PER JUSTICE R.C. JAIN, PRESIDING MEMBER

             The above named complainants have filed this complaint alleging medical negligence and deficiency in service on the part of the opposite party-Hospital and Doctor in the treatment of complainant No.1-Smt. Tilat Chaudhry and have claimed compensation of Rs. 30,58,923/- from them under various heads.

2.          In nut shell, the case of the complainants is that complainant No.1 is the wife of complainant No.2.  They are ordinarily based in Lucknow.  In February, 1997, the complainant had complaint of pain in her abdomen and after consultation with local doctors and radiological and other investigations, she was diagnosed as having stones in the Gall Bladder and was advised surgery for the same.  Going by the high reputation of opposite party No.1-All India Institute of Medical Sciences, the complainants approached the said hospital in March, 1997 and after the complainant No.1 was examined by certain doctors, she was advised to undergo laparoscopic cholecystectomy, which would normally require hospitalization of 3-4 days in all.  On 25.3.1997, the complainant No.1 was admitted in AIIMS in the private ward of AIIMS after paying the requisite charges and laparoscopic cholecystectomy was conducted on her in the morning of 27.3.1997 by opposite party No.2-Surgeon.  As it took unusually long time to conduct the procedure, the complainant No. 2 became suspicious.  Complainant No.1 was shifted to her room only in the morning hours of 28.3.1997 when it was noticed that her entire abdomen had been stitched.  When the Complainant No.2 wanted to enquire from O.P. NO.2, he snubbed him.  According to the complainants problem of complainant No.1 increased and new troubles erupted after operation.  She was discharged from the hospital on 04.4.1997 in a very bad condition with fever, excessive pain, shivers, vomiting etc.  From the discharge summary received by the complainant, it was revealed that some injury was caused to the bile duct during laparoscopic procedure and to repair the same, the abdomen of the complainant No.1 was opened and false excuse was given for covering up the said mistake, which was caused due to the negligence and carelessness of opposite partyNo.2 and other assisting doctors.  It is alleged that not only that the injury to the bile duct was caused but it was not repaired promptly and properly, which resulted into further complications.  After her discharge from the opposite party No.1-hospital, the complainant No.1 consulted other doctors at Delhi, Patna and Lucknow who tried to treat the complainant No.1 through medicines at a huge cost.   Even then, the level of Alkaline Phosphate increased in the body of complainant No.1 as was found after Neuclear Medicine test at Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow (fort short ‘SGPGIMS’) and it was found that there was blockade in the body of the complainant No.1, which prevented free passage of bile and raised alkaline phosphate which was due to the faulty repair of the bile duct injury.  Despite taking treatment at various medical centers, there was not much improvement in the condition of complainant No.1 and she was advised to undergo second surgery, which could pose a risk to her life.  It is alleged that due to residual defect / disability, the family life of the complainant has also been ruined and the complainants are unable to perform their duties and pursue their social and political activities.  Complainants have therefore, claimed a compensation of Rs. 30,58,923/- under the following heads:

1.  Expenses at AIIMS:

    (i)  Payment of bill                                                :                       Rs. 11,785.00

    (ii) Purchase of medicine and

        Things of surgical need around                    :                       Rs. 30,000.00

2. Expenses incurred in tests, medicines,

    Fees of doctors etc. at Delhi, Patna and

    Lucknow between two operations                    :                       Rs. 35,000.00

3. Expenses in SGPGI, Lucknow during

    Second operations:

(i)            Payment of bills                                       :                       Rs. 17,138.00

(ii)          Purchase of medicines and

Things used in surgery around                        :            Rs. 30,000.00

4.  Expenses incurred in tests and medicines

     After the operation of SGPGI till date around                        Rs. 10,000.00

5.  Expenses incurred in travelling, conveyance

     And miscellaneous expenses around                        :                       Rs. 25,000.00

6.  Expenses incurred in travelling

     Abroad                                                                  :                       Rs. 2,00,000.00

7.  Compensation for deprivation from

     Leading normal life in past and future

     And reduction of life expectancy of

     Complainant No.1 due to two operations

     During short time                                                :                       Rs. 15,00,000.00

