Background in Brief
That Complainant No.1 Renu Saini was a high risk case in view of her past history of previous 3 caesarean section, multiple D & E procedures, presence of invasive vesicular mole not responding to medical management (Methotrexate, a chemotherapy agent) and presence of comorbid conditions like hypothyroidism and obesity. Considering high risk factors, the treating doctor Party No. 4 Dr Shallu Kakkar involved Party No.5 Dr Naresh Kumar Soni, a specialist in onco-surgery in the operation of Complainant No.1 Renu Saini. Complainant No.1 Renu Saini was taken for surgery after appropriate informed consent and thorough counseling.

During the surgery of Complainant No.1 Renu Saini, the important structures/organs like ureters, bowel, urinary bladder were safeguarded under direct vision, however part of the urinary bladder wall had to be excised to achieve complete clearance of the disease, (Failure to do so would have resulted in inadequate treatment of Complainant No.1 Renu Saini). Following this, Party No.4 Dr Shallu Kakkar and Party No.5 Dr Naresh Kumar Soni promptly called Dr Sandeep Gupta, a Urology specialist, who deals with such situations. Dr Sandeep Gupta performed a thorough exploration of the system as per the standard medical protocol to deal with such kind of urinary bladder injury, occurring intra operatively, which is a known possible complication of this type of surgery in medical science.

As per the standard urological text books recommendation, Appellants and Dr Sandeep Gupta, identified and traced both the ureters (including checking of the integrity and patency of the ureters in an opened urinary bladder as per standard protocol) then repaired urinary bladder.

The judgment in this case was based on the conclusion that the operating surgeons did not exercise due caution in preventing a known complication of this operation. However, the judgment is not based on any cogent finding but merely on the presumption that the operating surgeons were aware of the complication (urinary bladder injury) yet did not prevent it because they did not exercise due caution.

This was a high-risk, complicated case of choriocarcinoma of the uterus that had spread out and invaded the urinary bladder. A surgical procedure of open abdominal total hysterectomy with bilateral salpingio-oopherectomy (removal of uterus with its two tubes and ovaries) was done. The surgeons were aware that during the procedure one or both ureters and/or the urinary bladder could be injured. Hence, a fully informed, high- risk consent taken during which process the patient was told of the possibility of such an injury occurring despite the best efforts of the surgeon to exercise due care.

The Commission's finding was that the surgeons:

1. took the consent as a 'license' to cause the injury,
2. they lacked the appreciation, understanding and comprehension of the complex technical details of the surgical procedure and
3. they lacked even a basic knowledge of the anatomical details of the uterus, the course of the two ureters in the pelvis and their structural relationship to the uterus, that rendered them vulnerable to injury in the operation of hysterectomy.

This was compounded by the Commission's decision to bar, on technical grounds, the defendant counsel from placing the evidence. The Commission, in its wisdom, did not consider it necessary to call independent experts to interpret the medical evidence placed by the complainant and controverted by the defendant in its reply. Interpretation of fragmented narrations, frequently out of context, together with cut-and-paste information from medical literature, led the Commission to conclusions that were, at best, conjectures.

The judgment begins with abstracted details of the disclosure of risks of the procedure (injury to urinary bladder etc.) in the informed consent taken. The legal requirement of informed consent is disclosure of the procedure proposed to be performed and the risks involved (adequate disclosure) and in a language understandable by the patient (patient autonomy). Legally, free and voluntary consent given after understanding the risks results in the patient assuming the risk. The Commission unfortunately interpreted the form and contents of this valid, informed consent as a license to inflict injury.

Interpreting the operative procedure from the operation note etc the Hon'ble Commission findings/observations and the evidence on record is:

Judgment A. After the operation urology related problem was encountered

Author: In fact the problem was not encountered after the operation. The urological problem � urinary bladder 'injury' - was a part of a required resection of the involved bladder.

Judgment: B. The womb was very large and the bladder, ureter etc were adhered.

Author: The uterus was not adhered to (which would have needed separation) but the cancer had come out of the uterus and involved the bladder - the involved part of the bladder had to be removed. The ureter was NOT involved, operative note does not say so.

Judgment: C. Bladder, ureter etc were adhered � should have been first separated and then the uterus should have been removed.

