1.       This appeal under section 19 of The Consumer Protection Act, 1986 is in challenge to the Order dated 22.06.2018 of the State Commission in complaint no. 27 of 2004.

2.       We have heard the learned counsel for the appellant (the ‘opposite party no. 1 hospital) and the learned counsel for the respondent (the ‘complainant’).  Dr. Upendra Kaul (the ‘opposite party no. 2 doctor’) present in person also makes his submissions.

We have perused the material on record.

3.       Briefly, the complainant made allegations of medical negligence and deficiency in service against the opposite party no. 1 hospital and the opposite parties no. 2 to no. 5 doctors. Opposite party no. 2 was Director, Interventional Cardiology, Electrophysiology, opposite parties no. 3 and no. 4 were Senior Interventional Cardiologists and opposite party no. 5 was Senior Resident, working in the opposite party no. 1 hospital.

The complainant was a case of wolff-parkinson white syndrome (WPW syndrome) caused by the presence of an accessory conduction pathway in the heart. This accessory pathway was responsible for episodes of fast heart beating i.e. palpitation known as paroxysmal supraventricular tachycardia (PSVT). Electrophysiology study (EPS) together with radiofrequency ablation (RFA) was performed on the complainant in a combined procedure on 23.12.2002. Heart block occurred during the procedure, and a temporary pacemaker was installed. A permanent double chamber pacemaker was thereafter installed by a separate operation on 26.12.2002. The permanent pacemaker then malfunctioned, which necessitated another surgery on 11.02.2003 for implantation of a new lead to make the pacemaker functional.

The allegations of the complainant were that the procedure of RFA was undertaken without disclosing to him and taking into consideration the report of the EPS; it was done without his knowledge or consent under the guise of EPS; other options for treatment which were less risky and less life-threatening were not considered before taking up RFA; in the process of undertaking RFA heart block was caused; the temporary pacemaker was implanted carelessly and it pierced the heart; thereafter the permanent pacemaker was also implanted without diligence; the pacemaker, which per se became necessitated because of the negligence during the RFA in the first place, too malfunctioned causing further damage to the heart and also necessitating another surgery for its rectification.

4.   The State Commission during the course of the proceedings referred the matter for expert opinion to Maulana Azad Medical College, New Delhi.  A board of doctors comprising of a professor in cardiology, a professor in ctvs and a professor in medicine gave its opinion dated 23.03.2012 wherein it concluded that “there seem to be no negligence from BATRA Hospital and/or the attending Doctors anytime during entire course of treatment and operation of petitioner”.          

It but also made an observation that “the documentation would have been more adequate if we were provided with EPS and ECG traces, the EPS-RFA trace provided to us vide letter (3027-30) dated 16-02-2012 is actually a fluoroscopic image and not an EPS trace”.

5.   The State Commission on appraising the case did not find good grounds to conclusively determine negligence or deficiency on the part of the opposite parties no. 2 to no. 5 doctors.

It however inter alia observed that “in this Commission’s Order dated 10.02.2012, OP-1 hospital failed to place on record ECG traces report as called for by the experts. Nothing has been placed on record by the OP-1 Hospital to show that the same was ever handed over to the patient or his relatives/attendants. It goes to show that the OP-1 Hospital has something to conceal from the world. An adverse inference therefore, has to be drawn against it” and took an adverse view of the ECG report strip not being made available for the experts.

It also questioned the consent(s) taken by the opposite party no. 1 hospital.  Its critique on this point is being reproduced below:

23. Reverting to the case in hand, Ops placed on record a consent form dated 23.12.2002 showing the consent having been taken for EPS. The contents of this form have been discussed above It is the admitted case of the parties that after electro physiology study (EPS), Radio Frequency Ablation is done. In other words this a diagnostic as well as therapeutic procedure. As opined by the experts in case risk of RFA procedure following the EPS study is higher than anticipated it is to be discussed again the with patient when he is conscious. In the present case EPS study clearly showed that the accessory pathway was close to the main conduction pathway. There definitely was a risk of blocking of the heart. No such information was given to the patient after the treating doctors noticed the closeness of the accessory pathway and the main conduction pathway. Clearly, the patient was conscious at that time. Doctors also did not find it necessary to ask the patient to call his relatives/ attendants so as to explain the risks of the procedure. Patient was never told the seriousness of the procedure. He could call his wife only when he had suffered the problem. Be that as it may, consent form dated 23.12.2002 does not disclose the risk of blocking of the heart in doing ablation when the accessory pathway is close to the main conduction pathway. The language used in the said consent form is highly deceptive in that it does not clearly spell out that the procedure is both diagnostic and therapeutic it simply uses the words “medical diagnostic procedure”. The words "EPS” are not accompanied by the words "RFA". In the absence of the words 'RFA' it is not indicated that ablation is included in the procedure. 