8.  Compensation for mental agony

     Suffered by complainants and physical

     Pain and sufferings                                           :                       Rs. 10,00,000.00

9.  General compensation                                      :                       Rs. 2,00,000.00

                                                                                                            ______________

     Total                                                                                              Rs. 30,58,923.00

                                                                                                            ______________

3.          On being noticed on the complaint,  the opposite parties contested the complaint by filing a joint / common reply raising preliminary objections about the maintainability of the complaint on the ground that the opposite parties have not obtained any services charges from the complainants.  It is sought to be explained that the amount charged by opposite party No.1 was towards private room, special diet and other clinical diagnoses on subsidized rates.  It is stated that the opposite party No.1-Institute is of National importance, having laudable objects and reasons established to impart professional competence among medical practitioners and to provide teaching facilities of high standard in imparting medical treatment to the persons suffering from severe complicated deceases.  It is also stated that the complaint is liable to be rejected in view of the applicability of legal maxim ‘Volenti non fit injuria’.  On merits, it is not denied that the laparoscopic cholecystectomy was conducted by opposite party No.2 on the complainant No.1 at opposite party No.1-hospital and that during the course of the procedure an injury was occasioned to the bile duct of complainant No.1.  However, it is sought to be explained that the alleged injury (defect) is incidental and commonly accepted phenomena to such surgeries, which was assented to by complainant No.2 and therefore, no liability can be enfastened on the opposite parties.  The complaint is stated to have been filed with ulterior motive and after the limitation period as prescribed under Section 24-A of the Consumer Protection Act, 1986.  In this regard, it is pleaded that the surgery was conducted on the complainant No. 1 on 27.3.1997 and she was discharged from the opposite party No.1-hospital on 4.4.1997 and therefore the complaint filed in July, 1999, is barred by limitation.  It is however, denied that there was any negligence or carelessness on the part of the opposite party No.2-Surgeon in conducting the surgery of the complainant No.1 and on the other hand, it is maintained that opposite party No.2 is a renowned and experienced surgeon.  As regards the procedure, it is pleaded that the opposite party No.2 operated complainant No.1 with utmost care and ability and that while removing the stones from the gall bladder through laparoscopic procedure the surgeon encountered with a situation when it became eminent for him to convert the laparoscopic procedure into open / conventional cholecystectomy procedure. As regard  the consequential blockade of bile, it is stated that this also is a phenomena whereby the Billo-enteric anastomosis gets obstructed after repair, this related to the nature of healing of the complainant and had nothing to do with the skill of the doctor.  It is explained that the level of Alkaline Phosphate was normal on 03.4.1999 i.e. a day before she was discharged from opposite party No.1-hospitalon 4.4.1997.  It is denied that the opposite parties are liable for any medical negligence or deficiency in treatment of complainant No.1 or liable to pay any compensation for the same much less the compensation sought by the complainants.

4.          In the rejoinder, the complainants have controverted the objections and pleas raised in the reply of the opposite parties in regard to the maintainability of the present complaint before the consumer fora and have generally reiterated and maintained the averments and allegations already made in the complaint.

5.          To substantiate their claim, complainants have mostly relied upon the documentary evidence i.e. the record of the diagnosis and medical treatment of complainant No.1 at O.P. No.1-AIIMS and subsequent treatment, which the complainant received at SGPGIMS, Lucknow and hospital at Patna etc.  Besides the complainants have filed their affidavits, from the side of the opposite parties,  affidavits of Dr. D.K. Sharma, Medical Superintendent, AIIMS has also been filed on behalf of the opposite party No.1-Hospital  besides the affidavit of O.P. No. 2, Dr. T.K. Chatopadhyay, Prof. & Head Department of G.I. Surgery, AIIMS, New Delhi has been filed.  Complainant had also served a set of interrogatories on the opposite parties which were duly replied by them.

