State Consumer Disputes Redressal Commission
Raghavendra Anantrai Mehta vs Dr.Darshan Jhala on 1 June, 2010
CONSUMER DISPUTES REDRESSAL COMMISSION CONSUMER DISPUTES REDRESSAL COMMISSION MAHARASHTRA STATE, MUMBAI Date of filing : 10/05/2002 CONSUMER COMPLAINT NO. 165 OF 2002 Date of order : 01/06/2010 Raghavendra Anantrai Mehta R/at B-601, Gokulnagari No.I, Western Exp. Highway, Kandivali (E), Mumbai 400 101. Complainant V/s. Dr.Darshan Jhala 1/2, Kumkum, Opp. Lali Bar and Restaurant, Near Topiwala Cinema, Goregaon (W), Mumbai 400 062. Opposite Party Quorum : Shri P.N. Kashalkar, Honble Presiding Judicial Member
Mrs.S.P. Lale, Honble Member Appearance :
Mr.Lalitkumar Jain, Advocate for the complainant.
Mr.Y.C. Naidu, Advocate for the O.P.
-: ORDER :-
Per Shri P.N. Kashalkar, Honble Presiding Judicial Member This complaint has been filed by Advocate Mr.Raghavendra Anantrai Mehta, who is Ex-Judicial Officer of the State of Maharashtra and has started practice after retirement of judicial service after attaining age of superannuation. He was also working as Director of Judicial Officers Training Institute and was Chairperson of Debts Recovery Appellate Tribunal till the age of 65 years. O.P./Dr.Darshan Jhala is Cardiologist and he has private clinic at Kumkum, Opp. Lali Bar and Restaurant, Near Topiwala Cinema, Goregaon (W), Mumbai. Dr.Jhala was also attached to Lilavati Hospital and Jaslok Hospital, Mumbai. According to the complainant O.P. performed two operations on the complainant for the same purpose at the same spot just below the collar bone for implantation of pace maker in Lilavati Hospital firstly on 21/06/2001 and secondly on 23/06/2001 and in performing operations he alleged that there was medical negligence on the part of O.P. He pleaded that while going to the office on 20/06/2001 he felt giddiness and uneasiness and he straightway went to Dr.Baliga Nursing Home, Goregaon, where he was first examined by Dr.V.G. Nagvekar and secondly by O.P./Dr.Jhala who was summoned by Dr.Nagvekar. O.P. advised him to get admitted for implantation of pace maker. He stated that such permanent implantation is very common and within 3-4 days complainant would be in a position to pursue his normal duties and the cost would not exceed Rs.1,50,000/-. He further informed the complainant that implantation requires very minor operation and it could be performed in the Hospital like Lilavati or Jaslok. So, complainant went straightway to Lilavati Hospital where he was admitted as patient of O.P. on 20/06/2001.
On the next day, O.P. with Dr.DSilva performed operation on the complainant for implantation of pace maker. O.P. himself selected the pace maker and the final bill showed that pace maker costed Rs.1,50,000/-. Inspite of operation and implantation of pace maker, complainant pleaded that he was not feeling normal. When complained O.P. on 23/06/2001 informed the complainant that pace maker was not functioning properly and therefore, repositioning was required to be done. Accordingly on 23/06/2001 repositioning was done. Repositioning required removal of earlier stitches, operation, admission in ICU and the same procedure and same treatment. Complainant pleaded that O.P. was well aware on 21/06/2001 itself that there was not only deficiency but gross negligence on the part of Dr.Jhala in performing first operation. Normally, he would have been discharged on 23/06/2001 itself but, in view of complaints and reading on the monitor on 23/06/2001 complainant was not discharged, but was operated second time resulting into mental and physical agony besides additional burden of expenditure. He enclosed copy of bill (Exhibit-A) in support of his case. According to the complainant he was discharged from Lilavati Hospital on 27/06/2001 as per Discharge Certificate (Exhibit-B).