Author: The part of the bladder involved by the cancer had to be removed along with the cancerous part of the uterus. What is done in classical hysterectomy was not applicable in the present context. It is again pointed out that the ureter was not involved and did not constitute the part of the bladder removed.

Judgment: D. As per the operation note while separating the bladder it got injured.

Author: This is contrary to the facts (operative notes) on record. The bladder was not incidentally injured while 'separating' it from the uterus but was deliberately removed being cancerous.

Judgment: E.Uureter was separated but no ilaj (treatment) was done. Neither test was done injecting a dye to test whether the ureter was working or not.

Author: This is again contrary to the facts on record (operative note of the urologist). Part of the bladder having been removed by the onco-surgeon and Gynecologist it was open. The uro-surgeon examined the interior of the bladder through the opening. He identified the openings of the two ureters. Urine was noted to be coming out from both ureteric orifices. The uro-surgeon introduced thin tubes through the openings of ureters. Threaded them and physically verified that there was no breach in the integrity of the two ureters. He also verified it by flushing the ureters. This is the standard procedure. No dye injection test was needed or indicated. After verifying the structural integrity of the two ureters the uro-surgeon removed the tubes introduced in the ureters and closed the opening in the urinary bladder and left drains to keep the bladder deflated till the repaired breach in the bladder had healed.

Prefacing the interpretation of the Surgical Technique and procedure the Hon'ble Commission records its knowledge and understanding of the ureter etc.

Judgment: F.Ureter is an organ in the abdomen that carries urine from the kidney to the bladder. They are two for the two kidneys. One for right kidney and one for left kidney. All this is concerned with right kidney and right bladder. (Ureter is a sort of a tube that is made of smooth muscle fibers. Its length is 25 to 30 cm i.e up to 10 to 12 inches and its width is 3-4 mm i.e 0.12 to 0.16 inches. Its interior through which urine passes is of the size of a kite thread. Mishandling it may cause it to collapse or puncture. It was the duty of Dr. Sandeep Gupta that by injecting a dye he should have tested whether it was working or not.)

Author: The Hon'ble Commission's perception and understanding of the ureter is woefully inadequate to interpret the highly technical nature of the operative procedure performed. What is relevant in this context is course (passage) of the two ureters in the female pelvis and its close proximity and relations to ovary, uterus and vagina that render it vulnerable to injury in the different stages of the surgical procedure.

The ureter, as it descends into the female pelvis, comes in close relation to the ovary. To avoid injury to the ureter while removing an ovary (oopherectomy), cautions are prescribed as an integral part of the operation. The ureter then descends in the lateral wall of pelvis where it is in close contact with several structures including lymph nodes. Where lymph nodes are removed as a part of surgery for high grade cancer, the two ureters are dissected and traced in its entire course before taking steps to remove the uterus.

Here one of the cautions prescribed is do not do a very close dissection of the ureter, do it outside the fibrous sheath with which it is surrounded. The anticipated danger here is that close clearance of the ureter may injure the thin blood vessels that supply it thereby causing avascular necrosis of part of a ureter. From the lateral wall of pelvis as the ureter travels to uterus, it comes in close relation and is crossed by the uterine artery. The ureter here also travels through a dense fibrous ligament that has to be cut to remove the uterus. Cautions are prescribed to avoid ligation or cutting of the ureter while ligating the artery. The ureter then comes in close relation to the upper part of vagina and the cervix of the uterus.

Cautions to avoid injury to this part while cutting open the vagina and suturing it are also integral part of the surgical technique. The terminal part of the ureter is in the muscle of the urinary bladder (intramural part) as it tunnels through the bladder musculature to open in the bladder. Cautions are prescribed in the surgical procedure performed on the urinary bladder. (It is this intramuscular part of the right ureter that developed slow and asymptomatic constriction and obstruction, incidentally found on checkup USG almost 6 months after surgery).

The different types of 'injuries' � cut, ligation, devascularisation, stricture etc, alluded to in the latter part of judgment, can not be clubbed as single entity for assessing the injury to a specific part of the ureter. All the specific cautions prescribed are part of the surgical technique of Total Hysterectomy with Bi-lateral Salpingio- Oopherectomy.

A surgeon imbibes and adopts the same during his training. There is no finding elucidated by the Commission that the prescribed cautions were not adopted in the surgical technique to operate upon the patient. All the three surgeons possesed knowledge and skill (Competence) to perform the surgical procedure. They have been trained in performing the surgical procedure and had the detailed knowledge of the anatomical details, possibility of injury, vulnerability and the surgical technique to exercise caution to avoid injury to the ureter.

