomy. Even in the present case the complications were duly overcome and encountered by opposite parties by diagnosing the disease in time and in curing the same properly. This proves that she had committed negligence that may happen without her knowledge but this has to be compensated by the opposite parties by way of waiving medical expenses for the second and third surgery which they had undertaken in the opposite party no.2 hospital. The opposite parties no.1 and 2 stated in their version that on humanitarian grounds they waived Rs65,121/- out of total amount that was spent by the complainant Rs.6,31,542/- as stated by the complainant for three surgeries. The two surgeries that were conducted by the opposite parties is not because of the complainant's fault but for the negligence committed by the opposite parties.
36. Though the complainant alleges that she had spent Rs. 10,00,000/- she did not file all the bills. When the complainant could prove that there was negligence on the part of opposite party no.1 and made her to spend the amounts in opposite party no.2 hospitals, we are of the opinion that the complainant is entitled to the amount spent towards treatment. She was an inpatient all through from 27.06.2012 to 12.07.2012 and again 14.07.2012 to 21.07.2012, and from 27.08.2012 to 02.09.2012. Considering the nature of the treatment and negligence that could be attributed to the opposite party no.1 we are of the opinion that an amount of Rs.3,00,000/- in all could be granted towards medical expenses and compensation. Since we are awarding compensation, we do not intend to award any interest.
In the result, the complaint is allowed in part, directing the opposite parties 1 and 2, jointly and severally to pay a sum of Rs.3,00,000/ to the complainant, towards medical expenses, as well as mental agony, sufferings etc., with cost of Rs.10,000/-. Time for payment four weeks from the date of order, failing which the amount so awarded, shall carry interest @12% p.a., from the date of failure, till realization. Since the relationship between the opposite parties no.1 and 2 is that of employer and an employee. Hence, the opposite party no.2 hospital is vicariously liable to pay the said amount. The opposite party no.3 being the insurer of the professional indemnity policy is liable to pay the said amount and costs awarded against the opposite party no.2, the insured."
13. Aggrieved by the Order of the State Commission, the Complainant as well as OP-1 and 2 filed the present cross Appeals before this Commission with following prayers:
FA/918/2017 - filed by the Complainant- Parveen Bano-
"Therefore, it is prayed that the Hon'ble Commission may be pleased to set aside the order of the Telangana State forum, Hyderabad made in C.C.No.104/2013 dt:21.03.2017 and consequently allow the appeal as well as complaint prayed for with full compensation of Rs.35,00,000/- with costs and interest at the rate of 12% since the time of filing the complaint as appealed and pass such order or further orders in the interest of the justice else I will put to great loss and hardship."
FA/1773/2017 - filed by the Opposite Party No. 1 and 2- Dr. V. Padmavathi & Yashoda Hospital.
allow the appeal and set aside the impugned order dated 21.03.2017 of the Hon'ble Telangana State Consumer Disputes Redressal Commission at Hyderabad passed in C.C. No. 104 of 2013; and pass any other /further order(s) as the Hon'ble Commission deems fit in the facts and circumstances of the present case.
14. The main issues to be determined in the case are as follows: -
Whether the complications, which arose with the Complainant following her first surgery on 27.06.2012, are ordinarily associated with the procedure "TLH"?
If so, whether the risks associated with such surgery were explained to the patient or her guardian(s), in compliance the regulations or guidelines of Medical Council of India?
The applicability of endometriosis, as noted by the Opposite Party/Hospital, which differs from the Diagnostic Report dated 10.02.2013 by Vijaya Diagnostic Centre and its bearing on the contentions of both the sides?
Justification along with reference to the available material documents regarding the Complainant's final claim under different heads towards compensation.
15. As regards the alleged complications encountered during the surgery, the Complainant had brought out the following: -
Date reported Complications 27.06.2012 Bladder and Bowel Injury (findings in operation notes (pg.460) (informed to husband of appellant post-surgery around 11.00 PM. (post-operative consent) 28.06.2012 Blood Stools and Vomiting 01.07.2012 Pneumoperitoneum Post Surgical Squalae and Extensive Surgical Emphysema | Injuries Caused to Rectum and bladder 02.07.2012 Sepsis Tachycardia and Respiratory Failure 21.07.2012 Esophagitis & Erosive Pan Gastritis
16. The Complainant further contended that the complications experienced were not typically associated with the TLH procedure. The Complainant presented a compilation of data sourced from various studies, as analyzed in a 2018 comparative study titled "Total Laparoscopic Hysterectomy for benign disease: outcomes and literature analysis," published by Springer Open. This study involved a retrospective analysis of 361 consecutive cases, with data collected prospectively from January 2012 to June 2016, involving women who underwent TLH. Clinical, demographic, surgical, and intra and perioperative data were recorded, and complications were graded on the Clavien-Dindo morbidity scale. The findings were then compared with existing medical literature. Relevant excerpt from this analysis is:
Values are given as number (percentage) unless stated otherwise Data considered for 427 patients with a successful TLH (no laparotomy conversion) Operations for pelvic abscess, pelvic peritonitis, or hematoma are included Reoperation for bowel adhesions and port side hernia are included *The difference with the data of the present study is statistically significant (p < 0.05)
17. Therefore, seven distinct studies assessing the risks associated with TLH confirmed that the complications experienced by the Complainant (Bladder Injury, Bowel Injury) are not typical in nature. Therefore, it can be inferred that these complications are a result of negligence on the part of the OP-1 and 2 and, therefore, they are liable for consequences.
18. On the other hand, OP-1 and 2 asserted that at the time of admission, the Complainant was diagnosed with 'Uterine Fibroids'. The surgery performed was Total Laparoscopic Hysterectomy (TLH) along with Bilateral Salpingo-oophorectomy (removal of ovaries and fallopian tubes) and Adhesiolysis (surgery to remove adhesions from inside the uterus). The pre-operative findings indicated that the Uterus was anteverted, approximately 6-8 weeks size, with irregular contour and studded with fibroids measuring about 4x4 cm at the fundal area and 2x2 cm in the lower uterine region. Extensive endometriosis involving the bladder, rectum, bowel loops, and ovaries was observed, with bilateral tubes and ovaries adherent to the bilateral uterosacral ligaments posteriorly and trapped into the pouch of Douglas. Additionally, the peritoneal fold along with bladder fibers was densely adherent to the lower uterus over the cervix. The integrity of the bladder margins was checked by filling it with normal saline. The uterus with cervix, bilateral tubes, and ovaries were removed and sent for histopathological examination. The possibility of expected bowel and bladder injury, to be revealed after 1 week and possibly requiring relaparotomy, was explained to the Husband prior to surgery. According to the OP-1 & 2, the following are the Complications that arose after the surgery dated 27.06.2012:-
27.06.2012 at 7.00 PM-Stable, no active bleeding, clean urine output.