O.P. had called complainant to his Goregaon Clinic on the evening of 01/07/2001 for check-up. He accordingly attended the Clinic and narrated the complaints that he was not fully comfortable despite second operation. On examination Dr.Jhala summoned Programmer from Andheri and with his assistance it was found that PPM was not capturing the heart. According to O.P. if PPM was not capturing heart, purpose of implantation was not fulfilled. So, complainant was bound to have same consequential problems. Complainant pleaded that O.P. then called him in Jaslok Hospital on next day i.e. on 02/07/2001 at 8.00 a.m. He examined him in Jaslok Hospital and he told him very quietly that repositioning for the third time was necessary and he would do so in Jaslok Hospital. According to the complainant, O.P. knew that PPM was not capturing heart. He also knew after visit of manufacturers representative that complainant was suffering from suspected mirco displacement of lead. Therefore, operation for third time called as repositioning was inevitable. According to the complainant, O.P. was alone responsible for this contingency. But, in order to suppress deficiency, negligence and carelessness on his part, he asserted that initial observation in the Hospital was necessary. O.P. addressed a letter dated 03/07/2001 to the Jaslok Hospital and asked them to admit complainant/Mr.Raghavendra Mehta in ICU in E clause under his care and Exhibit-C is said copy. The complainant was admitted in Jaslok Hospital for repositioning and not for observations if any. According to the complainant, he therefore lost faith in the O.P. He wanted to simply rectify the mistake he had committed initially. So, the complainant did not want operation at the hands of O.P. third time.
He then contacted Dr.B.K. Goyal, Dean of Bombay Hospital on 03/07/2001. On examination Dr.Goyal found that pace maker implanted and repositioned was not at all functioning and complainant was surviving on his own. He informed the complainant that reposition on third time was inevitable and on his advice, he got admitted in Bombay Hospital on 04/07/2001 to set right the pace maker to reposition it and to prevent displacement of lead by means of an anchoring rod which cost Rs.20,000/-. This operation was performed by Dr.Goyal and complainant was discharged on 11/07/2001. Exhibit-D is the Discharge Certificate issued by Bombay Hospital. According to the complainant, O.P. handled his case improperly and carelessly in the initial operation as well as in the subsequent operation and therefore, he was guilty of deficiency in service and gross negligence. He had to suffer at the age of 67 mental torture and physical torture besides huge financial burden. He asserted that initial negligence resulted into prolonged treatment and permanent injury. He had therefore issued legal notice dated 14/12/2001 to the O.P. calling upon him to pay damages. Exhibit-E is the said notice. Notice was also issued to Dr.Vijay DSilva. Dr.DSilva informed that he was simply intensivist standby during the procedure for Cardio Respiratory Monitoring and to deal with any emergent situation if any. The complainant, therefore, filed consumer complaint only against Dr.Darshan Jhala and he has claimed damages of Rs.6,37,141/- as per particulars given in Exhibit-G. He had filed affidavit and documents in support of his case.
Dr.Darshan Jhala filed written statement and pleaded that complaint involves complicated issues of factual, expert, medical and legal nature. So, this complaint cannot be conducted or decided in summary and speedy proceedings under the provisions of Consumer Protection Act,1986 and it is better that the case is adjudicated by the Civil Court, where evidence can be led during full-fledge trial. He pleaded that complaint is totally based upon presumptions and conjectures and not based on any valid and cogent documents. The complaint is totally frivolous, vexatious and should be dismissed with costs under the provision of Section 26 of Consumer Protection Act, 1986.