24. Another consent form dated 24.12.2002 is a verbatim copy of the consent form dated 23.12.2002. OPs failed to indicate to the patient that now they were going for another treatment. Consent form dated 24.12 2002 also mentions only EPS procedure. There is a third consent form which is again dated 24.12.2002 but in the column of procedure it reads "for - PPI". Shockingly this form as well is also a verbatim copy of the earlier two forms. It does not disclose to the patient that permanent pacemaker implantation was being done on him. There is fourth consent form which is dated 11.02.2003 showing in the column of procedure, "Thoracotomy". Again this form is a verbatim copy of earlier three forms. It does not disclose to the patient or his relatives/ attendants that an open surgery was going to be performed on the patient. In a mechanical manner the OP1 Hospital used one consent form without disclosing the different kinds of risks involved. The complainant and his relatives/ attendants remained in dark all along.

6.   For these two acts i.e. failing to place on record the ECG strips report before the Commission or making it available for the experts as well as the lack of proper informed consent, the State Commission held the opposite party no. 1 hospital deficient in service and ordered it to pay compensation of Rs. 10 lakh to the complainant with interest at the rate of 7% per annum from the date of institution of the complaint with the stipulation that if the compliance was not made  within 30 days the amount shall then carry interest at the rate of 12% per annum.

7.   Learned counsel for the opposite party no. 1 submits that written consent dated 23.12.2002 was taken for performing EPS and RFA together. Subsequently, written consent dated 24.12.2002 was taken for installation of the permanent pacemaker.

Regarding the ECG strips report learned counsel submits that as per his instructions the same was handed over to the patient.

Submission of the learned counsel is that, as has been observed in the expert opinion from Maulana Azad Medical College and as has been seen by the State Commission in its appraisal, there is no medical negligence or deficiency on the part of the opposite party no. 2 doctor or the other members of his team i.e. opposite parties no. 3 to no. 5 doctors.

Further submission is that the State Commission has erred in returning findings of deficiency on the opposite party no. 1 hospital in respect of non-supply of ECG strips report and not taking proper informed consent. 

8.       Learned counsel for the complainant submits that there is no mention of negligence or deficiency on the part of the opposite party no. 2 doctor and the other member of his team i.e. opposite parties no. 3 to no. 5 doctors in the expert opinion from Maulana Azad Medical College and the State Commission also appears to have implicitly agreed with the same since it has not returned findings of negligence or deficiency on the part of the opposite party no. 2 to no. 5 doctors. 

He further submits that the consent on 23.12.2002 was taken for EPS alone and not for RFA. EPS is a diagnostic tool which also inter alia becomes a crucial input for giving informed consent for RFA, which is the actual treatment. The consent was given only for EPS which was the diagnostic study and not for the treatment by way of RFA, it was much rather needed that the EPS be available for making an informed decision on whether or not to undertake RFA at all after weighting the risks attached with RFA and the other options available for treatment. Learned counsel further submits that the consent for pacemaker was a forced necessity which occurred due to negligence and deficiency in conducting the RFA in the first place. But here also the different makes etc. and respective pros and cons of the various makes of pacemaker available was never discussed or explained.

He also submits that ECG strips report was consciously concealed by the opposite party no. 1 hospital and not supplied for the experts from Maulana Azad Medical College though it was material medical record for evaluating the matter.

Learned counsel however submits that since the State Commission has not determined medical negligence or deficiency on the part of the treating doctors and its findings have not been challenged by the complainant by way of appeal, he does not want to dwell or contend further into this arena at this stage even though in his opinion there is sufficient material on record to demonstrate negligence and deficiency on the part of the opposite party no. 2 doctor and his team of doctors.

9.       In rebuttal learned counsel for the opposite party no. 1 hospital submits that experts comprising of a professor in cardiology, a professor in ctvs and a professor in medicine under Maulana Azad Medical College which is a premiere institution did not find medical negligence or deficiency after going through the medical record. Unbiased opinion of senior impartial professionals cannot be overridden without cogent reasons, which were not at all forthcoming before the State Commission.