28.08.2012- No complaint, conscious, coherent. However, complaint of per Vaginal bleeding.
29.06.2012 - No complaint, no bleeding.
30.06.2012- Complaint of pain in the abdomen - interference of Dr. Ramakrishna and Dr. Padmavathi-Patient not willing to comply with advise.
01.07.2012- gaseous distention-advice of C.T. abdomen and Rectal contrast - patient not willing to undergo test.
02.07.2012 -diagnosis of rectal perforation, post laparotomy sepsis and respiratory failure.
19. OP-1 and 2 further contended this aspect and brought on record medical literature references such as "Rectal Perforation During Pelvic Surgery" by Bernardo Rocco et al, "Large Bowel Injury During TLH" by Malvika Sabharwal, and the 6th Edition of "Te Linde Operative Gynecology" by Richard F. Mattingly and Dr. John Thompson, among others, to support their contention.
20. As regards obtaining informed consent, the Complainant contended that the risks involved in the treatment and surgery were never adequately explained to them, and the consent obtained for the surgery was neither proper nor valid. Moreover, there is no evidence on record to suggest that the Complainant or her husband were informed about the potential complications associated with the procedure for which consent was sought. She placed reliance on Rule 7.16 of the Professional Conduct and Ethics Regulations, 2002, issued by the Indian Medical Council, which pertains to obtaining express consent. Further, she asserted that the minimum standard guidelines for obtaining consent, as applicable in India at the time of the incident, are outlined in "The Clinical Establishment (Registration and Regulation) Act, 2010." Entry 5 under Appendix 9 of the Act mandates that potential complications must be explained to the patient, among other requirements, to meet the minimum standards of consent prescribed under the Act. Therefore, she contended that the signatures of her husband were obtained post-surgery at 11:00 PM on the operation notes, which documented the possibility of bladder and bowel injury. This suggests that such information was provided as an afterthought by the OPs after the damage was already done during the operation on her.
21. On the other hand, OP-1 and 2, in their response admitted the existence of Rule 7.16 of the Professional Conduct and Ethics Regulations, 2002, concerning consent. They contended that the National Medical Commission (Professional Conduct) Regulations, 2023, delineate various types of consent and their applicability to different medical procedures. OP-1 and 2 contended that the consent obtained by them was in accordance with the rules prevailing in 2012 and the most recent regulations. In the present case, OP-1 and 2 contended that they obtained both General Consent and Specific Consent for the surgery, which were duly signed by the patient's husband and endorsed by OP-1. Additionally, they obtained consent for High-Risk surgery from the husband of the patient. The risks and complications associated with TLH were explained to the patient's husband, and the patient and her husband signed the consent forms on 27.06.2012. This information was also detailed in the patient and family education chart, where the complications and risks of surgery were explained to the patient and her husband, and the husband signed accordingly. Further, post-surgery, the doctor reiterated the complications in the operation notes, which were signed by the husband in acknowledgment.
22. As regards the issue concerning applicability of endometriosis as noted by OP-1 and 2, which differs from Vijaya Diagnostic Centre report dated 10.02.2013 the Complainant relied on an order of the learned State Commission, the excerpt of which are as follows:
"...Therefore, the claim of the opposite parties' no.1 that she had discussed in detail about endometriosis and the treatment on the basis of her personal examination and ultrasound report appears to be doubtful."
23. On the other hand, the OP-1 and 2 contended that unless the disease is visible during the vaginal examination or elsewhere, laparoscopy remains the standard technique for visually inspecting the pelvis and establishing a definitive diagnosis. As per the latest edition widely followed by postgraduates and practitioners of Gynaecology, "BEREK & NOVAKS Gynaecology South Asian Edition (Pg. 292)," during diagnostic laparoscopy, the pelvic and abdominal cavity should be systematically investigated for presence of endometriosis. OP-1 and 2 emphasized that endometriosis is not diagnosed solely by imaging techniques but rather on the basis of clinical symptoms and naked-eye visualization of endometriosis spots and lesions during surgery, which was done in the present case by their gynaecological team. They confirmed the diagnosis of endometriosis through histopathological examination of the specimen as was conducted in this case. The surgery was carried out with suspicion of endometriosis, and the subsequent procedure revealed extensive endometriosis, according to the Respondents.
24. As regards justification for the Complainant's final claim under different heads towards compensation, the Complainant submitted a breakdown of medical expenses incurred since the first TLH surgery on 27.06.2012 until 17.11.2019, amounting to a cumulative total of Rs.11,30,746. Additionally, the Complainant stated that she was previously employed as a computer operator at Bimco Isolators Pvt. Ltd. but had to leave her job due to multiple surgeries and subsequent complications and produced a company letter. She thus claimed a loss of Rs.18,00,000 (pay for 10 years @ Rs. 15,000 PM) from 30.09.2012 to 31.10.2023. She thus justified her claim of Rs.25 Lakhs towards compensation based on these factors.
25. In FA/918/2017, the learned Counsel for the Complainant/ Appellant reiterated the case facts and argued for enhancement of compensation granted vide Impugned Order of the learned State Commission which partially allowed the complaint, directing OP-1 & 2 to pay Rs.3,00,000/- as compensation along with 12% interest. She asserted the entitlement for reimbursement of Rs.6,31,542/- towards hospital bills related to three surgeries and expenses totalling Rs.10,00,000/- for other medical bills, medicines, travel expenses, private nursing care during one year of bedridden condition and other hospital expenses incurred by the Complainant. She sought setting aside of the Impugned Order and grant Rs.25,00,000/- as compensation. She also sought an additional Rs.10,00,000/- for the costs associated with the three surgeries, along with interest at 12% from the date of filing the complaint.
26. On the contrary, the learned counsel for the Respondents/OP-1 & 2 argued that the principle of "Res Ipsa Loquitur" is inapplicable in the present case because the Complainant failed to provide any evidence demonstrating medical negligence on the part of OP-1 & 2. They emphasized that the treatment administered to the Complainant at Mediciti Hospital and the medical advice provided by OP-1&2 were consistent, which is clearly documented in the discharge summary issued by Mediciti Hospital, which attributes the exacerbation of the Complainant's abdominal pain to consumption of solid food, indicating non-compliance with the prescribed liquid diet advised by OP-1 & 2. Further, after conducting an ultrasound examination, multiple fibroids were detected, leading OP-1 & 2 to recommend Total Hysterectomy Surgery due to clinical suspicion of endometriosis. This decision was based on the diagnostic findings and professional judgment of OP-1 & 2, aiming to address her medical condition appropriately. She further argued that the Hon'ble State Commission failed to properly consider that laparoscopic surgeries, by their nature, entail certain known risks and complications. Citing authoritative sources such as the "Telende' textbook, 10th edition, page 333," the counsel highlighted that general statistics indicate a 3.6% risk of bowel injury and a 1 in 300 risk of urinary tract injury during such procedures. These figures underscored the inherent risks involved in laparoscopic surgeries, including those performed on the Complainant. The learned counsel emphasized that the treatment provided to the patient at Mediciti Hospital was conservative and lasted only three days, after which she was discharged in stable condition with no reported complications. This is clearly documented in the discharge summary from Mediciti Hospital. Furthermore, the counsel pointed out that the Complainant did not submit any independent expert opinion to substantiate her allegations of medical negligence and asserted that the absence of such expert testimony undermines the claim that there was any negligence on the part of OP-1 & 2 in the treatment provided. She also asserted that an enquiry and report by the A.P. Medical Council, specifically File No. MCI-211 (2)(538)/2012 - Ethics, issued on 20.02.2023, is still pending. This pending inquiry suggests ongoing scrutiny of the matter by the medical authorities, indicating that the issue is still under official review and assessment.