6.          We have carefully gone through the entire evidence and material produced on record and have heard complainant No.2 in person on behalf of the complainants and Mr. Anchit Sharma on behalf of the opposite parties and have considered their respective submissions.  As noted above, it is not disputed and even otherwise it is established from the medical record and the discharge summary of complainant No.1 from O.P. No.1-Hospital that CBD injury was caused during the procedure of laparoscopic cholecystectomy and procedure was converted to open cholecystectomy upon detection of the CBD injury.  Whether the CBD injury is a known complication of laparoscopic cholecystectomy procedure or it was caused due to lack of care / negligence on the part of the operating surgeon (O.P. No.2) and his team assisting doctors is the material question, answer to which would decide the fate of the present complaint.  According to the complainants, CBD injury was caused due to negligence of the operating surgeon and assisting doctors at the time of conducting the said procedure.  For this, we may first consider the various observations / findings as recorded in the operation notes and the discharge summary of complainant No.1:

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI – 110029

Name  Mrs.Talat Choudhary          Age 52                        Sex : F                        Marital Status            CR No.495592

Service:   Surgery –III          Ward : Pvt.II Bed : 203        Occupation     Religion

SURGERY UNIT – III

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

DISCHARGE SUMMARY

Follow up on Friday at 2.00 p.m. in R.No. I.V.Floor OPD Block

Name  :             Talat Choudhary    Age 52                        Sex : F                        CR No.495592                       FUC No.

Address : 169 Zakir Marg, Okhla Road,    D.O.A. : 25/3/97         D.O.O.: 27/3/97

                 New Delhi – 25

                                                     D.O.D.4/4/97

DIAGNOSIS :           Cholelithiasis

ADVICE

                        T.Flexon 1 – SOS

                        T.Rantac 150 mg – HS x 10 days

                        To Report SOS

                        To Attend Surgery-III FUC on Friday 2.00 p.m.

                        To Attend Gynae OPD for Cystocele and uterine prolapse

HISTORY &  PHYSICAL FINDINGS :   Pain (Rt) Hypochondrium x 2 yrs. Retrosternal burning x 2 yrs. Patient asymptomatic before 2 yrs when she developed pain right HC. Pricking nature, mild – moderate, few minutes, increased frequency in last 2 months. Now almost daily. H/o retrosternal burning sensation x 2 yrs mold to moderate increased after heavy / spicy meals

Diagnosed – cystocele = Uterine Prolapse X 2 months ago

O/E     - Vitals –WNL, GPE-NAD, Chest /CVS-NAD, Abdomen-NAD

OPERATIVE PROCEDURE & FINDIGNS:

            Laparoscopic – converted to open cholecystectomy + Hepaticojejunostomy under GA on 27/3/97

            Finding : normal  size gallbladder with unclear ductal anatomy – led to CBD injury-converted to open & Roux en Y Hepaticojejunostomy done.

HOSPITAL COURSE :       Uneventful. NG Removal PODI, Passed flatus POD3, orally allowed POD3 Passed Stools POD4, Drain out POD6, sutures out POD8. On discharge, patient afebrile, taking fully orally, wound healthy.  LFT-WNL.

7.          From the above notes and discharge summary, it is manifest that the CBD injury was caused and detected during the Laparoscopic dissection procedure and therefore, the said procedure was converted into open cholecystectomy to correct / rectify the said complication i.e.  Roux en Y Hepatiicojejunostomy was done in 4 layers using vicryl  3/0 and Hemostasis achieved.

8.          At this stage it is pertinent to note that going by the main plea of the complainant that given  the condition of the complainant No.1, the opposite parties should not have resorted to the laparoscopic procedure and that CBD injury was caused due to non-visualization of the ductal anatomy of the complainant No.1 during the laparoscopic cholecystectomy procedure and since the CBD injury during the laparoscopic procedure was not denied from the side of the opposite parties, this Commission, with a view to sort out the controversies thought it advisable to obtain the opinion from an independent medical expert body.  Normally, this Commission had been obtaining the opinion of the Medical experts of All India Institute of Medical Sciences in other cases of medical negligence but since in the case in hand, the AIIMS and its doctor were parties and the allegations of medical negligence and deficiency in service in the treatment were made against them, this Commission vide an order dated 16.1.2012 referred the matter to the Director General of Health Services, Government of India, New Delhi for constituting a Medical Board from the relevant discipline(s) not less than three in number and not belonging to AIIMS for the purpose of examining the matter and giving its expert opinion in the case in hand on the above aspect.  In terms of the direction of this Commission, the DGHS constituted a Board of four Medical Experts viz:

