1.       The present complaint has been instituted by the parents and the elder sister of the deceased, Manasi Tilak, who have complained of negligence in  management, diagnosis and treatment of the deceased at the OP-1 Hospital under the OP-2 to 4.  The allegations are that the OPs-1 to 4, particularly, the OP-2 Dr. Dharma Choudhary did not take prompt care to analyse and diagnose the requisite treatment with the right dosage of medicine at the appropriate time, as a result whereof  the deceased developed Graft versus Host Disease (GvHD). The contention is that had the deceased been administered the correct medicine and the right dose at the appropriate time, the sufferance of the disease would not have advanced from Grade-I/II to Grade –IV which happened at the Hospital of OP-1 where the treatment was being given by the OP-2 and his team of doctors. 

2.       The case has a chequered history as there are events that have occurred during the pendency of the complaint as an outcome of the orders passed from time to time and which need to be chronologically referred to.

3.       At the outset, it may be pointed out that the deceased child was diagnosed for Acute Lymphoblastic Leukemia (ALL) Pre-V on 16.01.2010 at Sir Ganga Ram Hospital, New Delhi.  At that time, she was an eight year old girl and upon diagnosis, she was put on chemotherapy and other tests including Bone Marrow Test was awaited.  The said treatment plan of Sir Ganga Ram Hospital is on record, which also indicates that she was also advised and administered Prednisolone 40 mg daily for 28 days and then to be halved every three days to taper over 9 days.  She was discharged from Sir Ganga Ram Hospital on 19.01.2010, where-after her Leukemia re-lapsed and she was admitted at Indra Prastha Apollo Hospital, New Delhi in 2012.  She was discharged on 18.08.2012 after 5 days in the hospital after undertaking chemotherapy and was discharged in a stable condition.  She was advised to be re-admitted on 27.08.2012 and then again admitted on 28.08.2012 and discharged on 12.09.2012. During this period her chemotherapy continued. She was again admitted for chemotherapy at Appollo Hospital and was there from 20.09.2012 to 05.10.2012. 

4.       Thereafter, she was planned to visit the Christian Medical College, Vellore for Bone Marrow Transplant (BMT).  She was admitted on 20.11.2012 at Christian Medical College, Vellore, where her Bone Marrow Transplant was carried out on 29.11.2012 and was discharged on 24.12.2012.  The discharge summary of the hospital advised for local follow up with Dr. Dharma Choudhary in B.L. Kapur Hospital- OP-1 & 2 herein.

5.       She arrived and met the OP-2, who clinically investigated her on 09.02.2013 and advised her the medicines and also advised investigations as well. She was called on after 10 days to visit again on 20.02.2013.  On 20.02.2013, tests were carried out and further pathological tests were advised. The prescription dated 20.02.2012, does prescribe Necrol-25 mg (a Cyclosporin drug) B.D. Her pathological tests are on record dated 20.02.2013 relating to her blood data, Kidney Function, Liver Function etc. 

6.       The complainants have come forwarded contending that on 05.03.2013, Cyclosporine, which had been prescribed, to have to be administered in a tapering way by the Christina Medical College, Vellore,  was stopped by the OP-2.  This according to the complainants was done without carrying out any tests or examining the requirement of the patient but the OP-2 casually asked the complainants to come after 10 days after stopping Cyclosporine.  According to the complainants neither any monitoring or suggestions or any tests were carried out by the OP-2, which was not a prudent act on his part, which resulted in the complications in the GvHD getting aggravated, which had already set-in. 

7.       On the patient experiencing rashes behind her ears and passing of loose stools, on 14.03.2013 visited the OP-2, who advised the blood tests and noted the rashes as complained of. He also noted the soft stool that was reported and a test was carried out.  The very next day, the patient was examined on 15.03.2013 and the stool frequency was noted with a diagnosis of Skin GvHD less than 25%.  Tab. Necrol, which had been prescribed on 20.02.2013, was again advised on 15.03.2013 with a 50 mg dose twice  daily.  It is not disputed between the parties that Necrol is the brand name of Cyclosporin. The Complainants allege deficiency and negligence against the OP No. 2 for not having advised administration of Cyclosporin from 06.03.2013 to 15.03.2013.  They urge that since immunosuppressant was not administered during this period, it gave rise to GvHD that gradually increased.

8.       In view of her conditions, she was advised admission and accordingly admitted the next day on 16.03.2013 at the OP-1 Hospital, where she was treated and discharged on 27.03.2013.  This discharge was made on request for visiting the primary Transplant Centre for further management namely, Christian Medical College, Vellore. 

9.       The discharge summary of the hospital is on record.

10.     The patient arrived at Vellore on 27.03.2013, where she was treated. But unfortunately she passed away on 12.04.2013 and the death summary of the Christian Medical College, Vellore is also on record.