27. The learned counsel for OPs further argued that during the course of surgery - intra-operatively - it was observed that the patient had extensive endometriosis. This condition involved the bilateral tubes and ovaries, which were adherent to the uterosacral ligament. Additionally, endometriosis was found to affect the rectum, pouch of Douglas and bowel loops. Given the extent of endometriosis observed, the doctors decided that a bilateral salpingo-oophorectomy was necessary. During the procedure, the integrity of the bowel was meticulously checked under the supervision of another General Surgeon. Similarly, the bladder integrity was assessed by filling it with normal saline, and no apparent injuries to the bowel or bladder were detected. The counsel emphasized that even in cases of extensive endometriosis, the likelihood of inadvertent organ damage is estimated to be approximately 1 in 100 cases. Following these procedures, further precautionary measures were taken. Due to dense endometriosis spots observed on the bladder, a cystoscopy and bilateral ureteric catheterization were performed by an Urologist. This step was aimed to rule out any perforation or ureteric injury, and it was carried out with extra caution to avoid the need for additional surgeries in the future due to severe endometriosis. Fortunately, no obvious injuries to the bladder or ureter were identified, and the rest of the abdominal organs and bowel were confirmed to be normal during the surgical assessment. The learned counsel further contended that OP-1 is a highly qualified and very experienced doctor, specializing in laparoscopic surgeries, with over 12 years of service at OP-2 hospital. Throughout her career, OP-1 has performed about 700 laparoscopic operations, including nearly 500 laparoscopic hysterectomies and other procedures such as diagnostic laparoscopy and ovarian cystectomy. Notably, there have been no complications reported even in cases involving high-risk patients. She, therefore, argued that the First Appeal filed by Appellant No. 918 of 2017 should be dismissed with costs. Conversely, the First Appeal filed by the Appellants in FA No. 1773 of 2017 be allowed in the interest of justice. Additionally, the counsel for the Respondents/OPs contended that raising a new factual ground at the stage of First Appeal is impermissible. In this case, the contention that the ovaries were removed without consent by OP was not raised before the learned State Commission. It was not raised in the memo of appeal filed before this Commission was well. To substantiate this argument, the Respondents/OPs cited the following judicial precedents:
a. Samir Chandra Das vs Bibhas Chandra Das (2010)6SCC 432.
b. State of Maharashtra vs. Hindustan Construction Company Ltd. (2010) 4 SCC 518.
c. Ram Sarup Gupta (dead) by LRs., vs. Bishun Narain Inter College AIR 1987 SC 1242.
28. We have examined the pleadings and associated documents placed on record and rendered thoughtful consideration to the arguments advanced by learned counsels for both the parties.
29. The main issues to be determined are:
A. Whether the complications which arose with the Complainant post her first surgery on 27.06.2012 are ordinarily associated with the TLH procedure?
B. If that is so, whether the risks associated with such surgery were explained to the patient/guardian in compliance of the guidelines of the Medical Council of India and consent was obtained?
C. Whether the existence of endometriosis suffered by the patient could have been diagnosed with checks/tests prior to the surgery?
D. Is there any difference in the diagnosis of endometriosis by the OPs and the report of the Vijaya Diagnostic Centre? If so, what is the impact on the allegations of medical negligence? What is the scope for award of compensation in the case?
30. As regards the issue whether the complications that arose with the Complainant post her first surgery on 27.06.2012 are ordinarily associated with the TLH procedure, the OP-1 and 2 asserted that at the time of admission, the Complainant was diagnosed with 'Uterine Fibroids'. The TLH surgery was performed along with Bilateral Salpingo-oophorectomy (removal of ovaries and fallopian tubes) and Adhesiolysis (surgery to remove adhesions from inside the uterus). The pre-operative findings indicated that the Uterus was anteverted, approximately 6-8 weeks size, with irregular contour and studded with fibroids measuring about 4x4 cm at the fundal area and 2x2 cm in the lower uterine region. Extensive endometriosis involving the bladder, rectum, bowel loops, and ovaries was observed, with bilateral tubes and ovaries adherent to the bilateral uterosacral ligaments posteriorly and trapped into the pouch of Douglas. Additionally, the peritoneal fold along with bladder fibers was densely adherent to the lower uterus over the cervix. The integrity of the bladder margins was checked by filling it with normal saline. The uterus with cervix, bilateral tubes, and ovaries were removed and sent for histopathological examination. The possibility of expected bowel and bladder injury, to be revealed after 1 week and possibly requiring laparotomy, was explained to the Husband prior to surgery. As per OP-1 & 2, the following complications arose after the first surgery on 27.06.2012:-
28.08.2012- Complaint of per Vaginal bleeding.
30.06.2012- Complaint of pain in the abdomen.
01.07.2012- gaseous distention-advice of C.T. abdomen and Rectal contrast.
02.07.2012 -diagnosis of rectal perforation, post laparotomy sepsis and respiratory failure.
31. OP-1 and 2 brought on record medical literature references such as "Rectal Perforation During Pelvic Surgery" by Bernardo Rocco et al, "Large Bowel Injury During TLH" by Malvika Sabharwal, and the 6th Edition of "Te Linde Operative Gynecology" by Richard F. Mattingly and Dr. John Thompson, among others, to support their contention.
32. As regards the issue whether the said risks associated with the surgery were explained to the patient and whether OPs obtained valid Consent from the patient or her relatives. Upon careful examination of the material on record, it is evident that the OPs obtained certain consents from the patient through standard specimen forms, namely 'General Consent', 'Consent for Surgery', and 'High Risk Consent' at different stages.
General Consent: The patient provided General Consent upon admission on 27.06.2012 on record in Volume IV, Page No. 456.
Consent for Surgery: Prior to the surgery, on the pre-operative stage also on 27.06.2012, the patient signed a 'Consent for Surgery' form, detailed in Volume V, Page No. 779.
High Risk Consent: Additionally, specific consent for high-risk procedures associated with Total Laparoscopic Hysterectomy (TLH) was obtained. This is supported by the Per-operative (OT Notes) findings documented in Volume V, Page No. 781, which indicate that potential complications, including bowel and bladder injuries, were explained to the patient's husband.