             (i)   Dr. O.P. Pathania, Professor, Department of Surgery,

                   LHMC & Smt. S.K. Hospital, New Delhi – 110 001;

(ii)  Dr. Manju Sharma, Member, Consultant, RML Hospital, New Delhi;

(iii)   Dr. Archana Aggarwal, Consultant, Department of         Radiodiagnosis, VMMC & Safdarjung Hospital, New Delhi;

(iv) Dr. Gulshan Jit Singh, Consultant & Head, Department of    Surgery, VMMC & Safdarjung Hospital, New Delhi.

             The Board constituted by the DGHS after going through the entire record of the medical treatment and gave their opinion as under:

“Summary:

Mrs. Talat Choudhary, 52 years Female was admitted on 25.3.1997 vide CR No. 495592 in Surgical Unit III AIIMS, New Delhi.  She was operated on 27.3.1997.  laparoscopic cholecystectomy was started which was converted to open cholecystectomy on detecting CBD injury (due to unclear anatomy) and Roux en Y Hepaticojejunostomy was done.  Post-operative stay was uneventful.  Tc 99m scan done on 03.4.1997 at AIIMS showed patent Hepaticojejunostomy (page 3 of the document provided shows the date as 03.4.1997, page 19 shows the date as 03.3.1997 and page 16 does not mention any date on the test report provided).  Patient was discharged on 4.4.1997.

Patient had persistently raised Serum Alk. Phosphatase but Ultrasound abdomen & CT abdomen done at Patna on 10.6.1997 was not showing any evidence of biliary stasis.

Patient was investigated at SGPGI, Lucknow, HIDA scan done on 04.7.1997 revealed evidence of stenosed biliary enteric anastomosis (page 12 shows the report however there is some overwriting in the report marked X, may be checked with the original for confirmation) for which Redo Surgery was done on 05.7.1997.  Patient was discharged on 23.7.1997.  Post-operative HIDA scan was done on 18.8.1997 showed patent anastomosis.

Observations:

Laparoscopic Cholecystectomy for Gall stone disease is a preferred mode of treatment.  CBD injury is a known complication of Laparoscopic as well as open Cholecystectomy.  Conversion to open Cholecystectomy upon suspicion/detection of CBD injury is a standard procedure as and when indicated.

On perusal of operative records of AIIMS, injury to the CBD in this patient was recognized intraoperatively and approximately laparoscopic procedure was converted to open procedure and remedial corrective measure in the form of Roux en Y Hepaticojejunostomy was performed which is a standard operative procedure for such complication.  Tc 99 m scan done on 03.04.1997 at AIIMS showed patent anastomosis. 

Conclusion:

Committee is of the opinion that Laparoscopic Cholecystectomy was converted to open cholecystectomy and appropriate corrective measures (Hepaticojejunostomy) for the CBD injury were successfully taken.  At no stage any evidence of negligence is forthcoming on the perusal of relevant medical records made available to the committee.”

9.      To elicit the detailed information and other clarifications, a set of as many as 34 interrogatories was served on the opposite parties with the leave of the Commission and the same have been duly replied by the opposite parties.  Some of the interrogatories and their replies are germane to decide whether there was any lack of care on the part of the operating surgeon and his team.  For the facility of reference we would extract the relevant interrogatories and their replies:

“1.        Interrogatory No.4 – When did you first perform an operation by Laparoscopy technique?  How many surgery cases exclusively by Laparoscopic method were carried out by you personally before this case?  And is there any record of it?

            Reply:  Laparoscopic Cholecystectomy was introduced in late 1980s and was soon adopted at AIIMS.  The exact number of surgery exclusively by laparoscopic method, by OP No.2 before the case in question is difficult to ascertain for want of specific records.

2.         Interrogatory No.5 - How much total time was actually consumed in the surgery of complainant on 27.3.1997.  And is there any record of it?

            Reply:  Even though it is difficult to say anything with certainty at this time.  However, on the basis of documents on record it appears that the surgery in question was started at 9.15 A.M. and came to an end at 12.15 P.M.  This is on the basis of conterminous records.  The copy of the Anesthetists in the OT records is attached as Annexure OP-1.