11.     The present complaint was instituted, arraying the Opposite Parties, including the Christian Medical College, Vellore as OP-5, on 20.11.2013.  Notices were issued on 02.12.2013 and on 20.03.2014, time was granted for filing the written versions and evidence.  A statement was made on behalf of the OP-5 that since no relief had been claimed against them, therefore, they do not propose to file any written statement.    This was in conformity with the prayer made in the complaint, where all reliefs are claimed only against OP-1 to 4, yet, the Bench directed the OP-5 to file the entire medical record  of the deceased before the Commission.

12.     The case proceeded with the filing of Affidavits and exchange of pleadings, where-after the documents were exhibited and marked by the parties and on 21.07.2017, it was recorded that the reply of OP-5 was taken on record subject to objections and further IA/2159/2017 was entertained that was moved on behalf of the complainants for obtaining an expert evidence.

13.     Learned Counsel for the Opposite Party however, made a request that only those documents be sent along with a terms of reference to be perused by the committee of experts.  The Court directed the filing of the terms of reference on which consensus of the learned Counsel was sought by the order dated 25.08.2017.  Since, there was a controversy in respect of the terms of reference offered by them, the Bench requested Mr. Joy Basu, Learned Sr. Counsel to sort out and present the terms of reference in order to enable the expert committee to proceed further.

14.     The terms of reference were submitted.  A copy whereof is also on record along with a summary of the submissions made by the respective parties and then the reference was framed to be placed before the Expert Committee.

15.     Accordingly, the said terms of reference was sent to the Director, All India Institute of Medical Sciences (AIIMS) to nominate three experts in the field to give opinion on the subject matter vide order dated 08.12.2017.  The report dated 08.02.2018 was noticed and taken on record on 16.02.2018, to which an objection was filed on behalf of the complainants. 

16.     The written statement of the OPs-1 to 4, along with documents, was served on the learned Counsel for the OP-5, who took some objections to the response of the OPs-1 to 4 and on that short ground filed an Affidavit dated 17.05.2017, which is also on record.

17.     The case proceeded, but it seems could not be taken up for final hearing and ultimately on 05.12.2023, the following order was passed:- 

“An adjournment is being sought. But before the matter is adjourned, it would be suffice to mention that this is a complaint of the year 2013 regarding medical negligence.

From the record it appears that when the matter proceeded, the Commission on 21.07.2017, while dealing with IA/2159/2017, recorded the following order:

“Learned Counsel for Opposite Parties No.1 to 4 states that the said Opposite Parties have no objection if opinion of a Committee of Experts is obtained. She, however, submits that in order to avoid prejudice to any of the parties to the Complaint, only the documents filed by the parties, along with the terms of reference may be referred to the said Committee. In view of the submission, we direct Counsel for the contesting Parties to file draft terms of reference, which could be made to the Committee of Experts. The said terms shall be filed within two weeks.

List the Application for further orders, on 25.08.2017.”

     In terms of the said order, Mr. Joy Basu, learned senior counsel was appointed as amicus curiae to draw the terms of reference for being referred for an expert opinion to the All India Institute of Medical Sciences. Regarding the said proceedings, on 27.10.2017, the Commission recorded the following order:-

“Since there is some controversy with regard to terms of reference to be made to a Committee of medical experts, we have requested Mr.Joy Basu, Learned senior Counsel, who is present in connection with some other cases, to assist us in framing the terms of reference.  For the present, the Complainants and the Opposite Parties No.1 to 4 shall deliver the terms of reference, which they have already filed for our consideration, in the chamber of Mr. Basu within a week from today.

 It will be open to the learned senior Counsel to seek assistance and further information as may be required for the afore-said parties from the Counsel for the parties.

 List for directions on 08.12.2017.”

    The terms of reference upon being drawn up were agreed to by the counsel for the parties for being referred to an independent committee of experts. This reference was accepted and is recorded in the order dated 08.12.2017, extracted herein under:

“Pursuant to our request, contained in the order dated 27.10.2017, Mr. Joy Basu, learned Senior Counsel has drafted the terms of reference along with the brief summary of the facts and the issues arising for adjudication in the Complaint.  The same have been supplied to learned Counsel for the parties

Learned Counsel for the parties are agreed that the terms of reference, so drawn, may be referred to an independent Committee of Experts.

In view of the above, we request the Director, All India Institute of Medical Sciences, New Delhi (AIIMS) to nominate three experts in the field, competent to give opinion on the subject matter of the Complaint, summarized in the terms of reference itself.  It will be open to the Committee of experts to seek any clarification, as may be considered

necessary, for the opinion, from either of the parties.  It is, however, clarified that the said information/clarification shall be sought by the Committee in the presence of both the parties.  We request the Committee to give its opinion within four weeks, from the date of its constitution, to the Director, who in turn will forward the same to this Commission.

Office is directed to send the terms of reference, as drafted by the learned Amicus Curiae along with the medical record of the case to the Director, AIIMS forthwith.

Before parting, we place on record our deep appreciation for the assistance rendered by the learned Amicus Curiae in drafting the terms of reference.

List for directions on 16.02.2018, for awaiting the report.”