According to O.P. he is qualified, trained and experienced Cardiologist. O.P. had acted with due care, caution, diligence and competence while attending the case of patient. O.P. has acted in accordance with the prevalent standards of reasonably competent medical person while attending the case of the patient (complainant who has been referred as patient by the O.P.). He pleaded that correct and adequate technique was used and optimal diagnosis was made considering the circumstances of the case and within the parameters of the information available at the relevant time. O.P. pleaded that he had attended Dr.Baliga Nursing Home, Goregaon on the request received from said Nursing Home, where he examined complainant who was having history of complaint of disturbed heart beats/rhythm i.e. heart block. The patient is the known case of I.H.D. with H.T. besides other age related cormorbid conditions. O.P. carried out necessary clinical examination. Clinical setting of the patient indicated that implantation of PPM was required. O.P. pleaded that Dr.Gujrathi also accompanied with him. He explained to the patient that he would be able to implant PPM only at such Medical Institution where he was attached and where he was having necessary facilities. So, he suggested names of Jaslok Hospital or Lilavati Hospital. He told that 3-4 days would be sufficient to recoup from the operation if there are no complications following the operation. He told patient that PPM would approximately cost Rs.1,50,000/- which would be purchase price of pace maker besides he will have to pay operation fees, professional fees, operation theatre charges, Laboratory charges, ICCU charges, Bed charges, etc. Patient told O.P. that he was adequately covered under the Medi-claim Insurance. He pleaded that after complainant got admitted in Lilavati Hospital he along with Dr.DSilva carried out procedure of implantation of PPM on 21/06/2001. In the case of complainant he had implanted optimal type of PPM of reputed manufacturing company. On 21/06/2001 PPM was implanted and procedure was carried out uneventfully. The patient was progressing well until 4th day post-procedure for the first time, he found that the cardiac monitor to which the patient was hooked up detected and displayed minor disturbance in cardiac rhythm. O.P. pleaded that patient was otherwise in good health. It was suspected that patient heart was not capturing signals from PPM (possibly due to micro displacement of lead or acute rise in threshold). O.P. pleaded that these are known phenomena in any implantation. O.P. pleaded that these are well known complications occurring post-operation procedure. On noticing these facts, he immediately summoned manufacturers representative and reprogramming of PPM was carried out. However, it was found that PPM was not capturing the heart. O.P. therefore, advised necessary tests which were carried out under his supervision to rule out other causes leading to the complications.
O.P. pleaded that he had explained the condition not only to the patient but also to the relatives of the patient and also to Dr.Gujrathi, family doctor of patient. He also told patient, his relatives and Dr.Gujrathi that repositioning would be required. Accordingly, repositioning was done uneventfully. O.P. pleaded that at the time of discharge of patient, patient was directed to follow-up for routine check-up. Accordingly on 01/07/2001 patient met him for routine follow-up. He examined the patient, carried out necessary investigations to confirm the functioning of PPM but in the investigation, it was detected that heart was once again not capturing signals intermittently. O.P. explained the condition to the patient and advised reprogramming of PPM. Manufacturers representative was immediately summoned and reprogramming of the PPM was carried out. Problem was corrected by varying the voltage of PPM. O.P. pleaded that as per mutual convenience patient was given necessary appointment immediately on the following day in the Jaslok Hospital to confirm the proper functioning of the PPM and to re-check the PPM lead position. O.P. pleaded that patient was taken up for necessary investigation. Investigation revealed that patient was suffering from suspected micro displacement of lead or acute rise in threshold which would require initial observation as an indoor patient under on-line monitor followed by a Planned/SOS procedure for repositioning of the lead or even change of lead. This situation was explained to the patient by O.P. but thereafter, patient did not turn up for repositioning of the lead and he has simply sent registered legal notice through his Advocate on 14/02/2001 much to his shock and surprise. He gave reply through his Advocate on 23/02/2001. According to the O.P. he was not guilty of medical negligence of any kind. This type of complication arises in any other case of similar nature. O.P. pleaded that at the relevant time the implanted PPM was intermittently failing to capture heart. O.P. pleaded that failure to capture the heart intermittently most often is detected on ECG and does not usually produce symptoms. O.P. pleaded that eco screening and fluoroscopy was carried out by Dr.Aasit Shah, Consultant Cardiologist by way of second independent opinion to confirm all the possibility of macro lead displacement. O.P. pleaded that technique adopted at the Bombay Hospital is an alternative back-up technique and not necessarily a first line method of managing patient displaying clinical setting such as that of complainant. O.P. pleaded that standard medical texts, guidelines of the reputed international associations/medical experts clearly evidenced that O.P. had adopted the optimal line of treatment at all times. O.P. therefore pleaded that complaint is mischievous and should be dismissed with costs.
Rejoinder was filed by the complainant denying the averments made by Dr.Jhala. In rejoinder complainant asserted that on consultation with Dr.Goyal, Dean of Bombay Hospital on 03/07/2001 he was operated on 04/07/2001. The insertion site was required to be changed in order to prevent dislodgement or the displacement of lead, anchoring rod costing Rs.20,000/- was also used. According to the complainant use of anchoring rod in the situation and circumstances created by the O.P. was necessitated. He asserted that repositioning of pace maker for third time was inevitable and he got it done at the hand of Dr.Goyal. He reiterated that Dr.Darshan Jhala was guilty of deficiency in service and his complaint should be allowed.