3.         Interrogatory No.8 -  In how many cases before this case, while performing laparoscopic cholecystectomy, common bile duct injury was caused by you.

            Reply:    Prior to the case at hand no bile duct injury was reported by any one in amongst the surgeries performed by the OP No.2.

4.         Interrogatory No.9 -  Do you agree that in the discharge summary or at least in the operation note a mention is supposed to be made of abnormality if any found in anatomy of any patient?

            Reply:    Yes, the discharge summary of the present complainant does mention abnormality found in the anatomy of the patient.

5.         Interrogatory No. 10 -   Whether you agree “That positive identification of anatomy before any structure is legated, divided or dissected is must and mandatory in Laparoscopic Cholecystectomy?

            Reply:     During any surgery either open or laparoscopic, structures are identified before being legated and divided.

6.         Interrogatory No.11 -   Will it amount to negligence and carelessness if injury to bile duct is caused during process of hole making itself?

            Reply:    That injury to bile duct during process of hole making itself, is not in itself negligence and/or carelessness.

7.         Interrogatory No. 12 -  What do you have to say that on observing any complication a careful surgeon is supposed to convert to conventional method and not persist with Laparoscopic method?

            Reply:     That immediately on observing any complication any surgeon is supposed to convert the procedure to conventional method.  As soon as bile leak was noted in the present patient, the procedure was converted to an open procedure.

8.         Interrogatory No. 14 -   Which of the following reasons given on your behalf you think is the actual reason for the causing of bile duct injury?

            (i)         Unclear ductal anatomy as referred in ‘discharge summary’

            (ii)        Undue brittleness of tissues referred in para 19 of written reply

            (iii)       Chronic Cholecysitis of patient ‘referred in para 2 of affidavit.

           (iv)        Anatomy of cystic duct not clearly identifiable ‘referred in para 2 of the affidavit’

               (v)     Chronic Cholecystitis reaction is higher and more severe due to which identification of anatomy becomes difficult ‘referred in para 6 of affidavit’

               (vi)    Inflammation (referred in para 6 of affidavit)

            Reply:     The factors raised in interrogatory 14 (from i to vi) are known factors of bile duct injury.  At times more than one factor are present in a given cases.  The contributory or independent value of each is difficult to ascertain.

9.         Interrogatory No.16 -   Is oozing of bile not a clear indication that bile duct injury had already been caused?  What do you have to say?

            Reply:     The answer depends on the quantity of oozing of bile and there cannot be strict formula for that.  However, as soon as bile like was detected the laparoscopic procedure was converted to an open conventional method.

10.      Interrogatory No.17. -   Whether you had properly and positively identified the anatomy before cutting in this case.  It is correct to say that if there is no positive identification of anatomy as in the present case it would not have been advisable to go for Laparoscopic Cholecystectomy.

            Reply:    During laparoscopic manoeuvre nothing was cut.  However, dissection was attempted to clarify the anatomy.  It is at this stage bile like was detected.

11.      Interrogatory No.19 -   At what stage of surgery the Bile Duct injury was caused – during hole cutting, or after dissection started, what do you have to say?

            Reply:    During laparoscopic manoeuvre nothing was cut.  However, dissection was attempted to clarify the anatomy.  It is at this stage bile like was detected.

12.      Interrogatory No.20 -  What steps had you taken to identify hepatic, cystic and bile ducts?  Were hepatic and bile ducts identifiable?

            Reply:    That during open surgery all these ducts were identified.

13.      Interrogatory No.24  -  Please refer to para 7 of affidavit that decision to convert is taken by surgeon on operation table.  Whether in totality of circumstances and situation the decision to convert to conventional method was taken too late.

            Reply:    As soon as bile leak was noted a decision to convert was taken without wasting any time.  There is no question of the decision to convert being late.

14.      Interrogatory No. 30.  -  If as mentioned in paras 13, 15 and 17 of your written reply shrinkage of the passage in bile duct created by you was on account of peculiar healing characteristics of the patient.  Can you explain why such shrinkage did not occur after surgical correction of bile passage at SGPGIMS Lucknow in the operation subsequently performed?