     Upon receipt of the said report on 12.01.2018, the Commission directed that a copy of the report delivered to the learned counsel for the parties, whereafter on 14.05.2018, learned counsel for the complainant requested that she may be granted time to file objections to the report received from the experts.

     An interim application being IA/9109/2018 was moved on 04.05.2018, raising objections against the opinion of the experts which is on record.

     It appears that all applications were directed to be considered at the time of final disposal of the complaint vide order dated 01.08.2018 but there is no specific mention of IA/9109/2018.

    The matter proceeded and on 30.01.2020, the Bench of this Commission opined that the objections raised to the expert committee report could only be considered if there is some other expert report to be filed by the complainant. Pursuant to this order, the complainant’s counsel moved IA/2991/2020, seeking further time to file another expert opinion but till date no such opinion has been filed or brought on record.

    It is in this background that adjournment has been sought. As noted above, since the matter is of the year 2013, the same deserves to be disposed off at the earliest.

    As agreed by learned counsel for the parties list on 06.02.2024.”

18.       It may be noticed that an application IA/2991/2020  had been filed by the complainants for procuring and filing another counter expert opinion, but the same could not be filed. 

19.       This fact was noticed once again on 06.02.2024, but the learned Counsel for the Complainants made a statement that since she has not been able to procure any expert opinion, therefore, IA/2991/2020 was accordingly disposed of, without prejudice to the rights of the complainants to advance their submission on the basis of the documents already on record.  The order dated 06.02.2024 is extracted herein as under:-

“The Complainants moved an objection to the expert report vide an IA/9101/2018 filed on 04.05.2018 which has been incorrectly recorded as IA/9109/2018 in the order dated 05.12.2023. This application seeks to question the expert opinion on several grounds that have been detailed in the said application. These grounds of objection therefore are in the nature of submissions questioning the report which obviously can be taken into consideration at the time of final hearing of the matter. Hence this application stands disposed off with liberty to the Complainants to raise these issues by way of submissions at the time of final hearing.

     However, the Complainants have moved another application being IA/2991/2020 praying for extension of time to file another counter expert opinion in compliance of the order dated 30.01.2020 that was allowed. Learned Counsel for the Complainants states that in spite of best efforts the Complainants could not muster any such opinion and therefore the matter may proceed on the merits of the claim without awaiting for any further expert opinion. Accordingly, the disposal of IA/2991/2020 shall not prejudice the rights of the Complainants to advance submissions on the existing material as indicated herein above.

          List on 08.04.2024.” 

20.     The case was again taken up on 08.04.2024 and upon hearing the arguments, learned Counsel for the complainant was permitted to present her short synopsis and notice to facilitate the response from the OPs and to proceed further with the matter.  This is how the matter was taken up for final hearing on 03.08.2024 and learned Counsel for all the parties have been heard. 

21.     The contention advanced on behalf of the Complainants is that Opposite Party No.1 to 4 did not properly attend to the patient and the Opposite Party No.2 was casual about his approach towards the diagnosis and treatment of the patient which was neither prompt nor in accordance with the protocol, as expected of a doctor of his reputation and skill and consequently, this casual approach, which was imprudent in the case of a high risk patient, resulted in deterioration of the patient’s condition who ultimately passed away on account of improper management of GvHD for which she was diagnosed.  It is urged that on the said diagnosis, the Opposite Party No.2 neither adopted the first line of treatment or the second line or the third line of treatment.  It is also alleged that he did not give any advice nor did he follow up the protocol nor did he administer the proper dosage of medicines which amounted to giving no treatment for GvHD.  Consequently, the death of the patient that happened in Vellore could have been avoided and the medical records placed along with the complaint establish the same.

22.     The objections have been taken to the medical report of All India Institute of Medical Sciences dated 08.02.2018 contending that the incorrect factual interferences are apparent in the report and therefore, the same being inconsistent, no reliance can be placed on the same.  It is urged that it is for this reason that IA No.9101 of 2018 was moved by the Complainants raising objections to the correctness of the said medical expert report.

23.     Advancing her submissions, it is urged that as advised by CMC Vellore it was incumbent upon the Opposite Party No.2 to have reviewed the continuance or otherwise of the administration of Cyclosporine which was abruptly stopped on 05.03.2013.  It is urged that no test was carried out to assess the continuance or otherwise of the said medicine by the Opposite Party No.2 which was essential as it was an immuno suppressive drug that was required to be administered to prevent any accommodating or adjustment complications arising of the Bone Marrow Transplant. The submission is that the stoppage of the said medicine became critical as its stoppage aggravated the complications as a result whereof GvHD set in.  It is further submitted that the patient was called after 10 days for future advice after visit on 20.02.2013.

