Appeared at the time of arguments

For the Complainant       :  Mr. Prakhar Srivastava, Advocate            

For the Opp. Parties       : Mr. Joy Basu, Sr. Advocate

  with Mr. Kanak Bose, Advocate

  Mr. Yuvraj Singh, Advocate

  Mr. Aditya Awasthi, Advocate

Pronounced on: 23^rd March 2023

ORDER

1.       The Present Complaint has been filed under section 21(A)(i) of the Consumer Protection Act, 1986 (for short ‘the Act,1986’) by Richa Jain (hereinafter referred to as the ‘Complainant’) against  the Opposite Parties  Fortis Flt. Lt. Rajan Dhall Hospital & its 2 doctors seeking compensation amount to the tune of Rs.7.10/- Crore  for negligence and carelessness of the Opposite Parties  which led to  life threatening cancer and removal of her uterus. 

2.       The case of the Complainant is that Richa Jain (for short, the ‘patient’) on 28.09.2012, underwent two laparoscopic surgeries at Fortis Flt. Lt. Rajan Dhall Hospital (for short ‘Fortis’ - OP-1). The first surgery of cholecystectomy was performed by Dr. Randeep Wadhavan. The second surgery was the laparoscopic removal of ovarian cyst, it was performed by Dr. Neema Sharma (OP-2). It was alleged that surgery was performed without investigation of MRI and CT Scan. Also the OPs did not do the tumor marker - Cancer Antigen 125 (CA 125) before the procedure. However, it was done on 29.09.2012 after the operation along with the biopsy of cyst particles. The Complainant was never explained about the nature and scope or the complication arising from the surgery. It was further alleged that during laparoscopic procedure, the ovarian cyst was ruptured intra-operatively and the tumor was spread over the reproductive organs. It was disclosed to the Complainant by the hospital on 05.10.2012 at the time of removal of stitches. The hospital sent the blood for CA 125 and the cyst fragments for histopathological examinations. The OPs-2 and 3, based on histopathology report, as high grade cancerous cyst of right ovary and the patient was advised to undergo Laparoscopic Hysterectomy to prevent further spread of cancer. The Complainant approached AIIMS for second opinion on 08.10.2013, wherein she was advised to undergo Chemotherapy. However, she underwent pan hysterectomy (removal of uterus, cervix and both the ovaries) on 22.10.2012 in Rajiv Gandhi Cancer Research Centre.  The Complainant got information under RTI about CA 125 and thus, therefore, she came to know that estimation of CA 125 was crucial before undergoing the surgery. The Complainant further alleged that the cyst was large, thus laparoscopy was not advisable, but it was done in haste. Therefore, due to negligence of OPs, the Complainant lost her uterus and the chance to reproduce a child, thus it was permanent emotional trauma. Being aggrieved, the Complainant filed the Consumer Compliant under section 21(A) (1) of the Consumer Protection Act, 1986 before this Commission for alleged medical negligence and prayed the compensation to the tune of Rs. 7.10 Crores from the Opposite Parties under different heads.

Defense:  

3.       The Opposite Parties filed their written versions and denied allegations of medical negligence. It was submitted that on 26.09.2012 the OP-2 examined the Complainant in the OPD for her symptoms of abdominal pain and persistent vomiting. Clinically it was right adnexal mass with severe tenderness suggestive of infection or rupture or torsioned ovarian cyst. The USG was reported as ‘ruptured dermoid cyst of ovary or hemorrhagic corpus luteal cyst or an extra-uterine pregnancy. All were   non-cancerous and the treatment was surgical removal of cyst by Laparoscopic or open surgery.  The benefits of both procedures were discussed with the couple and the laparoscopic procedure was suggested in the best interest of the patient considering her age, future fertility and speedy recovery. She was given ample time to decide the choice of method for surgery. The patient finally chose laparoscopic method and signed the consent form. The OP-2 submitted that CA 125, MRI and CT scan  were not advised because the malignancy was not suspected in the young patient. Moreover, the results have no impact on mode of treatment but it would have increased the cost of treatment. It was further submitted that the Complainant never disclosed her previous USG reports to OP-2. The Complainant under disguise filed RTI Application to AIIMS and got the reply by misleading AIIMS. Thus the Complainant shall not be allowed to use RTI reply as a tool for alleged negligence. The Complainant is so keen, she should have provided entire medical records to the Medical Experts of AIIMS and sought the opinion. The OPs- 2 & 3 were experienced and competent to remove bigger cysts through laparoscopic procedure. The Complaint is bad for mis-joinder of the parties; as such the Complaint was frivolous and vexatious.