He but fairly submits that only ‘EPS’ is written by hand in the consent form and ‘RFA’ is not written at all therein and as such an obvious inference can be made that the consent was for ‘EPS’ alone and not for a combined ‘EPS–RFA’ procedure.

10.     Opposite party no. 2 doctor in person makes his submissions that once the complainant with WPW syndrome, diagnosed by ECG changes, has episodes of palpitation and documentation of PSVT is there, as in the case of the complainant, the standard medical recommendation is to undertake EPS and RFA together. The EPS in such cases is performed not to confirm the diagnosis, which is obvious from the ECG and the documentation of the medical history, but to locate the accessory pathway for ablation. Therefore such patients are advised EPS and RFA as a combined procedure. The complainant had been asked to make deposit for RFA i.e. Rs. 30,000/- and not for EPS alone the cost of which at that time was Rs. 20,000/-.  The complainant was not charged for the cost of EPS since combined EPS and RFA was undertaken and he was charged only for RFA at Rs. 30,000/- and he himself made the requisite deposit in advance. Doing EPS alone just to confirm the presence of accessory pathway in such cases is not required or recommended. The complainant was taken for EPS - RFA combined after his written consent. The procedure was undertaken with local anaesthesia, and not under sedation. Occurrence of heart block is a rare complication in RFA but if it occurs it needs to be immediately addressed and treated by temporary pacemaker. A temporary pacemaker was kept readily available, as is done as a matter of rule always, to meet such rare complication in case the event occurs. Subsequently a permanent pacemaker was also installed, also with written consent. It was with the complainant’s complete knowledge and willing consent that the RFA treatment was undertaken together with the EPS. He however fairly submits that only ‘EPS’ had been written in the consent form though it ought to have been ‘EPS – RFA’. He submits that this might be probably due to remissness on the part of the concerned doctor who had written on the consent form. That being as it is, he admits that the ‘RFA’ too ought to have been written on the consent form.

11.     On a query from the bench learned counsel for the opposite party no. 1 hospital fairly admits that the consent form is a pre-printed form adopted by the opposite party no. 1 hospital in which some portion has been left blank which is meant to be filled in by hand by the doctor taking the consent. In the blank portion only ‘EPS’ had been written and there is no mention of ‘RFA’ therein.  Except for ‘EPS’, written in ink by hand, there is no other comment or remark of any nature. He also fairly admits that though places were assigned for the signatures of the patient and the witness on the pre-printed consent form, there was no place assigned for the signatures of the doctor who was taking the informed consent from the patient. There was no signatures or identification of the doctor / person who had taken the consent anywhere on the consent form at any place. 

12.     We note that experts under the aegis of Maulana Azad Medical College gave an opinion that no medical negligence or deficiency was attributable to the treating doctors i.e. the opposite party no. 2 doctor and the other members of his team. The State Commission has not found any cogent reason to disagree with this opinion. The complainant has not challenged the same. Learned counsel for the complainant refrains from entering into this arena. As such there appears no need to examine this issue further.

13.     We also note that there is no explanation whatsoever in respect of the ECG strips report not being supplied for the experts in Maulana Azad Medical College and the absence of which has not been satisfactorily explained either before the State Commission or even in the present appeal before this Commission. This is clearly a deficient as well as deceptive & unfair act, moreso when it is the opposite party no. 1 hospital’s own case that this was a case of “WPW syndrome (diagnosed by ECG changes)” as written at various places in its written version and the experts have also recorded that “the documentation would have been more adequate if we were provided with EPS and ECG traces, the EPS-RFA trace provided to us vide letter (3027-30) dated 16-02-2012 is actually a fluoroscopic image and not an EPS trace”.

14.     Regarding the consent for the RFA we note that two consents dated 23.12.2002 and 24.12.2002 were taken. Both had signatures of the patient. The form dated 23.12.2002 had the signatures of a witness, the form dated 24.12.2002 had no such signatures of any witness. In both forms only ‘EPS’ is written. If the procedure was combined for ‘EPS-and-RFA’ the same ought to have been written. In neither form there is any way of identifying the doctor / person who wrote these three alphabets ‘EPS’ in the blank portion and took the signatures of the patient and a witness (in one of them) at the assigned places on the forms. Pertinently there is no assigned place in the forms for the signatures and details of the doctor(s) who took the consent. There are no other comments or remarks of any nature whatsoever. No comment or remark etc. as may go to show that it was a proper informed consent is there. It is not clear which doctor(s) actually took the consent after inter alia explaining the risks involved and discussing other alternative methods of treatment including by medication alone and not by any invasive procedure. It is also not clear whether these forms were filled up only as a mandatory clerical requirement just for maintaining the record and not to meaningfully serve the avid object as it ought to have, moreso when the procedure was undertaken on 23.12.2002 and after a consent dated 23.12.2002 having already been taken but yet another similar consent was again taken on 24.12.2002. It is unclear whether the risks were objectively and candidly explained and the alternative options of treatment were explained and discussed.