24.     It is urged that when the patient visited on 14.03.2013, she reported symptoms of rashes and loose stool that was noted by the Opposite Party No.2, yet according to the Complainants, no steps were taken by him to counter and treat the patient for GvHD.  On the next day, i.e. 15.03.2013,  the Opposite Party No.2 himself recorded “skin GvHD” and according to the learned Counsel, the grade and stage of the said symptom was already advanced which was not treated by carrying out any test or biopsy which was needed at that stage.  The contention is that had these tests been carried out on the very first day, the line of treatment and dosage of medicine could have been appropriately administered to the patient as was needed in terms of the protocol.  The contention is that neither the first line nor the second line was adopted inspite of the fact that the patient was admitted in the hospital on 16.03.2013.

25.     The contention is that inspite of having entered into the hospital still no tests were carried out and the condition of the patient went on worsening.  According to the Complainants, the Opposite Parties were inattentive and when the situation worsened then it was on 21.03.2013 for the first time that the tests were carried out and Cyclosporine was restarted.  It is also urged that there was neither any nutrition diet being administered to the patient nor any care as required for maintaining her health conditions was observed, and this absence of due care was a clear negligence on the part of the hospital and the Opposite Party No.2.  It is submitted that on her admission no care was taken for 4/5 days, as urged hereinabove, nor any tests were carried out and it was for the first time on 21.03.2013 that the Opposite Parties proceeded to undertake the tests by which time the treatment had been delayed considerably that resulted in the worsening of the health condition of the patient.

26.     The persistence of loose stools and rashes, according to the Complainants, were sufficient for the Opposite Parties to have undertaken a more aggressive treatment as needed above and reliance has been placed on the British Journal of Hematology of July 2012 to substantiate these submissions.  Learned Counsel urged that the belated and incorrect methodology adopted by the Opposite Party No.2, which was against the standards explained in the medical texts, no treatment was given on the first two crucial days in spite of the diagnosis of GvHD.  The dosage of prednisolone 20 mg and other medicines along with Cyclosporine were not the correct dosage which the learned Counsel submitted not to be matching with recitals contained in the guidelines of the Journal referred to hereinabove. 

27.     The negligence, therefore, in not administering the correct treatment at the right time resulted in uncontrolled GvHD, which was mild at the time of admission and this happened because the Opposite Party No.2 failed to start the immuno suppressive drug at the theropeautic dose on the first day itself.  The patient suffered for several days together and this negligence without any supportive treatment of gut rest and supportive nutrition resulted in the poor condition of her health.  Even intravenous steroids were not administered and therefore, there was a failure in reassessing and review of the status of the patient.

28.     A comment has also been made by the Complainants that the dosage of 2 mg per kg body weight was not administered to the patient which again was not in accordance with the medical literature on which reliance has been placed.

29.     It is in these conditions that the patient had to be got discharged and was taken to Vellore where she ultimately died.

30.     The Complainants have, therefore, enlisted medical negligence on day to day basis in the Complaint till 27.03.2013 to contend that the said negligence has been established and therefore, the Complaint deserves to be allowed.

31.     Learned Counsel for the Opposite Parties No.1 to 4 have countered the aforesaid averments urging that the factual contentions are incorrect and after the expert report of the All India Institute of Medical Sciences, constituted of a body of the experts in the field of oncology, having opined that there was no medical negligence established, the entire arguments advanced on behalf of the Complainants cannot be countenanced.

32.     He has further submitted that the Opposite Party No.2 had very diligently and appropriately dealt with the patient by timely and promptly attending to her and diagnosing the correct treatment that was valid as per medical protocol.  He submits that the past ailment of the child who was unfortunately suffering from the disease also indicated the existence of such symptoms from before.  He has urged that an “acute skin GvHD” (Glucksberg Grade-I) was also diagnosed before as is evident from the discharge summary dated 24.12.2012 of Vellore hospital that is on record.  The contention, therefore, is that she had no other symptom as the report under Section III had categorically recorded the problem regarding this disease with a clear finding that she had no features of “gut or liver GvHD”.   The very diagnosis of acute skin GvHD, therefore was sought to be controlled by the administration of Cyclosporine in measured doses which was clearly prescribed by the Vellore Hospital at item no.VII in the discharge summary.

33.     It is, therefore, submitted that this was not a development at the hospital of the Opposite Party No.1 but was existing from before and the medicine prescribed was being administered as per the dosage indicated therein.

34.     Learned Counsel urged that the said discharge summary while referring the case to the Opposite Party No.2 at the Opposite Party No.1 hospital had also indicated that Cyclosporine had to be administered in a tapered way and after administration of 75mg in the 1^st week, it was to be gradually reduced to 25 mg once daily in the last week and had to conclude finally with the stoppage of the medicine.  Learned Counsel emphasized on the word ‘stop’ used in the discharge summary to contend that the medicine was stopped on the advice of the Vellore hospital and not by the Opposite Party No.2.