Arguments:

4.       Heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record.

5.       Arguments on behalf of the Complainant

The learned Counsel for the Complainant reiterated their evidence.  He argued that the OPs failed to advise/perform CA 125 test prior to the surgery. According to the RTI reply from AIIMS, it was mandatory test to be performed before surgery. The learned Counsel relied upon the case Nizam Institute of Medical Sciences Vs. Prasanth S Dhananka and Others^[1].

6.       Arguments on behalf of the Opposite Parties (Nos. 1 to 3)

The learned Counsel for the Opposite Parties reiterated their written version and affidavit of evidence. The laparoscopic procedure was performed by Dr. Neema Sharma and Dr. Ramandeep Kaur, Senior Consultants in Gynaec since the ruptured cyst and consequential infection could have been life threatening. The Complainant was treated as per the accepted medical protocols. During laparoscopy, it was noted that the cyst already ruptured and pus like deposits were seen in the abdomen and straw colored fluid in the pelvic cavity. The cyst was removed in an Endo- bag as per standard procedure which is an accepted operative procedure worldwide.

Discussion:

7.       Admittedly, the OP-2 diagnosed the case as right sided adnexal mass and it was confirmed by USG report. The differential diagnosis of the ectopic pregnancy / torsion ovarian cyst was made and clinically it was non-cancerous cyst. Therefore in the best interest of the patient on considering her age, future fertility and speedy recovery the OP-2 advised resection of cyst.   At the time of OPD consultation, there was no reason to suspect any malignancy in view of her symptoms and young age as malignancy is very rare before age of 40 years and USG features also did not warrant. 

8.       In my view, the Patient was managed as per the reasonable standard of practice. The patients with ovarian cyst who come in emergency with pain are usually managed with antibiotics and early surgical intervention is preferred. To understand on the subject, I have gone through the Shaw’s textbook of Gynecology and Berek & Novak's Gynecology and few literatures, it revealed that:

• The reasons for Acute Lower Abdominal pain are Ovarian torsion, rupture Ectopic pregnancy, pelvic inflammatory disease, Tubo-ovarian abscess. Sonography is commonly used for easy diagnosis. Operative laparoscopy is the primary treatment for appendectomy, ovarian torsion, and for ruptured ectopic pregnancy or ruptured ovarian cyst. The Ovarian cancer typically is portrayed as a "silent killer" without appreciable signs or symptoms until advanced disease is obvious clinically[2].  
• In the evaluation of acute pelvic pain, early diagnosis is critical because significant delay increases morbidity and mortality. Surgical exploration is indicated if rupture of the cyst leads to hemoperitoneum or chemical peritonitis (endometrioma, benign cyst teratoma) which could impair future fertility[3].
• Ovarian cyst rupture occurs due to benign or malignant cystic lesions of the ovaries. Cyst excision is a convenient treatment choice in young patients. It is important not to remove the whole ovary[4].
• Laparoscopy plays an important role in the diagnosis and treatment of several conditions that causes acute pelvic pain, including EP, FID, tuboovarian abscess, and adnexal torsion

9.       Expert opinion of Dr. Urmil Sharma

Perused the opinion of Dr. Urmil Sharma - a Senior Emeritus Consultant in Indraprastha Apollo Hospital gave an opinion on affidavit that;

"4. Offering and performing a laparoscopy without a frozen section after starting her on antibiotics for a 27 year old recently married nulliparous women who presents with pain and ultrasound and TLC levels suggestive of a benign infective ruptured ovarian cyst is standard management in all the centers and is the standard of care today. A serum CA 125 level in these circumstances is expected to be, high in any case and does not alter management since it is a prognostic not diagnostic marker. MRI or CT scan is not the first line investigation in these circumstances and trans vaginal sonography is the most accurate test in assessing ovarian tumor size and morphology. Frozen section should not be offered to a young girl who is desirous of fertility because of its limitations. When in doubt, it is always more medically judicious to go back for more aggressive surgery after confirmation of definite evidence of cancer.

5. She has followed the standard practice guideline mentioned in the standard textbooks as annexed herewith (Williams Gynecology, Benigal General Gynecology and Berek & Novak Gynecology).

10.     Not advising CA 125 test before surgery whether it amounts to deficiency in service? 

According to the Standard texts and literature, it is known that;

• In general, levels of CA 125 in excess of 35 U/ml are considered to be abnormally high. Unfortunately, interpreting the results of the CA 125 test is not simple.
• Some doctors may recommend the CA-125 blood test to women with a strong family history of ovarian cancer. However, the test usually isn’t used to screen for ovarian cancer in women who have an average risk of developing the disease. Thus CA-125 test isn’t accurate enough to screen for ovarian cancer in all women.
• Besides cancer, there are numerous disorders and conditions that can cause elevated CA-125 levels. The significance of an elevated CA 125 level is not always straightforward. Elevated CA 125 levels can be caused by events such as pregnancy, menstruation, pelvic inflammatory disease,  liver disease, uterine fibroid or endometriosis.For these reasons, the doctors don't recommend CA 125 testing in those with an average risk of ovarian cancer. The risk might be high if the genes (BRCA1 and BRCA2) that increase the risk of breast and ovarian cancers if there is family history. 