33. These consent forms were designed to ensure that the patient and her family members are informed about the risks associated with the surgery and are aware of the potential complications that could arise. The documentation also suggests that adequate steps were taken by the OPs to obtain valid consent from the patient or her relatives at each critical stage of the treatment process.
34. A valid consent is a legal requirement of medical practitioners, not mere procedural formality. It is most relevant in medical negligence cases, specifically, when such case comes under judicial scrutiny. Except in medical emergency case, the informed consent must be taken before any investigation, procedure or treatment. In medical emergencies, life-saving treatment can be given even in the absence of consent. Chapter 7 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Clause 7.16 of the Regulations reads as under:
"7.16 Before performing any operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed."
35. In the area of medical negligence, the contentious aspects of medical care can be broadly categorized into three categories:
A. Diagnosis: Means medical condition/status of the patient;
B. Advice: treatment options reasonable alternatives and risk attending on various options; and C. Treatment.
36. The material difference between these aspects of medical care lies in the degree of passivity on the part of the patient. The diagnosis and treatment are in the domain of doctor, and the patient is a passive participant. When advice is being given to the patient, the patient assumes an active role. Then doctor's function is to empower and enable the patient to make a decision by giving him relevant, sufficient and material information. The patient must make choices and decisions. The patient must be informed about the options for treatment, its consequences, risks and benefits. Why doctor thinks particular treatment necessary and appropriate for the patient. The prognosis and what may happen if treatment is delayed or not given. Failing to furnish correct sufficient information when obtaining consent may be a breach of duty of care. It amounts to negligence, failure to inform the patient. The patient must be given a reasonable amount of time to consider the information to make a decision. The allowing of cooling off period is for the purpose to give time to think over the decision or take advice so that patient does not feel pressurised or rushed to sign. On the day of surgery, the patient may be under strain, mental stress or under influence of the pre-procedure drugs which may hamper his/her decision-making ability. The doctor performing any procedure must obtain patient's consent and none else can consent on behalf of a competent adult. The consent should be properly documented and preferably witnessed as such consent is legally more acceptable. The video recording of the informed consent process may also be done with a prior consent of the patient for the same.
37. Now, we would like to discuss with regard to the "Bolam Test". It was articulated in 1957. At that point of time, emphasis was not on the principle of autonomy rather on the principle of beneficence. The doctor was considered to be the best person and the patient was kept in dark with regard to the risks and alternative treatment relating to the illness. Now there is a seismic shift in medical ethics and societal attitude towards the practice of medicine. Furthermore, the Medical Council has framed statutory regulations regarding the professional conduct, etiquette and ethics. This warrants legal tests to adjudicate the advice aspect of doctor patient relationship. The MCI Regulations as amended up to date clearly stipulate the need to respect the patient autonomy and doctor's obligation to adequately inform the patient for self-determination. Nature of the patient doctor relationship has to be examined in the light of education and access to the knowledge of ordinary citizen. In the light of these facts and statutory provisions, the "Bolam Test" can no longer be applied to a doctor's advice to his patient, unless it complies with the statutory provisions. The information given to the patient has to be examined from patient's perspective. The information disclosed is not limited to the risk-related information. It should include doctor's diagnosis of the patient's condition, the prognosis of that condition with and without medical treatment, the nature of proposed medical treatment and the risks associated with it, the alternative to the proposed medical treatment, advantages and risks of the said treatment and the proposed treatment. The doctor must ensure that information given is "in terms and at a pace that allows the patient to assimilate it, thereby enabling the patient to make informed decision". At the same time, three instances, where withholding of information is justified, are as under:
"a) Waiver situation: is when the patient expressly indicate that he does not want to receive further information about the proposed treatment or the alternative treatment.
b) Medical emergency: when life-saving treatment is required and the patient temporarily lacks decision-making capacity. The "Bolam test" would continue to apply.
c) Therapeutic privileges: when the patient has mental capacity, his decision-making capabilities are impaired to an appreciable degree such that doctor reasonably believes that the very act of giving particular information would cause the patient serious physical or mental harm. For example, the patient with anxiety disorder."
38. Now, we will examine whether before undergoing surgery, the patient or her husband/relatives were informed about the possible complications and risks and their informed consent was taken. It is true that every operation, as small as it may be, carries a wide range of risks from the most insignificant to the most serious, may lead to fatal complications. Discussing all the complications with the patient and attending relatives is a necessity, so that he/she/they may make up his/her/their mind before undergoing the surgery. Before commencing the treatment or procedure, now a days, an 'Informed Consent' is required to satisfy the following conditions:
"The consenting party i.e. patient or his/her family members must be aware of the nature and extent of complications and risks of the surgery. The consenting party must have understood the nature and extent of the complications and risks and the consenting party or his/her family members must have consented to the harm and assumed risk. Comprehensive explanation of the possible complications and risks and the extent of entire procedure and transaction, inclusive of all its consequences, must be explained to the patient or his/her family members."
39. In Samira Kohli Vs Dr. Prabha Manchanda & Another 1(2008) CPJ 56 (SC), Hon'ble Supreme Court has extensively dealt with the concept of consent to be taken from the patient or his family. In the said case, it has been held that patient has an inviolable right in regard to his body and he has a right to decide whether or not he should undergo the particular treatment or surgery .It was further held by the Hon'ble Supreme Court that unless the procedure is necessary in order to save the patient's life or preserve his health and it would be unreasonable to delay the further procedure until the patient regains consciousness and takes a decision, a doctor cannot perform such procedure without the consent of the patient. In the instant case, as discussed above the insertion of catheter by Central Venous Line procedure being an invasive procedure carrying certain risk of complication including the injury to the jugular vein or bursting of the blood cells, the team of doctor was legally required to obtain the consent of the patient." Identical view was taken by the U.K. Supreme Court in "Montgomery (Appellant) v. Lanarkshire Health Board (Respondent) (Scotland)" Hilary Term [2015] UKSC 11 on appeal from: [2013] CSIH 3; [2010] CSIH 104, wherein also the concept of informed consent has been emphasized.
40. It is settled principle of law that the 'Informed Consent' of the patient/relatives is a necessity. In the present case, the patient signed her General Consent upon admission on 27.06.2012 on record in Volume IV, Page No. 456. With respect to the surgery, she signed a Consent for Surgery prior to the surgery also on 27.06.2012 on record in Volume V, Page No. 779. This consent form explicitly states that "I solemnly affirm that risks versus benefits, potential complications arising out of operation and anaesthesia as stated in the standard textbooks and/or idiosyncratic, were explained to me. I also affirm that I was informed about the alternatives'. Since the scope of the surgery was stated to have changed during the course of operation due to the presence of endometriosis, the High-Risk consent for further procedure procedures associated with TLH was taken immediately after the surgery as part of OT Notes that the patient is "Expected bowel & bladder injury to be revealed after 1 week & may need relaparotomy. Risk has been explained to husband." This was recorded in Volume V, Page No. 781.