The fact that NO cut, ligation, devascularisation or crushing of any part of the pelvic ureters Occurred is proof positive that the surgeons had performed with all the technical cautions prescribed. The Commission erred in arrogating to itself superior knowledge and understanding of the technical skill required to perform the surgical procedure.

The Hon'ble Commission repeatedly states in its order that the operating surgeon by not testing the integrity of the ureter by introducing a dye committed the negligence.

The fact is that Dr. Sandeep Gupta had tested the integrity of the two ureters by threading through two tiny tubes through the opening of ureters and flushing them with saline. The ureters were neither adhered (chipki) or collapsed (pichki). It is strange on part of the Commission to infer that 'stent' should have been put in the present case and situation, and the surgeon erred in not doing so. Obviously the knowledge when, why, in what conditions and how a stent in ureter is placed, was lacking. Placing a stent in the ureter can not be a matter of conjecture.

There is no basis to infer that the patient's right ureter was 'blocked' during the operation and the urine stopped coming through it from the kidney. The right ureter was not blocked. On examination by the Uro-Surgon urine was coming out through the mouth of both the ureters. Thin tubes threaded through the mouths of the two ureters had revealed no such blockage. The inference that the intramuscular part of the right ureter was blocked while performing hysterectomy, is patently incorrect and unsubstantiated. Had the right ureter been completely blocked in operation it would have resulted into immediate damage to the kidney and not 'slow swelling' and damage of the kidney. This was effectively pointed out in the reply submitted.

There is no basis to presume that the three superspecialists individually and collectively lacked in 'skill' and 'sawdhani' during operation on the patient. There is no ground to doubt the surgical competence of the three specialists.

Factually incorrect. No cogent findings. Pure conjectures and ill based assumptions and presumptions.

The stricture developed in terminal part of one ureter was a totally independent occurrence. Why a stricture developed? What caused it? Why it so slowly progressed to remain asymptomatic for almost 6 months? Is a matter of expert investigation and evaluation? The presumption that it was caused by negligently done hysterectomy is baseless.

Little knowledge is dangerous and arrogance of ignorance is worse. Complex medical matters are not safe � for patients and medical professionals both � in such hands, especially where it is matter of summary trial.

Where ignorance is (self serving) bliss it is folly to be wise.

The Hon'ble Commission states in its order:

Judgment: G. It was duty of Dr.Sandeep Gupta to have tested by injecting dye to asses whether the ureter was functioning or not? If it was adhered (chipak) at some part he should have put a stent at that part so that it did not collapse (pichak).But Dr.Sandeep Gupta did not do it. He only inspected it from outside that the ureter not injured. If there were leakage outside of urine, it would have automatically revealed a puncture, and the kidney damage that was found out after 6 months, the kidney would not have been damaged. The ureter would have been treated and the question of leakage would not have arisen.

Author: The fact is that Dr.Sandeep Gupta had tested the integrity of the two ureters by threading through two tiny tubes through the opening of ureters and flushing them with saline. The ureters were neither adhered (chipki) or collapsed (pichki). It is strange on part of the Commission to infer that 'stent' should have been put in the present case and situation, and the surgeon erred in not doing so. Obviously the knowledge when, why, in what conditions and how a stent in ureter is placed, was lacking. Placing a stent in the ureter can not be a matter of conjecture.

Judgment: H. The complainant was operated upon and closed. She remained in the hospital for 7 days, kept complaining of pain in abdomen, back ache on right side, fever, unease (ghabhrahat) no serious attention was paid to it. While it reveals that during the operation on complainant the right ureter was damaged (kharab), the urine that goes from the kidney to the bladder stopped, the kidney started swelling and slowly the right kidney got damaged, so much so that there was no alterative to its removal. All these facts have been established by her medical record and after discharge record and affidavit.

Author: This is factually incorrect. The allegations of neglect in post operative period of stay of the patient has been controverted in the reply and substantiating documents submitted.