We heard submissions of Mr.Lalitkumar Jain, Advocate for the complainant and Mr.Y.C. Naidu, Advocate for the O.P. extensively.
Now following issues arise for our determination and our findings thereon are as under :-
ISSUE FINDINGS
1. Whether complainant proves that in conducting No operation for implantation of pace maker by Dr.Darshan Jhala first on 21/06/2001 and secondly On 23/06/2001 O.P. has been guilty of medical negligence or was deficient in rendering services?
2. What order if any? Complaint stands dismissed.
REASONS Complainant has filed his own affidavit and has relied upon Discharge Card of Lilavati Hospital and Jaslok Hospital.
Some documents are appended along with complaint to show that complainant had taken treatment in these hospitals and he had paid fees and bills of the hospitals and that ultimately, third operation was performed by Dr.B.K. Goyal at Bombay Hospital.
However, complainant has no where adduced expert evidence of any expert from the field. The complainant is relying upon his own affidavit and documents and simply logically questioning Dr.Jhalas competence. According to the complainant when Dr.Jhala had performed first operation on 21/06/2001 at Lilavati Hospital, he had performed the operation improperly and therefore, on 23/06/2001 second operation was required to be performed by Dr.Jhala, which he performed in Lilavati Hospital. It was performed for repositioning of PPM. Then he was discharged from the hospital on 27/06/2001. Inspite of repositioning in terms of two operations, complainants grievance was that he was not feeling comfortable or normal. The programmer of manufacturer was called. In the course of examination reported that PPM was not capturing the heart. This was opined on 01/07/2001. So, O.P. asked the complainant to come to Jaslok Hospital on 02/07/2001 to confirm the proper functioning of PPM and to re-check the PPM lead position. On 02/07/2001 complainant went to Jaslok Hospital. After examination, Dr.Jhala asked him to get admitted in ICCU in Jaslok Hospital. Patient i.e. complainant however did not approach Dr.Jhala in Jaslok Hospital. He straightway went to see Dr.Goyal, Dean of Bombay Hospital on 06/07/2001, who opined that third operation or repositioning of PPM was inevitable and accordingly on 07/07/2001 PPM was repositioned by Dr.Goyal in Bombay Hospital with support of 4068 : Medtronic Capsure Lead and peel away introducer. On 11/07/2001 complainant was discharged from Bombay Hospital. Giving all these details, complainant asserted that there was medical negligence on the part of Dr.Jhala/O.P. herein. We reiterate that no expert evidence has been adduced by the complainant in support of his case of medical negligence on the part of O.P./Dr.Jhala.
As against this O.P. has filed his own affidavit. He has relied upon number of rulings of Honble Supreme Court as well as the National Commission and he has also filed affidavit of Dr.Sushil Chandra Munsi, who is qualified Consultant Cardiologist of Mumbai. Dr.Munsi had gone through the complaint of Shri Raghvendra Mehta along with annexures and also gone through the written version of Dr.Darshan Jhala, rejoinder of complainant/Shri Mehta and documents i.e. certificate issued by Dr.V.C. Nagvekar and Discharge & Follow-up Card issued by Baliga Nursing Home and after reading all those documents, independent expert Dr.Munsi clearly gave his expert opinion on affidavit as under :-
a) Patient had evidence on 2nd degree A V Block on initial presentation.
b) Decision to implant a Dual Chamber type of pace maker was as per guidelines laid down by world authorities like ACC/AHA/NASPE and is our usual practice.
c) Pacemaker implantation was properly performed and pacing system was functioning properly at the time of first implantation as evidence from Device Tracking Registration Form dated 21/06/01.
d) Subsequent problem of pacing failure was immediately accurately diagnosed precluding any inconvenience and harm to the patient and required further investigations which were done in a timely manner. e) Decision to reposition the same lead was appropriate as at this point in time lead
replacement using a different type of lead (screw in lead) was not advisable because of possibility of increased morbidity and complications associated with a screw in lead.