41. In view of the foregoing, we are of the considered view that the OPs obtained 'Informed Consent' of the patient for the TLH surgery, except for the High-Risk surgery consent which was obtained immediately after the surgery. The validity of this surgery would depend upon determination whether the presence of endometriosis as well as removal of ovaries and fallopian tubes could not have been reasonably foreseen and that the situation is such that the surgery is so urgent and, as a sequel, the consent was obtained later.
42. To determine whether presence of endometriosis could have been detected beforehand or the magnitude of its presence could have been revealed only during surgery, undisputed that the following are the main diagnostic methods to ascertain the presence of endometriosis before surgery:
A. Pelvic Exam: During physical examination unusual changes in the pelvis, including cysts on reproductive organs, painful spots, irregular growths (nodules), and scars behind the uterus. However, small areas of endometriosis may not be felt unless a cyst has formed.
B. Ultrasound: This imaging test uses sound waves to create pictures of the inside of the body. A transducer is either pressed against the stomach or inserted into the vagina (transvaginal ultrasound). While a standard ultrasound won't confirm endometriosis, it can detect cysts associated with the condition (endometriomas).
3. Magnetic Resonance Imaging (MRI): An MRI provides detailed images of organs and tissues using a magnetic field and radio waves. It helps with surgical planning by revealing the location and size of endometriosis growths.
D. Laparoscopy: The definitive diagnosis occurs through laparoscopy, a minimally invasive surgical procedure. Your surgeon makes a small incision near your navel and inserts a slender viewing instrument called a laparoscope. This allows them to directly visualize the abdomen and identify endometriosis tissue. Biopsy samples may be taken for further testing during the procedure. Early detection and accurate diagnosis are crucial for effective management of endometriosis.
43. It is undisputed that endometriosis is a condition in which uterine tissue grows outside the uterus in the abdomen or pelvic area and it can cause pain and excessive bleeding during period of a woman. It can also make it harder to conceive. If the doctor suspects endometriosis, the doctor may commence hormone therapy as a first-line treatment. But, if a patient is trying to get pregnant, or cannot take hormones, the doctor may suggest surgery. Doctors typically use minimally invasive techniques to treat endometriosis surgically. The incisions are very small, which makes recovery easier. Some people need more extensive endometriosis surgery, such as hysterectomy, so it's important to be informed about the risks and benefits of different procedures. The most common way adopted to confirm a diagnosis of endometriosis is with a procedure called a laparoscopy, sometimes followed by a tissue analysis. Some surgeons do imaging tests before surgery, such as an ultrasound or MRI, to get a better idea of the location of endometrial implants. Most gynecologists can perform laparoscopies and remove limited endometriosis. But special skill is required when the implants are widespread or in places that are hard to get to. The surgical experience and expertise of the surgeon and the medical condition of the patient are material. When there is a possibility of endometriosis in or near the bowel, the patient needs to do bowel prep, which was undertaken. Under general anesthesia, the procedure will be performed and the doctor will follow from 2 to 6 weeks after the surgery, as endometriosis can recur after surgery. The patient may have to undergo hormone therapy to reduce the chance of the implants coming back.
44. Endometriosis and Hysterectomy. Occasionally, endometriosis may cause severe symptoms and when other treatments are not working, the surgeon may suggest hysterectomy to remove the uterus. There is debate about this procedure because, as the endometrial tissue lies outside the uterus, removing the uterus may not address the problem. The decision to have a hysterectomy or remove other reproductive organs is a serious one, because it means a patient will not be able to have children afterwards. If she is premenopausal and the operation includes ovary removal also, she will enter menopause. There are different surgical approaches for hysterectomy. In most cases, hormone therapy or laparoscopy will reduce pain and bleeding. While relief from the symptoms of endometriosis is feasible without surgery, but where it is necessary, surgery can be effective and give years of pain relief.
45. In the case in question the main issue is the diagnosis of endometriosis by the OPs prior to the surgery. Essentially, endometriosis is an inflammatory disease that resembles endometrial tissue when examined under the microscope. Endometriosis tissue contains endometrial glands and stroma but that is the only similarities it shares with normal endometrium. The endometrium is the inner layer of the uterus that is shed off when a woman gets her period. Endometriosis may grow anywhere in the body but is most commonly seen around the ovaries, peritoneum, ligaments of the uterus and gastrointestinal system. It is a multi-systemic disease and is not just limited to the genito-urinary system. Estrogen hormones which are secreted when a woman starts menstruating cause the endometriosis to grow and invade body tissues resulting in painful adhesions, scarification and disruption of other organ systems. Tissue growing into the rectum and bowel produces constipation or diarrhea, if it grows into the ovary or tubes it causes infertility, if it grows within the vagina and the back of the uterus it causes painful sexual intercourse and also produces inflammatory processes causing generalized abdominal pain and bloating. The disease grows and pulls everything towards it, causing entrapment of nerves and produces new blood vessels. This causes sequelae depending on what nerves and vessels are impacted ranging anywhere from sexual function to altered urinary function and/or bowel functions.
46. There are many ways to classify endometriosis based on the guidelines by different endometriosis societies. While there is always scope for debate about surgical stages, in general, the following are the stages of endometriosis:
A. Stage-1. The very first and most minimal stage and a patient may have small adhesions and small amounts of endometrial tissue on an ovary. It may also include inflammation in or around the pelvic area.
B. Stage-2. More adhesions on or around the ovaries. These adhesions are defined to be "too insignificant" at this stage and are usually too small to be picked up on ultrasound, unless the doctor pays attention to probe tenderness in the region while examining the ovary.
C. Stage-3. This is the moderate stage at which adhesions will be blatantly obvious and usually there may be cysts on the ovaries. There may be growths in other areas of the pelvis blurring into the territory of stage 4 endometriosis.
D. Stage-4. The final stage of endometriosis. Associated with large number of cysts and severe adhesions. Most of the cysts will appear on the ovaries while the adhesions will appear over the pelvic lining and may affect the fallopian tubes and bowels. This can make bowel movements terribly uncomfortable and period pain the absolute worst.