There is no basis to infer that the patient's right ureter was 'blocked' during the operation and the urine stopped coming through it from the kidney. The right ureter was not blocked. On examination by the Uro-Surgon urine was coming out through the mouth of both the ureters. Thin tubes threaded through the mouths of the two ureters had revealed no such blockage. The inference that the intramuscular part of the right ureter was blocked while performing hysterectomy, is patently incorrect and unsubstantiated. Had the right ureter been completely blocked in operation it would have resulted into immediate damage to the kidney and not 'slow swelling' and damage of the kidney. This was effectively pointed out in the reply submitted.

There is no basis to infer that the patient's right ureter was 'blocked' during the operation and the urine stopped coming through it from the kidney. The right ureter was not blocked. On examination by the Uro-Surgon urine was coming out through the mouth of both the ureters. Thin tubes threaded through the mouths of the two ureters had revealed no such blockage. The inference that the intramuscular part of the right ureter was blocked while performing hysterectomy, is patently incorrect and unsubstantiated. Had the right ureter been completely blocked in operation it would have resulted into immediate damage to the kidney and not 'slow swelling' and damage of the kidney. This was effectively pointed out in the reply submitted.

Judgment: I. In conformity of the norms laid down by the Hon'ble Supreme court, the onus is on the respondents to prove that there was no indiscretion or negligence and that they treated with all the required skill and caution. Fortis hospital is superspeciality hospital. Superspecialist doctors work in it and heavy fees and charges are realized from the patient, therefore, it is the duty of the doctors to treat the patient with full skill and caution.

Author. There is no basis to presume that the three superspecialists individually and collectively lacked in 'skill' and 'sawdhani' during operation on the patient. There is no ground to doubt the surgical competence of the three specialists.

Judgment: J. Perusal of the aforesaid norms laid down by the Hon'ble Supreme Court and Hon'ble National Commission, would reveal that it was duty of the respondent exercise full skill and caution in the treatment and the onus to prove it was on the opposite party. Apart from the reply the respondents have not placed any evidence.

The opposite parties have failed to discharge there burden to prove it. In the instant case there is no need of specialist as most of the facts are accepted or that are present in the treatment records of the other hospital. In any case, in a civil suit there is no need of evidence by a specialist.

Author: The Hon'ble Commission had barred the defendants from doing the same on flimsy technical grounds and arrogated to itself the role of a Super-Super-Specialist to arbiter technically complex medical matter without seeking any assistance from medical experts (opinion), even of the experts who later treated the patient.

Judgment: K. In this case the ureter got injured during operation, though the same has not been clearly stated by the respondents, only bladder injury has been shown. But if the ureter was functioning properly urine from right kidney would have continued to drain in the bladder. No complication would have occurred. The complainant had antecedent diseases of which the respondents were aware. However, no caution was exercised. Even while admitted to the hospital the complainant made several complaints but the same were not properly investigated. So much so that the patient complained of pain in the right side of her back but no proper examination was done. Opposite party was negligent.

Author: Not based on any cogent finding. Purely conjectural.

Judgment: L. As per the available record the complainant had cancerous tumor of the uterus. Uterus was swollen and ureter and bladder were adhered to it which were to be separated before removing the uterus. The urologist while separating injured the bladder. It was repaired. The damage to the interior of the ureter could have been assessed by a dye testwheter. the right ureter that connects kidney with urinary bladder is functioning properly or not. Ureter which was adhered to uterus was separated, the space in its interior that exists is very narrow to allow onward passage of urine. Ureters width is just 3-4 mm and its interior is wide enough to admit a thin kite-thread. If a stent had been put there would have been no obstruction. Because of obstruction in it the urine slowly stopped to coming to the bladder. The complainant patient did not have any difficulty because her left kidney and Ureter were functioning. Because the right Ureter was not functioning, the right kidney swelled up and gradually, sort of, completely stopped functioning. There was no alternative to its removal, and it was removed. Thus the complainant has successfully proved her allegations.

Author: All the points repeated here have already been answered.

Judgment: M. In olden times there used to be one type of surgery, in which the part to be operated upon was fully opened and corrected. Presently there are two types of surgeries, one laparoscopic through a durbin (scope) and another an open surgery. When the surgeon is certain, all the organs are clearly visible on the screen, and there is no complication, then by a laparoscope, in 2-2 stitches holes are made, the scope is introduced, seeing on the screen the cutter that had been introduce d is used to cut what needs to be cut and repaired and no cutting is needed it is directly repaired. Thus there are no complications and there is no danger of excessive bleeding, The patient is discharged on second or third day. Second type is where the part to be operated upon is laid open so that every thing is in direct vision and by surgery it is correctly united.