f) The decision to reprogram the pacemaker at follow up visit was proper and done in a timely manner.
g) The sign of minor disturbance in cardiac rhythm, which was detected and displayed on the cardiac monitor on 4th day post procedure, was rightly diagnosed as indicative of capture failure either due to minor displacement of lead or acute rise in threshold. In either situation the relevant lead has to be repositioned. Replacement of lead is not the first line of treatment. h) Advise given to the patient as regarding admission to hospital for observation at the time of detection of inadequate pacing for the second time was proper and in the best interest of the patient. It is only after appropriate
investigations and monitoring that a definite diagnosis can be concluded. Such investigations and monitoring is done in a well equipped ICCU in an indoor setting. Further at such stage medical treatment with cortico-steroids may be considered as a line of treatment instead of resorting to invasive procedures like lead replacement.
So, as against the sole affidavit of complainant/Shri Raghavendra Mehta, we have got affidavit of Dr.Jhala himself and further affidavit of expert i.e. Dr.Sushil Munsi, who has categorically ruled out the allegations of medical negligence on the part of Dr.Jhala. Dr.Munsi has categorically stated that protocol and procedure adopted for implantation of pace maker by Dr.Jhala in the case of Shri Mehta was proper. Pacing system was functioning properly at the time of first implantation as evidenced from the Device Tracking Registration From dated 21/06/2001. He also in his affidavit stated that subsequent problem of pacing failure is accurately diagnosed and same required further investigation which was done by Dr.Jhala timely. Decision to repositioning the same lead was appropriate and repositioning was rightly done and decision to re-programme the pace maker was proper and done in timely manner. According to Dr.Munsi, sign of minor disturbance in heart rhythm which was detected on the cardiac monitor on 4th day post procedure was rightly diagnosed as indicative of capture failure either due to minor replacement of lead or acute rise in threshold. In either situation, relevant lead has to be repositioned. So, Dr.Munsi mentioned that advice given to the patient regarding admission to the hospital for examination at the time of detection of inadequate pacing for the second time was proper and in the best interest of patient. It was only after appropriate investigations and monitoring that a definite diagnosis can be concluded. Such investigations and monitoring is done in the well equipped ICCU in an indoor setting. Further at such stage medical treatment with cortico-steroids may be considered as a line of treatment instead of resorting to invasive procedures like lead replacement. According to Dr.Munsi, protocol followed by Dr.Jhala was proper and he had not exhibited any lack of medical professional skill in advising complainant to undergo one after another operation and he had not done anything wrong when he had suggested the complainant to get admitted in Jaslok Hospital for third operation for repositioning of PPM since he found that PPM was not capturing signals from the heart. Dr.Jhala had suggested to admit in Jaslok Hospital ICCU on 03/07/2001 for repositioning (second time) of PPM. This was the correct advice given to the complainant by Dr.Jhala looking to the facts and circumstances of the working of pace maker in not capturing signals from the heart. For that purpose, repositioning operation was suggested when it was found to be inevitable. The complainant was not satisfied with the suggestion given by Dr.Jhala. Hence, he approached Dr.Goyal, Dean of Bombay Hospital, who on examination and consultation opined that second time repositioning operation was inevitable and ultimately on 07/076/2001 PPM was repositioned with the support of 4068 : Medtronic Capsure Lead and peel away introducer. What we are finding that the opinion given by Dr.Jhala to the complainant that second time reposition of PPM was required to be done was the correct opinion given by Dr.Jhala to the complainant, but any how, complainant was not satisfied with the suggestion given by Dr.Jhala to him and he rushed to Dr.Goyal in Bombay Hospital, who also confirmed that PPM was required to be repositioned and accordingly on 07/07/2001 he had conducted operation on the complainant in Bombay Hospital and his PPM was repositioned with the support of 4068 :
Medtronic Capsure Lead and peel away introducer and ultimately, complainant was discharged from Bombay Hospital on 11/07/2001.