47. The most common symptom of endometriosis is pelvic pain which may manifest in many ways including painful periods (during the first couple of days). Patients usually describe this like a sharp stabbing pain sometimes radiating to the lower back and down the legs, or around the groin and lower abdomen; mid cycle pain (during ovulation; painful sex; constipation and bloating (the dreaded endo belly); pain while urinating (bladder endometriosis); and shoulder pain or difficulty breathing (in rare cases of diaphragmatic endometriosis)
48. There are multiple inferences as to what causes endometriosis. Unfortunately none of these theories have been extensively proven. The most popular theory of retrograde menstruation propagated by Sampson is still being touted as the most likely cause of endometriosis till today, even though there is significant evidence to the contrary. Sampson's theory of retrograde menstruation states that during menstruation, pieces of endometrium arrive in the abdominal cavity through the Fallopian tubes, adhere to the peritoneal lining and develop into endometriotic lesions. For long time people wrongly believed that endometriosis consists of the endometrial lining of the uterus. It has low and varying levels of hormone receptors compared to native endometrial tissue and behaves differently than native endometrium. Metaplasia means to change from one normal type of tissue to another normal type of tissue. It has been proposed by some that endometrial tissue has the ability in some cases to replace other types of tissues outside the uterus. The most plausible theory with what knowledge we have today is Mulleriosis, the current best-fit model of the origin of endometriosis, refers to a developmental defect in the differentiation or migration of any cellular component of the müllerian duct system during embryonic development.
49. The Gold Standard of diagnosis is excision of endometriosis tissue by laparoscopy. But laparoscopy requires anaesthesia and is an expensive procedure. Therefore, a diagnosis needs to be established before laparoscopy is implemented as a one-stop see and treat measure. Therefore, it must be done by people who specialise in endometriosis excision. Endometriosis is highly suspected if the patient complains of dysmenorrhoea (Painful periods), dyspareunia (Painful sexual intercourse), abnormal bleeding and subfertility. Symptoms such as nosebleeds, haematochezia (blood in stools) and blood in urine among others which would lead one to a suspicion of extra-genital endometriosis. Clinical identification of endometriosis is generally feasible in the form of:
A. Clinical Examination: A vaginal and rectal exam is ideally performed to feel for nodularity and mobility of the uterus. If any nodularity is noted then one will suspect deep endometriosis. Adnexal masses on palpation may be suggestive of endometriosis.
B. Ultrasonography: Transvaginal ultrasound is the best non invasive method to diagnose endometriosis. It may reveal cysts, rectovaginal nodules and adherent ovaries. It may not reveal much peritoneal disease. In younger girls who are not sexually active a trans-rectal approach is much better for diagnosing endometriosis than a transabdominal one.
C. MRI: Useful in detecting rectovaginal disease but not much better than a well performed ultrasound.
D. Laparoscopy: As mentioned before laparoscopy is the gold standard for diagnosis of endometriosis. The advanced optics and modern imaging modalities with HD, 4K, 3D and Near-Infra Red Imaging systems improve visual acuity in identifying lesions as never before. Subtle endometriosis lesions may be missed if he/she hasn't seen them before.
50. The Case of the Complainant is that she approached the OP-1 on 22.06.2012 reporting symptoms of dysmenorrhea and menorrhagia persisting for two years, accompanied by intermittent abdominal pain. She had a medical history of controlled diabetic mellitus, hypothyroidism, and hypertension. OP-1 recommended a Total Laparoscopic Hysterectomy (TLH) after diagnosing uterine fibroids based on an Abdominal Ultrasonography report dated 22.06.2012, supplemented by further tests conducted at OP-2 Hospital. On 27.06.2012, she underwent TLH surgery at OP-2 Hospital. Allegedly, OP-1 failed to disclose to the Complainant and her husband the suspicion of Endometriosis, as indicated in the discharge summary and the first and second Operation Notes. The absence of Endometriosis in OP-2's medical records suggests deception by OP-1, potentially to obfuscate complications such as bowel and bladder injuries occurring during TLH surgery. This deceit is asserted to have misled the court, rendering OP-1 and OP-2's statements erroneous.
51. Per contra, OP-1 & 2 asserted that upon admission on 27.06.2012, the Complainant was diagnosed with uterine fibroids, alongside a medical history of diabetic mellitus and hypertension under treatment for the past three years. She was also known to have hypothyroidism. Multiple fibroids were identified, prompting a decision for total hysterectomy. OPs communicated to the patient and her husband about the potential risks and complications associated with laparoscopic hysterectomy, including anticipated bowel and bladder injuries that might manifest post-surgery, potentially requiring re-laparotomy. They also informed about the risk of anesthetic complications given the underlying medical conditions such as type II diabetes mellitus, bronchial asthma, and hypothyroidism. Additionally, OP-1 & 2 cited strong clinical suspicions of endometriosis and the likelihood of encountering surgical adhesions due to the patient's history of previous caesarean section with a uterus affected by multiple fibroids.
52. Upon careful review of records, the ultrasound report dated 22.06.2012 does not indicate a provisional diagnosis of endometriosis. Further, there is no mention of endometriosis affecting other organs such as the urinary bladder, ovaries, or other parts of the abdomen in the ultrasound findings. The report did note an endometrial thickness of 6mm beneath the uterus. While ultrasound can reveal conditions like fibroids, cysts, or other abnormalities that may suggest endometriosis, it does not in itself provide a definitive diagnosis of endometriosis in the present case. As discussed above regarding diagnostic methods to ascertain endometriosis before surgery, the gold standard for diagnosis is the excision of endometriosis tissue via laparoscopy. In this procedure, a surgeon makes a small incision near the navel and inserts a slender viewing instrument called a laparoscope. This allows doctors to directly visualize the abdomen and identify endometriosis tissue. Biopsy samples may also be taken for further testing during the procedure. Early detection and accurate diagnosis are crucial for effective management of endometriosis. Moreover, OP-1 & 2 stated in their affidavit filed before the Ld. State Commission that endometriosis is not diagnosed by imaging techniques but rather on the basis of clinical symptoms, naked-eye visualization of endometriosis spots, and lesions during surgery. Confirmation of the diagnosis of endometriosis is done by histopathological examination of the specimen, as was done in this case. Therefore, OP-1 should have discussed in detail about endometriosis, its diagnostic methods, and the treatment procedure with the complainant and her family. Thus the learned State Commission found that the claim of OP-1 regarding a detailed discussion about endometriosis and treatment based on personal examination and ultrasound reports appears to be doubtful. However, OP-2 is an experienced surgeon. She has emphatically stated that the presence of endometriosis was noticed during the surgical procedure. With due regard to the interest of the health of the patient, OPs considered it appropriate to proceed with addressing the same. Further the OPs had to also decide on a Bilateral Salpingo-oophorectomy (removal of ovaries and fallopian tubes) due to the extensive endometriosis. In the process certain injuries occasioned to the patient which resulted in further surgical procedures and admission to different hospitals, pain, suffering and expenses to the Complainant.
53. With due consideration of the entire facts and circumstances of the case, while proceeding with TLH and, on diagnosing endometriosis, addressing the same as well without consent was understandable to certain extent, being inherently in the interest of the patient. At the same time, proceeding further with Bilateral Salpingo-oophorectomy (removal of ovaries and fallopian tubes) is clearly without consent is culpable as such action, notwithstanding the presence of endometriosis entailed profound and irreversible adverse impact on the patient. While the OPs asserted the procedure as the action done in good faith, the OPs ought to have obtained her and/or her husband's consent. Therefore, deficiency in service is manifest in this regard.