Author: What a knowledge of laparoscopic surgery versus open surgery! And it is on this knowledge that the complicated hysterectomy surgery done by three specialist surgeons have been judged. The Commission has strange notions about the techniques of Laparoscopic and Open operations and of technical details of the complex surgical procedures.

Judgment: N. In this case open surgery was done on the complainant as there were complications in the operation. All organs had to be directly seen. The part to be operated upon and the part to be removed should have been properly done. Ureters were adhered to bladder and uterus, which were to be first separated and then only the uterus should have be removed. This was possible on open surgery, there was high risk therefore, consent was taken twice, with possibility of injury to parts other than the uterus and also for removing other parts should it be found necessary. But the consent did not mean that the surgeon could operate in any manner he wanted. Due skill and care was not exercised. It it caused grat pressure and duty on the surgeon.

Author: It is audacious on part of the judge to presume that the three trained specialist surgeons who had done this surgery regularly lacked even the basic knowledge of the surgical procedure and that they lacked in skill and care. His knowledge of the type of skill, care and caution required in required in complicated hysterectomy cases is woefully inadequate. He lacks basic medical knowledge to judge such a complicated surgery.

Judgment: O.Open surgery was done on the complainant. If just uterus was to be removed laparoscopic surgery could have been done. But the uterus was open, Ureter and bladder were adhered. Also, so that those nearby organs that could have been partly involved in cancer were visualized open surgery was done. High risk consent was taken from the complainant which shows that the operation was dangerous. Taking consent twice does not give license to operate without applying mind and without exercising due caution. On the contrary it was a warning to the operating super specialists that they should have exercised skill in conformity to their respective specialties. The second surgery performed on the complainant to remove kidney was not a high risk surgery. The kidney and the ureter were removed laparoscopicallly and the that part of the bladder was closed which shows that the surgery was quite risky.

Author: The bladder was not adhered but involved in cancer. Interpreting high risk informed consent to be a license to recklessly perform a high risk operation is, to say the least presumptuous.

Judgment: P. Only one kidney of the complainant was functioning. Damage of this could have been life threatening to the patient. If both kidneys were functioning she could have donated one to a needy person and save a life.

Author: Needs no comments.
Judgment: R.In this case Dr. Shalu Kakkad and Dr.Naressh Soni had both seen the complainant and taken a decision to operate. And both had take high risk consent twice. At time of operation both the surgeons knew that the bladder and the ureter were adhered to the uterus but they operated on the patient without calling the urologist. When complications arose they called the urologist, who then separated the bladder a.nd the Ureter. Subsequent part of the surgery was done by Dr. Shalu Kakkad and Naresh Soni. Post operative as long as the patient stayed in the hospital she was looked after these two doctors. The discharge ticket bears the signature of Dr. Shalu Kakkad and Dr. Naresh Soni. It is not signed by Dr.Sandeep Gupta, who therefore bears no responsibility. Respondents 1to 5 are individually and collectively responsible.

Author: Not a correct narration of steps of operation and the respective roles of the three surgeons.

Judgment: S. Now the question how much compensation should be given to the complainant. She must have paid large sums to the Fortis Hospital. Later she received treatment from Dr.S.K.Sharma and Dr. M.R.Roy, where also they must have incurred heavy expenditure. She got her kidney removed by Dr. K.K.Sharma, here also she must have incurred expenditure. Now the complainant is with one kidney. She has been a cancer patient and has also undergone chemotherapty and radiotherapy. It is possible she may develop adverse effects.

Author: Reflects bias and prejudice as the complainant had asked for only the balance amount not paid by the insurance company.

Author: All findings factually incorrect. No cogent findings. Pure conjectures and ill based assumptions and presumptions. The Commission has strange notions about the techniques of Laparoscopic and Open operations and of technical details of the complex surgical procedures. (See earlier parts).

Little knowledge is dangerous and arrogance of ignorance is worse. Complex medical matters are not safe � for patients and medical professional both � in such hands, especially where it is matter of summary trial.


Written By: Dr. Shri Gopal Kabra
MBBS, LLB, MSc, MS(Anatomy), MS(Gen. Surgery)
!5, Vijay Nagar, D-Bock, Malviya Nagar, Jaipur- 302017
Ph no: 8003516198