Thus, the advice of Dr.Jhala given to the complainant on 2 & 3/07/2001 is found to be proper and appropriate and same suggestion was given by Dr.Goyal to the complainant on 06/07/2001 when he consulted latter in Bombay Hospital. It must be clearly mentioned that suggestion/recommendation given by Dr.Jhala as such expert in cardiologist was in toto confirmed by Dr.Goyal, another expert from Bombay Hospital.
He also concurred with Dr.Jhala when he suggested to the complainant on 06/07/2001 that third operation for second time repositioning of PPM was required to be done and advised complainant to get himself admitted in Bombay Hospital where Dr.Goyal on 07/07/2001 conducted operation on complainant for repositioning of PPM with the support of 4068 : Medtronic Capsure Lead and peel away introducer. In the circumstances, we are of the view that there was no deficiency of service on the part of Dr.Jhala and Dr.Goyal concurred with the opinion given by Dr.Jhala so far as second repositioning of PPM is concerned.
There is no evidence adduced by the complainant to prove that Dr.Jhala had in fact initially implanted pace maker incorrectly, wrongly or at a wrong place of chest of the complainant or in the collar bone of the complainant. This sort of proof should have been adduced by the complainant in support of his case. But, complainant has not adduced any proof of any expert from medical field and on this ground alone his complaint must fail.
In a case of medical negligence filed by layman against medical expert, a duty is cast on the layman/complainant to prove medical negligence on the part of O.P./Dr. or hospital by adducing cogent evidence from the expert of the field. Complainant was having cardiac problem. He had approached Cardiologist Dr.Jhala on the suggestion of Dr.Nagvekar. Dr.Jhala had conducted two operations and implanted pace maker in the body of the complainant and when he found that heart was not capturing signals, he had asked the complainant to go for second operation, which he performed successfully. But, even after the second operation, he found that signals were not captured properly and he suggested complainant for going for third operation in Jaslok Hospital for repositioning of PPM. Complainant thought it fit to take advice of another expert. So, he approached Dr.B.K. Goyal, Dean of Bombay Hospital, who also suggested him to do the same thing and complainant then had the third operation done at the hands of Dr.Goyal on 07/07/2001 in Bombay Hospital where PPM was repositioned with the help of 4068 :
Medtronic Capsure Lead and peel away introducer. In the facts and circumstances, we are of the view that whatever operations were done by Dr.Jhala were required to be done and this was confirmed by Dr.Goyal when he conducted third operation on the complainant. The complainant has not adduced any expert opinion from Dr.B.K Goyal to prove that Dr.Jhala had implanted pace maker on the complainant improperly, wrongly without exhibiting requisite skill of Cardiologist of his repute and standing. In the absence of any such expert opinion pointing out the deficiency on the part of Dr.Jhala, relying on the sole affidavit of complainant, we cannot hold Dr.Jhala guilty of medical negligence in the absence of medical expert evidence adduced in that behalf. As against that we are having expert evidence adduced by O.P. Dr.Munsi aged 76 years is a qualified Consultant Cardiologist. He has filed affidavit in support of O.P. In the said affidavit he has clearly stated that protocol followed by Dr.Jhala in treating the complainant in operating complainant and in suggesting him one after another operation was correct.
In the case of Martin F. DSouza V/s. Mohd. Ishfaq, MANU/SC/0225/2009; AIR 2009 SC 2049, the Supreme Court has clearly laid down that whenever complaint is received against doctor or hospital by the Consumer Fora before issuing any notice to the doctor or hospital, it should refer the matter to a competent doctor or committee of doctors, specialized in the field and only on their report of prima-facie case of medical negligence can be made out and notice can be issued to the concerned doctor or hospital. This ratio laid down by the Supreme Court is the latest ratio and this case was filed in 2002. We had issued process against doctor after reading complaint as a whole, but now when we are deciding merit of the case, we cannot overlook the ratio laid down by the Supreme Court in this case. Moreover, in this judgement, Honble Supreme Court clearly made following observations, which is germane to the issue :-
The Courts and Consumer Fora are not experts in medical science, and must not substitute their own views over that of specialists. It is true that the medical profession has to an extent become commercialized and there are many doctors who depart from their Hippocratic Oath for their selfish ends of making money. However, the entire medical fraternity cannot be blamed or branded as lacking in integrity or competence just because of some bad apples.