54. According to OP-1 & 2, intra-operatively, there was extensive endometriosis involving the bilateral tubes and ovaries, which were adherent to the uterosacral ligament. Endometriosis was also found involving the rectum, pouch of Douglas, and bowel loops. Consequently, the doctor had to decide on a Bilateral Salpingo-oophorectomy (removal of ovaries and fallopian tubes) due to the extensive endometriosis. The surgery was performed with extra caution to prevent further laparotomies because of severe endometriosis. However, no obvious injury to the bladder and ureter was found, and the rest of the abdominal organs and bowel appeared to be normal. The OPs informed the patient and her husband about the potential risks and complications during the laparoscopic hysterectomy, such as possible bowel and bladder injuries that might be revealed after a week and could require re-laparotomy, as well as the possibility of anesthetic complications. During the surgery, it appears that surgical injuries were caused to the bowel and bladder. Realizing the problem, OP-2 decided to perform an exploratory laparotomy, which included drainage of pus from the peritoneal cavity, repairing the rectal perforation, loop diversion colostomy, and cystoscopy with bilateral ureteric catheterization on 02.07.2012. However, the postoperative period was not uneventful. The drained peritoneal fluid was sent for culture and sensitivity testing. Extensive endometriosis spots were found on the bowel loops, including the rectum and bladder wall. A small 2x2 mm perforation was present on the anterior wall of the recto-sigmoid junction where dense endometriosis spots were observed. This perforation was closed in two layers with mersilk and a diversion loop colostomy was performed. Dissatisfied with the treatments provided by OP-1 & 2, the complainant was admitted to Mediciti Hospital on 21.07.2013, where she was diagnosed with sub-acute intestinal obstruction caused by complications from the first and second surgeries. The doctors at Mediciti Hospital treated her conservatively with gastrograffin for three days, and she was discharged on 24.07.2013. Thus, it is evident that the complainant sought treatments from different hospitals for the same issue. Thus, it is evident that due to the actions performed by OP-1, the complainant experienced complications, suggesting negligence under the principle of "res ipsa loquitur." This principle shifts the burden to OP-1 to prove that her actions were not responsible for the surgical emphysema and sepsis, and that these complications occurred despite her best efforts.
55. In our view, there is no need to delve further into proving the negligence of OP-1 & 2. The principle of "Res Ipsa Loquitur," meaning "the thing speaks for itself," applies squarely to this case. It is evident that there was a definitive deficiency in the services provided by the hospital (OP-2), which was expected to maintain the highest standards of essential infrastructure and patient care. However, it failed to meet these expectations, demonstrating both deficiency and unfair trade practices.
56. There are certain duties of the doctor. Those case laid down by the Hon'ble Supreme Court. In the case of Dr. Laxman Balakrishna Joshi vs. Dr. Trimbak Bapu Godbole & Anr. AIR 1969 SC 128, it was held that the doctor owes to his patient certain duties which are:
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.
57. A breach of any of the above duties may give a cause of action for negligence and the patient may, on that basis, recover damages from his doctor. In the instant case, the OP Doctors failed on all counts stated above.
58. Negligence as defined by the court in Jacob Mathew v. State of Punjab (2005)SSC(Crl)1369 that the breach of duty which one party owes to another. The duty can be in the form of an act or omission and it is referred to as the duty of care and due to the negligence of which it causes an injury to the person. In the case of medical negligence, it is the failure of medical practitioners to exercise certain acts or omission while discharging their duties with respect to their patients could not be saved.
59. In the case of Spring Meadows Hospital & anr. Vs. Harjol Ahluwalia & Anr. (1998) 4 SCC 39, Hon'ble Supreme Court observed that:-
"9. ..... Very often in a claim for compensation arising out of medical negligence a plea is taken that it is a case of bona fide mistake which under certain circumstances may be excusable, but a mistake which would tantamount to negligence cannot be pardoned. ........
10. Gross medical mistake will always result in a finding of negligence. Use of wrong drug or wrong gas during the course of anaesthetic will frequently lead to the imposition of liability and in some situations even the principle of res ipsa loquitur can be applied. Even delegation of responsibility to another may amount to negligence in certain circumstances. A consultant could be negligent where he delegates the responsibility to his junior with the knowledge that the junior was incapable of performing of his duties properly."
60. In view of the aforesaid discussion, after having held the OPs culpable for deficiency in service in no obtaining a valid consent for the high-risk surgery, it is also clear that this case involves the principle of "Res Ipsa Loquitur." Thus, there was both negligence and deficiency in service on the part of OP-1 and OP-2 Hospital. The hospital was expected to uphold the highest standards of essential infrastructure, patient care, protocols, and management, all of which it failed to provide. Hence, the order passed by the Learned State Commission stands well-reasoned and justified.
61. The Complainant raised an objections regarding discrepancies between the ultrasound report of 22.06.2012 and the discharge summary dated 12.07.2012 provided by OP-1. The ultrasound report indicated endometrial thickness present on the uterus alone, without mentioning endometriosis on other organs such as the urinary bladder or ovaries. However, OP-1's discharge summary stated the presence of endometriosis on multiple abdominal organs, including the ovaries. In support of these allegation, the Complainant has presented a report from Vijaya Diagnostic Centre dated 10.02.2013. This report, along with the fact that she underwent surgery specifically for uterine fibroids and not for endometriosis or ovarian treatment, suggests that the removal of the ovaries by OP-1 was done. The complainant alleged that the issue of endometriosis was introduced later and it contradicts the medical evidence and records from tests conducted at OP's hospital.
62. On the other hand, OP-1 & 2 contended that hat laparoscopy is the standard method for diagnosing endometriosis unless the disease is visibly present in the vagina and elsewhere. They emphasized that during diagnostic laparoscopy, thorough examination of the pelvic and abdominal cavities is essential to identify endometriosis. This examination involves systematic inspection and palpation with a blunt probe to detect nodularity, which indicates deep endometriosis affecting various organs such as the bowel, bladder, uterus, tubes, ovaries, cul-de-sac, or broad ligament. They cite the Berek & Novaks Gynecology South Asian Edition as the authoritative source followed by postgraduates and practitioners in gynecology. OP-1 & 2 further asserted that endometriosis cannot be diagnosed solely through imaging techniques but requires evaluation based on clinical symptoms and direct visualization of endometriosis lesions during surgery. They state that the diagnosis was confirmed through histopathological examination of the specimens obtained during surgery. According to their findings during the procedure, extensive endometriosis was discovered, supporting their suspicion and subsequent surgical intervention. The difference in findings raises questions about the accuracy and thoroughness of the initial diagnosis and subsequent treatment plan by OP-1 & 2. If the Vijaya Diagnostic Centre report accurately reflects the condition found before surgery, it could undermine OP-1 & 2's claim of extensive endometriosis affecting multiple organs.