            Reply:    The fact that the surgeon at SGPGIMS noted raised alkaline phosphates is suggestive and indicative of shrinkage of the passage.  This fact confirms and justify the reasoning of the OP given in the written reply.

15.      Interrogatory No. 31 -    In para 10 of written reply it is stated that “as soon” as possibility of the bile duct injury was realized OP No. 2 immediately converted to open procedure.”  Do you mean to say that conversion as done before the bile duct injury was caused?

            Reply:    The reference of para 10 of written reply is misreading thereof.  The contents of para 10 of the written reply is reiterated.  The decision to convert the procedure was as a sequel to the bile leak, which could have been for different reasons and not necessarily for bile duct injury.

16.      Interrogatory No. 32 – In para 13 of the written reply you have tried to absolve yourself of responsibility by putting blame on healing characteristics of the complainant, what do you have to say that after surgical correction done at SGPGIMS, Lucknow, after the operation done by you, the suffering of the complainant described in para 12 to 15 of complaint ended up to great extent, and no further surgical correction as required with the same healing characteristics.

Reply:   The interrogatory under response has already been replied as above.  The fact that the surgeon at SGPGIMS noted raised alkaline phosphates is suggestive and indicative of shrinkage of the passage.  This fact confirms and justify the reasoning of the OP given in the written reply.

17.      Interrogatory No. 33 -  Is it true that in surgery negligently done through Laparoscopic technique by you, first the bile duct of the complainant was injured and then the repair done by you in surgery through conventional method was also negligently done and was not successful.  Complainant had to undergo lot of sufferings and necessitated a second surgery within 3 ½ months of your surgery to save her life.

Reply:   It is absolutely incorrect that either the surgery was done negligently or the repair thereof was deficient in any manner.  The findings after the surgery at SGPGIMS confirms and justify the reasoning of the OP given in the written reply.”

10.    Complainant No.2, then submitted that the reply to the interrogatories would show that due care was not exercised by the operating surgeon to visualize the anatomy of the complainant No. 1 before embarking upon the procedure of laparoscopic cholecystectomy.  Indeed his submission is that the non-visualization of the duct anatomy was the main cause which led to the CBD injury.  In support of his submissions he heavily relied upon the opinions contained in certain medical text i.e. Laparoscopic Surgery of the Abdomen by Bruce V. MacFadyen, Jr., MD & Others (published by Springer), wherein the Authors of the said book have said so in regard to the General Principles, Adequate Exposure, Dissection and Maintenance of Hemostasis, Identification of the Anatomy etc., by observing as under:

General Principles:

………..

4.           Positive identification of the anatomy before any structure is ligated or divided.

Adequate Exposure:

…..The surgical dictum that you can only operate on what you can see remains a guiding principle of laparoscopic surgery…..

Dissection and Maintenance of Hemostasis

….. Laparoscopy is a visual procedure and what you cannot see you cannot safely dissect….

Identification of the Anatomy

….. Absolute identification of the anatomy of the portahepatis and triangle of Calot before ligation of any structure is the only safe way to reduce the risk of inadvertent injury, particularly to the common bile duct…..

11.    At this stage it will be useful to note the circumstances in which, the incidence of CBD injury are indicated by other Authors of the Medical Text books.  In the book Sleisenger and Fordtran’s Gastrointestinal and Liver Disease Edited by Mark Feldman, Lawrence S. Friedman and Marvin H. Sleisenger, 7^th Edition – Section titled under the heading “Complications Following Laparoscopic cholecystectomy” it has been laid down:

      “Laparoscopic cholecystectomy has laregely replaced “open” surgical cholecystectomy because laparoscopic cholecystectomy results in shorter hospital stay, faster recovery and lower overall morbidity rate.  Unfortunately, the frequency of complications resulting from the bile duct injury has increased with the advent of laparoscopic cholecystectomy.  Bile Duct injury, which was observed in 0.1% of open cases, may occur inas many as 0.2% to 0.5% of laparoscopic cases.  In addition, laparoscopic bile duct injuries tend to be more severe and more difficult to treat than biliary injuries produced by open surgery.