11.     More often, CA - 125 is not used as a diagnostic tool but as a prognostic marker. CA 125 is not a diagnostic or confirmatory test for cancer[5]. According to few literatures, the level of CA 125 was expected to show high level because of rupture of ovarian cyst and fluid in the peritoneal cavity and the associated infection[6]. It is also stated that CA 125 cannot be used for diagnosis, as CA 125 is falsely and erroneously raised with infections and ruptures. It can lead to mistaken suggestion of malignancy, not confirmation[7]. It is known that CA 125 is increased by non-gynecologic malignancies with involvement of the pleura or peritoneum and by benign conditions that result in ascites. Because of many medical diagnoses that give false positive CA -125 results, thus it cannot be used as a diagnostic tool[8]. The CA 125 is used as a base line test to follow up response to treatment in cancer that is why it is known as a prognostic marker of disease outcome because if after treatment the level drops it indicates response to treatment, and if it rises it indicates failure of response and progression of the disease.[9]

12.     In the instant case I do not find any deficiency in service of the OP-2. The ovarian cyst was already ruptured before the surgery, therefore, the line of treatment would not changed even if CA125 estimation was not done. There was no reason for OP-2 to suspect malignancy during OPD consultation. As the patient was young, having pain and rarely malignancy suspected below age of 40 years. Even USG findings were not suggestive of malignancy. Usually the patient with cancer are asymptomatic, rarely get acute pelvic pain, until it reaches grade – III or IV cancer. The laparoscopic procedure was approved standard procedure for benign or malignant cyst and the OPs were capable of performing the said procedure.

13.     The Complainant’s contention was that MRI and CT Scan should have been performed before laparoscopy. In the instant case, the patient underwent Trans Vaginal Sonography (TVS) for accurate assessment of size and morphology of ovarian tumor, thus, MRI or CT Scan was not needed.

14.     The next question is whether the biopsy during surgery i.e. frozen section could have helped? In my view, there are limitations of frozen section results, which may not be 100% accurate. Also keeping in mind the young age of the Complainant and already ruptured cyst, conducting frozen section and proceeding for aggressive cancer surgery was not advisable. According to the textbook of Telinde's Operative Gynaecology 10^th Ed. :

"One should not rely too heavily on frozen section in making the decision to perform a hysterectomy and bilateral salpingo-oophorectomy. If the histologic diagnosis is in question, it is always preferable to wait for permanent section results for a younger patient, even if this requires a repeat surgery."

Moreover, the frozen section in presence of infection and hemorrhage is not a reliable and it may give false negative results, thus, in my view, the OP-2 has correctly not taken hasty decision under emotional circumstances.

15.     I further note that the OP-3 was unnecessarily impleaded in this Complaint.  She is a Director of Department of Gynecology, Minimal and Natural Access Gynae and Gynae Cancer Surgery and Gynae Robotic Surgery. She has vast clinical experience and   expertise. She saw the patient twice only. Firstly as in-patient as a case of high grade Endometrial Adenocarcinoma and advised whole abdomen MRI with contrast, tests of CA125 and CA 19.9 as required for a base line for the treatment. She also advised plan for laparoscopic hysterectomy. The second consultation was on 16.10.2012 after review of HPE report and discussion with the tumor board. She planned the patient’s treatment with possible neoadjuvant chemotherapy as per the NCCN guidelines.

16.     I would like to rely upon the decision of the Hon’ble Supreme Court in Kusum Sharma Vs. Batra Hospital[10], which laid down the guidelines to govern cases of medical negligence and held:

"89. On scrutiny of the leading cases of medical negligence both in our country and other countries, especially United Kingdom, some basic principles emerge in dealing with the cases of medical negligence. While deciding whether the medical professional is guilty of medical negligence following well known principles must be kept in view:

          ….. xxx……

(v) In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of other professional doctor.

(vi) The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he

honestly believes as providing greater chances of success for. the patient rather than a procedure involving lesser risk but higher chances of failure. Just because a professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence.

(vii) Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession."

17.     Based on foregoing discussion, in the entirety I do not find any failure of duty of care or any deviation from the accepted standard of practice. The diagnosis and mode of treatment adopted by the doctors was correct; it was based on the patient’s age, clinical examination, symptoms. Thus, negligence is not attributable to the opposite parties. The Complainant failed to prove her case, the same is dismissed.

There shall be no Order as to costs.