35.     He further submits that to the contrary, the said medicine continued till 05.03.2013 and before that in between the patient had come to the Opposite Party No.2 on 09.02.2013 and again on 20.02.2013 when the medicines were continued as per the advice from the Vellore.  However, simultaneously tests were carried out on 20.02.2013  to assess the continuance or otherwise of the medicines and accordingly Cyclosporine was continued as no reason was found to discontinue the same as advised at Vellore.  The contention, therefore, is that while examining the patient there was no advice from the Opposite Party No.2 to stop the medicine of Cyclosporine as advised at Vellore.  The Opposite Party No.2 had not stopped the medicine.  It was discontinued as per the advice of the Vellore Hospital.

36.     It is urged that the contention of the Complainants that the Opposite Party No.2 ought to have reviewed the same is without any basis inasmuch as no such condition was reported by the Complainants or by the patient warranting any review of the continuance of the immuno suppressive drug.  This could have been possible only if any complaints or of any such symptoms were made or reported that the Opposite Party No.2 could have taken a call on the same.  No such complaint was reported after 05.03.2013 till 14.03.2013 as such there was no occasion for any review.

37.     The submission is that the entire edifice of the case having been built up on this allegation is without any basis.

38.     Learned Counsel then submits that the theory of GvHD having got aggravated on account of negligence of the Opposite Parties is unfounded inasmuch as the Complainants themselves have admitted in paragraph              3(k) and 3(m) of their Complaint that after the Cyclosporine was discontinued on 05.03.2013, it was for the first time that on the 9^th day thereafter, rashes were seen behind the ears and the patient was having loose motions.  He therefore submits that according to the Complainants themselves, the first fresh symptoms pointing out towards the emergence of GvHD was available and made known to the Opposite Party No.2 on 14.03.2013 that was noticed and has been recorded in the prescription.  On the basis of a clinical diagnosis and past history of the patient, the Opposite Party No.2 came to the conclusion that it was when the skin GvHD with less than 25% was recorded on 15.03.2013.  This diagnosis being recorded in the prescription clearly demonstrates the status of the symptom which was assessed by the Opposite Party No.2 who was possessed of the skill judging the same and he accordingly advised Cyclosporine (Necrol) 50 mg together with Betnovet ointment to be applied on the surface where the rashes were seen.

39.     He contends that this assessment made was the earliest symptom being less than 25%, at the most of grade I GvHD, and not grade IV as is being urged by the Complainants.  The submission that this assessment was incorrect by the Complainant is not based on any evidence.

50.          A perusal of the aforesaid observation, therefore, leaves no room for doubt that grade I skin GvHD had been diagnosed and Cyclosporine was advised in a tapered way for four weeks with a clear direction to stop the same thereafter.  Thus, the said administration of medicine that had to continue and was to be stopped was continued till 05.03.2013.  The allegation of the Complainants is that it is the Opposite Party No.2 who stopped the medicine.  This does not appear to be correct inasmuch as the medicine was continuing in the dosage prescribed by Vellore Hospital and the 9^th February 2013 prescription of the Opposite Party No.2 also indicates the continuance of Necrol which, according to the learned Counsel is the brand name of Cyclosporine.  Not only this, the same seems to be in accordance with the medication advised by Vellore Hospital.  On 20.02.2013 the said dosage of Necrol has again been prescribed by the Opposite Party No.2.  Thus, this contention that there was advise to stop the medicine by the Opposite Party No.2 w.e.f. 05.03.2013 onwards does not appear to be correct.

51.    What appears is that after the medicine was discontinued after 05.03.2013, there is nothing on record to indicate any prescription or consultation from the Opposite Party No.2.  No symptom or any complication seems to have been reported after 05.03.2013 till 14.03.2013 so as to construe that the Opposite Party No.2 had been negligent in not taking care of the administration of the medicine.  This gap from 05.03.2013 onwards regarding the Necrol administration of Cyclosporine, therefore, cannot be attributed as a negligence to the Opposite Party No.2 inasmuch as if no symptoms were reported by the patient nor it is alleged that any rashes or any other symptom was visible, then any further prescription of any drug or medicine does not seem to be warranted.  .

52.    Admittedly, according to paragraph 3(m) of the Complaint, the patient for the first time complained of rashes and loose stools only on 14.03.2013.  The submission made in paragraph 3(m) is extracted hereinunder:

“(m) That just within 9 days from the date of withdrawing ‘Cyclosporin’ Manavi had her first episode of developing GcHD in the form of diarrohoea and rashes behind her ear and on her back on 14^th March, 2013.  The Complainants immediately rushed her to the OPD of OP2 but OP2 took the entire thing in a very casual manner and did not start with any investigation or treatment. The OP2 did not even admit the patient to start therapeutic dose of cyclosporine. It is relevant to note that OP2 was fully aware that Manavi was at high risk of developing GVHD as her only immuno-suppressant had been tapered and stopped.  However OP2 neither started any treatment nor gave any advise about any follow up. OP2 also did not monitor or carry out any investigations. That OP2 was deficient in rendering service by failing to inform the Complainant when Manavi should be brought to hospital to be treated for GvHD. A true copy of the OPD slip is annexed and marked as ANNEXURE-C-7.”