       Bile duct injury that occurs during laparoscopic cholecystectomy results in two basic problems L1) bile leak with biloma formation and (2) biliary obstruction caused by stricture formation.  Patients may present with pain and fever from a biloma of jaundice because of biliary obstruction.   Bile leaks result from incomplete clipping of the cystic duct or laceration or transection of central or peripheral bile ducts.  Failure to recognize variant bile duct anatomy, particularly an aberrant low insertion of a segmental right duct, is a common cause of bile duct transection.  Strictures tend to occur in the common hepatic duct owing to thermal injury to the hilum from cautery and dissection probes.  Strictures or obstruction can also result from inadvertent ligation of aberrant ducts.

       The initial work-up of patients with presumed bile duct injury includes cholangiography to assess the biliary anatomy and a cross-sectional imaging study such as CT or US to investiage the presence and location of biloma.  Cholangiography is performed via an endoscopic approach when possible.  Billiary tract disruption results in decompression of the bile duct and the ducts may actually be decreased in calibure, making percutaneous cannulation difficult or even hazardous.  When endoscopic cannulation of the duct is not  possible or when contrast material cannot be directed into the intrahepatic ducts, PTC may be necessary.  In patients with possible laparoscopic cholecystectomy injury, it is particularly important to opacify all the intrahepatic ducts by cholangiography.  Inadvertent ligation or peripheral ducts may result in incomplete opacification of the biliary tree, which is difficult to notice immediately.

       The treatment of bile duct injury following laparoscopic cholecystectomy depends on the nature and extent of injury.  Small to moderate bile duct leaks at the cystic duct stump or peripheral ducts may be cured with non-operative therapy alone, but large leaks or transection of the main  ducts often requires surgery.  The treatment of small bile duct leaks includes percutaneous drainage of large or symptomatic bilomas coupled with a biliary drainage procedure to divert bile from the site of injury.  The drainage catheter is initially placed into the biloma under US or CT guidance and then the collection is evacuated.  External biloma drainage is continued until biliary output through the drain ceases.  Billiary diversion is usually achieved endoscopically by sphincterotomy and placement of a temporary plastic endoprosthesis.  Although the leak may require several stent changes to achieve complete closure, most leaks will close within six weeks.

        Strictures after laparoscopic cholecystectomy may occur after an uneventful operation and may not be recognized until many months to several years after surgery.  The treatmentof these strictures is usually surgical – creation of a Roux-en Y hepaticojejunostomy.  In slected patients who cannot undergo this surgery because of severe medical problems or cirrhosis with portal hypertension, non-operative management by means of balloon dilation and placement of a metallic endoprosthesis may be appropriate.  Lillemore and colleagues reported a success rate of 100% in the treatment of the bile duct strictures using a combination of surgery and percutaneous dilation.  However, the cost of treating these patients was quite high, with mean cost of $51,000/-.”

12.    What amounts to medical negligence on the part of a medical professional has been considered by the Hon’ble Supreme Court and Foreign Courts in number of its decisions.  In this connection reference may be made to the celebrated and oftenly cited Queen’s Bench Division in Bolam V Frirn Hospital Management Committee Hospital Management Committee (1957) 1 WLR 582, (Queen’s Bench Division), Spring Meadows Hospital & Another V. Harjol Ahluwalia & Anr. (1998) 4 SCC 39 / Indian Medical Association Vs. V.P. Shantha & Ors. (1995) 6 SCC 651, Dr. Laxman Balkrishna Joshi V. Dr. Trimbak Bapu Godbole and Another, AIR 1969 SC 128 / Savita Garg (Smt.) Vs. Director, National Heart Institute (2004) 8 SCC 56 / Malay Kumar Ganguly Vs. Sukumar Mukherjee Doctors & Ors. 2009 CPJ 17 (SC) / Martin F D’Souza Vs. Ishfaq – I (2009) CPJ 32 (SC)

13.    We do not wish to burden this opinion by referring to all those decisions in detail.  Certainly we would like to take into account the legal position which emerges from the said decisions.  The Hon’ble Supreme Court on consideration of the above referred Foreign and Indian decisions in the case of Kusum Sharma & Others Vs. Batra Hospital (2010 CPJ) culled out the following principles:

“Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.

ii. Negligence is an essential ingredient of the offence. The negligence to be established by the prosecution must be culpable or gross and not the negligence merely based upon an error of judgment.

iii. The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires.

iv. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.