63. Regarding the objection raised by the OPs regarding the absence of an independent expert opinion filed by the Complainant to support her case, reliance is placed on the judgment of the Hon'ble Supreme Court in V. Kishan Rao Vs. Nikhil Super Specialty Hospital & Anr. (2010) 5 SCC 513. The Court held:
"The expert opinion is not mandatory while adjudicating a Complaint of medical negligence. There is no whisper in the Medical Record regarding the reasons for the infection having set in and if this is a known complication what steps have been taken during that period."
64. Similarly, this case finds resonance with the decision of the Hon'ble Supreme Court in Smt. Savita Garg Vs. Director, National Heart Institute (2004) 8 SCC 56, where it was stated:
"Once a prima facie case is observed, the onus shifts on the Hospital and the treating Doctor to explain as to how a particular condition has occurred and explain the treatment that was rendered to the Patient."
65. The principles laid down by the Hon'ble Supreme Court in the aforementioned judgments are squarely applicable to the facts of the present case.
66. Regarding the quantum of compensation, the Complainant claimed Rs.35,00,000/- under various heads. It is noteworthy that the total treatment expenses amounted to Rs.10,00,000/-. However, the Ld. State Commission, after evaluating the nature of treatment provided and the alleged negligence, awarded only Rs.3,00,000/- towards medical expenses, as well as compensation for mental agony, along with costs amounting to Rs.10,000/-. In our view, the basis of computing compensation under common law lies in the principle of 'restitutio in integrum' in Malay Kumar Ganguly vs. Sukumar Mukherjee and Ors., (2009) 9 SCC 221. which, when translated, refers to ensuring that the person seeking damages due to a wrong committed to him/her is in the position that he/she would have been had the wrong not been committed. This implies that the victim needs to be compensated for financial loss caused by the doctor's/hospital's negligence, future medical expenses, and any pain and suffering endured by the victim. By no stretch of imagination, the court should award a paltry sum for gross negligence, and vice versa exemplary compensation need not be awarded in case of slight or normal negligence.
67. As the Hon'ble Supreme Court noted in Sarla Verma vs. Delhi Transport Corporation case (2009) 6 SCC 121 that "The lack of uniformity and consistency in awarding compensation has been a matter of grave concern... If different tribunals calculate compensation differently on the same facts, the claimant, the litigant, the common man will be confused, perplexed, and bewildered. If there is significant divergence among tribunals in determining the quantum of compensation on similar facts, it will lead to dissatisfaction and distrust in the system."
68. In catena of judgments the Hon'ble Supreme Court had laid down different methods to determine 'just and adequate compensation'. It was held that there is no restriction that courts can award compensation only up to what is demanded by the complainant. We would like to rely upon few judgment of Hon'ble Supreme Court viz Sarla Verma & Ors. vs Delhi Transport Corp. & Anr. 2009 (6) SCC 121, Nizam's Institute of Medical Sciences Vs Prasanth S. Dhananka & Ors. 2009 (6) SCC 1, Dr. Balaram Prasad vs. Dr. Kunal Saha & Ors. (2014) 1 SCC 384.
69. It is true that compensation cannot be calculated in a perfect mathematical sense, cannot be precise and accurate, but has to be within certain broad guidelines, and within certain broad parameters. It was observed by the Hon'ble Supreme Court in Sarla Verma's case -
"While it may not be possible to have mathematical precision or identical awards, in assessing compensation, same or similar facts should lead to awards in the same range. When the factors/inputs are the same, and the formula/legal principles are the same, consistency and uniformity, and not divergence and freakiness, should be the result of adjudication to arrive at just compensation."
70. In the Nizam Institute case, the Hon'ble Supreme Court did not apply the multiplier method. In 1990, twenty-year old Prasant S. Dhananka, a student of engineering, was operated upon at the Nizam Institute of Medical Sciences, Hyderabad. Due to medical negligence of the hospital, Prasant was completely paralysed. The court did not apply the multiplier method and awarded a compensation of Rs. 1 Crore plus interest.
71. The Hon'ble Supreme Court, in Kunal Saha case, very clearly mentioned that there were problems with using a straight-jacket formula for determining the quantum of compensation. It noted the problem in the following words:
"... this Court is sceptical about using a strait jacket multiplier method for determining the quantum of compensation in medical negligence claims. On the contrary, this Court mentions various instances where the Court chose to deviate from the standard multiplier method to avoid over- compensation and also relied upon the quantum of multiplicand to choose the appropriate multiplier ... this Court requires to determine just, fair and reasonable compensation on the basis of the income that was being earned by the deceased at the time of her death and other related claims on account of death of the wife of the claimant..."
72. Based on the foregoing discussion, the compensation awarded by the State Commission appears inadequate. At the same time, while the consent as stated was not obtained, it is also a matter of record that OP-2 is a very experienced and renowned doctor and she performed very large number of similar surgeries. It is also well known removal of endometriosis, asserted to be fairly wide spread entailed inherent risk of collateral injuries, the effect of which could only be seen a few days later. The OPs duly recorded the same and notified to the husband of the complainant immediately after the surgery. Therefore, while there is some negligence, the same is not so manifest that it had resulted in unconnected damage. There is inherent risk of collateral injuries for the surgery undergone by the complainant, had the consent been duly obtained. When once such risk is inherent due to the medical condition of the patient, liability that can be cast upon the OPs is to that extent. Therefore, having duly considered the entire facts and circumstances of the case, in the interest of justice, in our considered view, a composite compensation of Rs.6,00,000/- along with a simple interest @ 6% per annum from the date of filing of the instant First Appeal No.918 of 2017 i.e. 05.05.2017 till the date of final payment, is fair and equitable compensation in the present circumstances.
73. In view of the foregoing, the OP-1 & 2 are jointly and severally directed to pay Rs.6,00,000/- along with a simple interest @ 6% per annum from the date of filing of the instant First Appeal No.918 of 2017 i.e. 05.05.2017 till the date of final payment to the Complainant within a period of two months from the date of this order. In the event of delay beyond two months, the amount shall accrue interest at the rate of 9% per annum for such extended period until its full realization. The insurance company shall make the payment in accordance with the Professional Indemnity insurance (Medical Establishment) Policy issued to OP-1 doctor.
74. Based on the foregoing discussions, FA No. 1773 of 2017 is dismissed. FA No. 918 of 2017 is partly allowed with directions as stated above. There shall be no orders as to costs.
75. All the pending Applications, if any, are disposed of accordingly.
76. The Registry is directed to release the Statutory deposit amount in favour of OPs, if any.
......................................J SUDIP AHLUWALIA PRESIDING MEMBER ................................................................................... AVM J. RAJENDRA, AVSM VSM (Retd.) MEMBER