53.    It is thus evident that the immuno suppressive drugs had been started together with steroids on 16^th March itself.  A perusal of the said submission, therefore, establishes that according to the Complainants, this was the first episode on 14.03.2013 that was reported on that day which gave rise to a suspicion of GvHD.  The Opposite Party No.2 in his prescription dated 14.03.2013 had noticed the rashes and on the very next date i.e. 15.03.2013 diagnosed skin GvHD less than 25%.  The said prescription also prescribes 50mg Necrol (Cyclosporine) dosage twice daily coupled with Betnovate ointment to be applied locally.  The contention of the learned Counsel is that this was advised without conducting any test.  The Opposite Party No.2 is an Oncologist, an expert in the field.  The past history including the discharge summary from Vellore Hospital was available before him which also recorded the presence of skin  GvHD grade I.  With his experience and expertise, the Doctor seems to have recorded that it was less than 25%.  At the time of discharge on 27.04.2013, the said skin GvHD was described as grade II which is evident from the said discharge summary which is on record. 

The contention of the Complainants, which has been consistently argued and urged that no appropriate treatment to the aforesaid diagnosis was given is an allegation made in paragraph 3(r) which is as follows:

        (r) That since no treatment required for GvHD was given to Manavi on first two crucial days on 16^th March condition worsened to diarrhea at an interval of 15 to 30 minutes, after much persistence from the Complainants she was admitted in the evening of 16^th March and she was put by Ops on prednisolone 20 mg BDS steroid (oral), budesonide 3 mg, (oral) TDS cyclosporine 50 mg BD (oral) along with antibiotics, antiviral, anti-emittic etc.

54.    In this respect the first issue is as to whether the symptom was of grade I or II or had enhanced further. Assuming that no pathological tests or investigations were immediately carried out on the 14^th or 15^th of March, 2013, yet clinically the treatment had commenced in spite of that with the administration of requisite medicines as mentioned and admitted by the Complainant in the paragraph quoted above.

55.    It may be pointed out at this stage that the tests were carried out on 21.03.2013 and upon receiving the tests, the dosages were accordingly prescribed and the medicines were administered accordingly.

56.     The grievance of the Complainants is that it is during the crucial period from 14.03.2013 onwards for the first 3/4 days that no appropriate steps were taken.  As demonstrated above, the treatment had already commenced according to the dosage prescribed.  From the literature that has been cited by the Complainants, namely, British Journal of Hematology, at the summary of recommendations item number 8 states that the dosage of 2mg per kg per day as the starting dose for grades III-IV GvHD (1A).  Thus, the dosage prescribed according to the literature cited by the Complainants is for grade II to IV GvHD.  Conducting of any biopsy has been stated therein to be important in the classical constellation of symptoms.  Learned Counsel for the Complainants states that had biopsy been conducted, the exact status of symptoms would have been decipherable and in such circumstances, it should be presumed that appropriate treatment was not given.

57.    Countering the aforesaid submissions, learned Counsel for the Opposite Party has pointed out that even assuming for the sake of arguments that a grade II GvHD had set in, the Complainants have admitted the administration of prednisolone 20mg along with BDS steroid  and other medicines w.e.f. 16.03.2013 in paragraph 3 (r) of the Complaint which has been extracted hereinabove. 

58.    Learned Counsel for the Opposite Party, therefore, is correct in his submission that requisite medicines had already been administered which matches with the suggestions made and line of treatment noted in the Journal.  It is urged that prednisolone is administered in the case of grade II-IV and therefore, even otherwise, the Opposite Party No.2 had advised the said medicine that was administered on 16.03.2013 itself. The course adopted therefore cannot be an error of judgment, as the protocol was being observed, but even if it was, there is nothing to brand it as gross medical negligence.

59.    The admission in para 3(r) of the Complaint, therefore, as reasoned out above, contradicts the stand taken by the Complainants.

60.    Proceeding further and as discussed above, discharge summary dated 12.04.2013 of the CMC Vellore leaves no room for doubt that on 30.03.2013 the grade diagnosed at Vellore was still grade II and not grade IV as alleged by the Complainants or even sought to be demonstrated with the aid of the affidavit of the CMC Vellore Opposite Party No.5, as discussed above.  The aforesaid evidence bereft of any expert evidence, therefore, in my opinion, does not in any was establish negligence much less a gross negligence as alleged by the Complainants against the Opposite Parties No.1 to 4.  The diagnosis of the treatment and the management of the patient as described in the discharge summary appears to be genuine and bonfide with no indication to any deficiency or shortcoming amounting to negligence.

61.    Finally, coming to the report of AIIMS, the same is extracted hereinunder:

Ansari Nagar, New Delhi - 110029

No.F.2-53/Medical Board/2017-Estt.(H.)                 Dated: 08.02.2018

Subject: Report of the Medical Board constituted at AllMS for expert opinion in compliance of orders dated 08.12.2017 of Hon'ble National Consumer Disputes Redressal Commission, New Delhi, vide Consumer Complaint No. 371 of 2103 titled Mayank Kumar Tilak & Ors Versus Dr. B.L. Kapur Memorial Hospital & Ors.