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.

viii. It would not be conducive to the efficiency of the medical profession if no Doctor could administer medicine without a halter round his neck.

ix. It is our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessary harassed or humiliated so that they can perform their professional duties without fear and apprehension.

x. The medical practitioners at times also have to be saved from such a class of complainants who use criminal process as a tool for pressurizing the medical professionals/hospitals particularly private hospitals or clinics for extracting uncalled for compensation. Such malicious proceedings deserve to be discarded against the medical practitioners.

xi. The medical professionals are entitled to get protection so long as they perform their duties with reasonable skill and competence and in the interest of the patients. The interest and welfare of the patients have to be paramount for the medical professionals”.

14.    On a consideration of the above noted authoritative opinions of the Medical experts and bearing in mind the legal position, there cannot be any denial of the position that the CBD injury is a well-known complication of the laparoscopic cholecystectomy procedure and frequency of such complications has increased with the advent of laparoscopic cholecystectomy.  It is much higher, say almost double or four times than in the case of open / conventional cholecystectomy.  Therefore it must be presumed that the incidence of CBD injury is a well-known risk when a patient undergoes a laparoscopic cholecystectomy procedure.  In other words, the same cannot be correlated as the act of negligence or carelessness on the part of the operating surgeon.  In  a case where a patient has incidentally suffered  CBD injury during the laparoscopic procedure cannot by itself be presumed to be a result of negligence in all such cases. However, that does not mean that a surgeon conducting the laparoscopic cholecystectomy procedure would be immune even if the CBD injury has been caused due to his negligence / lack of care in performing the said procedure.  In the case in hand, the complainants  are mostly harping upon the situation that the anatomy of the complainant No.1 was not fully and properly visualized before she was booked for laparoscopic cholecystectomy procedure for the removal of the stone from the gallbladder.  In other words, the complainant wants to suggest that the operating surgeon has overlooked the said situation.  This argument does not cut much ice because in the present case, the complainants have failed to show that complainant No.1had any abnormal / unusual anatomy on the face of which procedure of laparoscopic cholecystectomy was counter indicative or the operative surgeon should have gone only for conventional / open cholecystectomy procedure even to begin with.  From a perusal of the Notes of Surgery, it does not appear that the operating surgeon encountered with such a situation.  Rather it would show that the surgeon had to convert the procedure of laparoscopic cholecystectomy into open cholecystectomy, when it was noticed that there was oozing of the bile.  Merely because the laparoscopic cholecystectomy had to be converted to open cholecystectomy procedure, it cannot be said that the laparoscopic cholecystectomy procedure adopted by the surgeon was counter indicative in the case of the complainant No.1.  We therefore hold that no negligence can be attributable to the opposite parties on that count.

15.    As regards, the procedure of laparoscopic cholecystectomy and the procedure adopted to correct the CBD injury, no fault can be found with the same as has been opined by the body of medical experts (supra).   Once it is shown that due medical protocol was followed, no case of medical negligence is made out against the opposite parties.

16.    As regards the subsequent and persisting problems, which complainant No.1 claims to have suffered even after her discharge from the opposite party No.1-Hospital, suffice it to say that such post-operative problems after such a complication were normal and had subsided after the complainant No.1 took treatment at certain other medical centers.  In any case, the complainant No.1 was discharged from the hospital on 04.4.1997, in a satisfactory condition and she did not revert back to the said hospital for consultation about the subsequent problems, which she had to face, may be for the reason that the complainants had lost faith in the treatment given by the opposite parties.  On that count also, it is also not possible to fix any liability on the opposite parties.

17.    Thus on a consideration of the entirety of the facts and circumstances of the present case, the evidence and material brought on record, the opinion of expert body and the view of the well-known Authors in different medical text books, the irresistible conclusion is that the complainants have failed to establish their case about the medical negligence and / or deficiency in service against the opposite parties in the treatment of complainant No.1.  The complaint being devoid of any merits is accordingly dismissed, leaving the parties to bear their own costs.