The consent dated 24.12.2002 for the pacemaker was just a formality to the extent that the pacemaker had become essential after heart block occurred during RFA. However here too only ‘FOR – PPI’   (permanent pacemaker implantation) was written in ink by hand with no other comment or remark, only the patient’s attendant had signed at the assigned place, the place assigned for the signatures of a witness was blank, there was no place assigned on the form for the signatures and details of the doctor(s) who took the consent, there was no signatures or identification of the doctor(s) anywhere on the form, and there was no comment or remark to show whether the alternatives regarding availability of various makes of pacemakers and their respective pros and cons were ever discussed. It is not clear whether the pacemaker of the make of the opposite party no. 1 hospital’s choice was forced on the complainant with no informed choice, which is materially relevant considering that the pacemaker which was installed subsequently gave problems of malfunctioning.

Similar position of the consent taken on 11.02.2003 is noticed, with just ‘Thoracotomy’ written in the blank portion with ink by hand, with no other comment or remark, with only the signatures of the patient at the assigned place and no signatures of any witness, and with no signatures or identification of the doctor(s) / person(s) who took the consent.

The State Commission has very aptly critiqued these four (04) consent forms dated 23.12.2002(‘EPS’), dated 24.12.2002(‘EPS’), dated 24.12.2002(‘FOR-PPI’) and dated 11.02.2003(‘Thoracotomy’) in paras 23 and 24 of its Order (reproduced in para 5 hereinabove).

All this is clearly deficient as well as deceptive & unfair.  As such we see no reason to disagree with the State Commission in imposing compensation on the opposite party no. 1 hospital. However the State Commission ought to also have considered making order under section 14(1)(f) of the Act 1986 to discontinue the unfair trade practice.

15.     Before we could dwell further into this aspect learned counsel for the opposite party no. 1 hospital submits that the opposite party no. 1 hospital will forthwith re-visit its pre-printed consent forms and make sure that there is an assigned place therein for the signatures and identification of the doctor(s) taking the consent. Additionally, it will take due care to make sure that the requisite remarks or comments as may be apt are duly entered at the time of taking consent so that the document becomes a meaningfully speaking document equal to serve its intended purpose and leaves no ambiguities or questions.

Learned counsel further admits that the patent lapse in respect of consent necessitates compensation and submits that the opposite party no. 1 hospital will pay the compensation of Rs. 10 lakh with interest at the rate of 7% from the date of institution of the complaint as awarded by the State Commission. He however requests that the penal interest of 12% imposed by the State Commission may be dispensed with.

Learned counsel also submits that the amount deposited with the State Commission in compliance of this Commission’s Order dated 06.11.2018 along with interest as any accrued thereon may be forthwith released to the complainant and that the balance awarded amount shall be made good within eight weeks from today.

16.     Learned counsel for the complainant submits that since the case was appealed by the opposite party no. 1 hospital he will not press for penal interest of 12% for the delay in making compliance.

17.     In the wake of the above submissions nothing further remains to be adjudicated and the appeal is disposed of with the directions that for the deficiency in service and the unfair trade practice in suppressing the ECG traces report and in not taking proper informed consent the opposite party no. 1 hospital shall pay an amount of Rs.10 lakh to the complainant with interest at the rate of 7% per annum from the date of institution of the complaint till actual realization.

The amount as any deposited with the State Commission in compliance of this Commission’s Order dated 06.11.2018 along with interest as any accrued thereon shall be forthwith released by the State Commission to the complainant.

The residual amount of the award, as being firmed-up herein, shall be made good by the opposite party no. 1 hospital within eight weeks from today, failing which the State Commission shall forthwith undertake execution, for ‘enforcement’ and for ‘penalty’, as per the law. 

The complainant has since expired and has been substituted by his widow namely Smt. Jyoti Bezbarua Goswami. As such all payments shall be made to her.     

18.     The Registry is requested to send a copy each of this Order to the parties in the appeal and to their learned counsel within three days. The stenographer is requested to upload this Order on the website of this Commission immediately.

‘Dasti’, in addition, to facilitate timely compliance.