A medical board has been constituted by Medical Superintendent, AlIMS, on subject noted above. The chairperson and members of the board are as follows

1. Dr. Atul Sharma                                                                  Chairperson

Professor, Deptt. of Medical Oncology, Dr. BRA-IRCH

2. Dr. Manoranjan Mahapatra                                              Member

Professor, Deptt. of Hematology     

3. Dr. Sameer Bakshi Professor,                                         Member

Deptt. of Medical Oncology, Dr. BRA-IRCH

4. Dr Puneeth T                                                                      Member Secy

Department of Hospital Administration

A meeting of the board was held on Monday, 15th January, 2018 at 03.00 PM. in V.IP Consultation Room No. 13, M.S. Office Wing, ground floor, AIIMS, New Delhi.  All members attend the meeting on the aforesaid date, time and place.  The committee deliberated on terms of reference, as drafted by learned Amicus Curiae along with the medical records provided.  The Committee arrived at the following opinions :

1. Terms of Reference for the treatment during the period 09.03.2013 to 16.03.2013

1.1.        Whether the treatment of OP 2 at OP 1 in stopping the only immune suppressant, cyclosponne wet 05.03.2013 was the reasonable and appropriate line of treatment in the facts and circumstances of the case?

Opinion : Cyclosporine was stopped as per the advice and plan provided by CMC Vellore At the time of stopping cyclosponne there was no clinical evidence of GVHD (graft versus host disease) There are different approaches for duration of cyclosporine therapy in the absence of GVHD and possibly CMC Vellore approach is to continue it for about 4 months

1. Whether the clinical examination of patient and monitoring was done prior to stopping cyclosporine?

Opinion  Yes

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and supervision looking to the symptoms on 14.03.2013 itself?

If the answer is yes, whether such non-admitting of the patient was a reasonable cause in the deterioration of the patient's condition over the next few days.

Opinion: Close monitoring was needed. It could have been indoor or regularly on out patients basis (OPD). Investigations were suggested. Whether to admit or not is a decision taken by treating physician based on physical condition of patient.

1.4.        Whether Endoscopy and Biopsy were essential to be conducted by 16.03.2013?

Opinion: In a patient who is suspected of having gut GVHD, endoscopy and biopsy is preferred Occasionally if patient is not stable or fit enough to be shifted to endoscopy suite it is delayed

1.5. Whether the condition of patient on 16.03.2013 warranted the start of intravenous steroids and immune suppressant in treating the patient?

Opinion: Steroids are indicated. Intravenous is started if patient cannot accept orally.

2. Term of Reference for the treatment during the period 17.03.2013 to 20.03.20131

2.1.        Whether it was imperative for OP 2 to commence IV Methyl Prednisolone from 17.03.2013 18.03.2013 itself looking to the condition of the patient?

Opinion: No. As per hospital records she had 3 loose stools only.

2.2         Whether the tests of CMV, PCR and Endoscopy were required to be done looking to the condition of the patient?

Opinion: Yes. And as per reports the tests were done on 20.03.2013

2.3         Was the treatment given to the patient on 18.03.2013 in line with reasonable standard of treatment given to any other patient in similar condition?

Opinion: As per records patient was clinically stable with semi solid stools. So IV fluids and continuation of oral steroid was reasonable.

2.4         Whether the line of treatment should have been changed when red blood cells were detected in the stool passed as on 17 03 2013?

Opinion No

condition of the patient on the 7th day?

Opinion: Yes. Gut rest is-suggested if there is worsening of diarrhea and vomiting. If gut rest is suggested then nutritional support is also started.

2.6         Whether patient's condition on 20.03.2013 was indicative of Grade II-IV of GvHD?

Opinion: Yes.

3. Terms of Reference for the treatment during the period 21.03.2013 to 22.03.2013

3.1         Whether the drug Loperamide (which is an anti-mortality drug) was the right selection of drug as GvHD diarrhoea is secretory and is not related to motility of gut?

Opinion: Loperamide is used.

3.2         Whether OPs 2 to 4 should have carried out baseline tests ie, endoscopy, biopsy, CMV- PCR and cyclosporine level much earlier and not waited till Day 87

Opinion:           Baseline tests as mentioned could have been done earlier if there was high index of suspicion.

4. Terms of Reference for treatment during the period 24.03.2013 to 27.03.2013

4.1         Whether administering Loparamide on 25.03.2013 by OPs 2-4 led to progressive worsening of GVHD leading to the onset of paralytic ileus after 2 weeks?

Opinion: Unlikely

4.2         Whether Gancyclovir therapy was the reasonable line of treatment in the facts and circumstances of the case?

Opinion: Yes

4.3         Whether the patient was suffering from progressive uncontrolled acute GvHD as on 27 03 20139

Opinion Progressive Acute GVHD and CMV colitis

4.4.        Whether there is a standard line of treatment for patient suffering from post-operative GvHD  ______ to Acute Lymphoblast _____ the treatment differ

Opinion: Treatment guidelines and recommendations are general in nature and not specific for post transplant Acute GVHD for acute lymphoblastic leukemia.

4.5         Whether the first, second and third tine of treatment for postoperative GvHD set out in medical literature is merely a guideline or is it mandatory in nature, to be followed in all such cases of treatment of GVHD, irrespective of the specific nature of each case?

Opinion: These are guidelines and physicians have to take a call based on clinical situations and other concurrent infections and general condition of patient.

GENERAL TERMS OF REFERENCE:

5.1         Whether in the present facts and circumstances of the case the OPs 2-4 displayed a standard of care and skill which is expected of an ordinary competent medical practitioner/ specialist exercising ordinary degree of professional skill?

Opinion: Probably yes

5.2         Whether OPs 2-4 exhibited a reasonable degree of skill and knowledge and exercised a reasonable degree of care for the period 09.02.2013 to 27.03.2013?

Opinion: Yes.

5.3         Whether OPs 24 failed to exercise due care and diligence white providing treatment to Manvi which resulted in her ultimate death?

Opinion: Probably no.

62.    Learned Counsel for the Complainants urged that while answering question no.1.2 the experts have incorrectly opined as YES.  This, according to the learned Counsel     is not established on record and hence, the conclusion is wrong.  The aforesaid contention on behalf of the Complainant does not appear to be correct inasmuch as the patient had been advised stoppage of Cyclosporine by Vellore Hospital and it was stopped on 05.03.2013.  The clinical examination and monitoring had been done on 09.02.2013 and 20.02.2013 by the Opposite Party No.2 before the medicine was stopped.  Both prescriptions are on record and the dosage continued accordingly.  It is evident that between 05.03.2015 and 14.03.2015 there is nothing on record to indicate that the patient had reported any symptoms of aggravated GvHD or visited the Hospital or taken any advice from the Opposite Party No.2.  This was in all probability because she was not suffering from any complications, and it is quite probable that the patient not having any complications, did not get herself examined by the Opposite Party No.2.  Consequently, there is no error in the answer of the expert on that question.

63.    Learned Counsel then urged that the answer to question No.1.3 also indicates an error of assessment.  The contention of the learned Counsel for the Complainants is that close monitoring was needed and therefore, investigations were suggested. The admission may not have been found necessary otherwise.  It may be mentioned that admittedly no symptom of any such complication had arisen and therefore, even assuming that the Complainants had sought advice from the Opposite Party No.2, the question of further investigations arose only when the Complainants themselves admitted having reported the first episode of the symptom on 14.03.2013 as admitted in Para3(m) of the Complainant as quoted above.  The patient was admitted on 16.03.2013.  The answer to the aforesaid question, therefore, does not reflect any negligence on the part of the Opposite Party No.2.

64.    The next objection taken by the learned Counsel is that as against question No.2.1 in respect of commencement of methyl prednisolone had become necessary, the experts have noted that she had informed three loose stools only.  Matched with the records of the hospital, there appears to be a discrepancy in the number of stools noted which was 12 and 13 on that day.  However, on record it is evident that the requisite medicines were already continuing.  The experts may not have noticed the said fact of number of stools correctly but according to the treatment conducted, there is nothing to indicate that non-commencement of intravenous had added to the complications.  It is then submitted by the learned Counsel for the Complainants that against question No.2.6 there is a positive opinion that the patient’s condition on 20.03.2013 was indicative of grade II-IV of GvHD.  On a closer examination of the question, it is evident that it was framed in a way about the patient’s condition on 20.03.2013.  The opinion of experts stating “YES” seems to have been ignored, the death summary report from Vellore Hospital which records the symptom of GvHD on 30.03.2013 as grade II.  The discharge summary of the Opposite Party No.1 Hospital on 27.03.2013 also records the same.  There was no prior indication of grade II-IV GvHD to be existing on 20.03.2013.  The answer, therefore, given by the experts does not seem to be in conformity with the records.

65.    Ultimately the learned Counsel contends that the answer given to the general terms of reference, namely, question No.5.1 to 5.3 are also not correct as the credibility of the experts opinion is doubtful.  This Commission is not in a position to sit as an expert over the opinion of expert committee but even otherwise, the complainants had themselves objected to seek an expert opinion to counter the same.  Inspite of time having been granted, learned Counsel for the Complainants herself expressed the inability to provide any counter expert opinion as has been recorded in the order dated 06.02.2024 already extracted hereinabove.

66.    Thus on all counts there is hardly any material so as to completely discard the medical expert opinion brought on record on the directions of this Commission.  The expert committe report dated 08.02.2018, therefore, cannot be ignored as sought to be suggested on behalf of the learned Counsel for the Complainants.

67.    For all the reasons recorded hereinabove and in view of the submissions made and the evidence on record, no case for medical negligence is made out against the Opposite Parties No.1 to 4.  Consequently, the Complaint is accordingly dismissed.