It must be remembered that sometimes despite their best efforts the treatment of a doctor fails. For instance, sometimes despite the best effort of a surgeon, the patient dies. That does not mean that the doctor or the surgeon must be held to be guilty of medical negligence, unless there is some strong evidence to suggest that he is.
Relying on this ruling of the Supreme Court, we can hold that complainant has failed to prove a charge of medical negligence against Dr.Jhala/O.P. herein and simply because complainant was required to undergo two operations after first one conducted by Dr.Jhala (second one was also conducted by Dr.Jhala and third was conducted by Dr.Goyal), still that does not mean that it is a negligence on the part of Dr.Jhala. Sometimes, one after another operation is required to be carried out in the interest of patient. Doctors duty is to look after the patient as best as he can and if in his judgement, patient requires another operation, he has to first suggest and then conduct another operation to save precious life of the patient. If circumstances warrants, third operation too has to be performed in the best interest of the patient. But, simply because a patient was required to under go one or three surgery that does not ipso-facto prove that there was negligence on the part of first doctor, who conducted first operation or on the part of second doctor who conducted second operation because patient ultimately was required to undergo third operation. So, number of operations does not prove medical negligence on the part of first and second operating surgeon. Here complainant is under wrong notion that simply he was required to undergo second operation at the hands of Dr.Jhala/O.P. herein and third operation at the hands of Dr.Goyal in Bombay Hospital, procedure adopted by Dr.Jhala in first and second operations were wrong, erroneous and not up to the standard or Dr.Jhala was negligent in performing implantation of pace maker in his case.
Complications of implantation, is a Chapter we are finding in Cardiac Pacing and ICDs Fourth Edition book published by Dr.Kenneth A. Ellenbogen and Dr.Mark A. Wood. This book is published by Blackwell Publishing. In this book there is a chapter styled as Complications of Implantation. This book is authority on cardiac pacing and implantation. While dealing with complications of implantation, the authors observed that Inherent with pacemaker therapy is the potential for the occurrence of an untoward event. Skill, experience, and technique are all mitigating factors, but every operator should anticipate that eventually he or she will have to deal with measures to avoid complications but also with their recognition and treatment. Such untoward events associated with the introduction and physical presence of the generator and lead may be classified according to their etiology.
In the Pacemaker Selection in the Elderly (PASE) study, 6.1% of the 407 patients receiving dual chamber pacing systems had a complication of implantation. There were nine lead dislodgements, eight instances of pneumothorax, and four cardiac perforations. A repeat surgical procedure of some sort was required in 18 (4.4%) of the patients. In a single center study of over 1300 permanent pacemaker implants reported by Tobin and colleagues, complications were noted in 4.2% of patients. Lead displacement occurred in
2.4%, significant pneumothorax in 1.5%, pericardial tamponade in 0.2%, and hemothorax leading to death in one patient (0.08%). The economic consequences of a complication were substantial with the average incremental cost of $14,547 for a lead dislodgement; $10,052 for a pneumothorax; and $32,472 for a tamponade. There was an inverse relationship between the incidence of acute implant complications associated with DDD pacing is not different than that with single chamber pacing, the total complication rate associated with dual-chamber pacing over time is higher than that with VVI or single lead VDD due to the presence of the additional lead.
Correction of a lead dislodgement requires surgical intervention to reposition the lead. Before this is done, reasons for dislodgement should be investigated. Careful attention should be directed to the original chest radiograph, and an adequate heel on the intra-cardiac portion of the lead should be sought at the time of lead implantation. Either too little or too much will pre-dispose to dislodgement. One should also review the recorded electrograms from the initial implant looking for a 2 to 3mV current of injury pattern (ST-segment elevation). The absence of this degree of current of injury has been correlated with an increased incidence of lead dislodgement; the implication is that the electrode is not making good endocardial contact. An examination of the anchoring sleeve for adequate fixation should be done at the time of re-operation.
If dislodgement occurs and the reason is not sufficiently apparent that it could be corrected at the second procedure, it would be prudent to remove dislodged lead and replace it with an active fixation lead. This is what has been done by Dr.Goyal in third operation conducted on the complainant. So, there is inherent risk of dislodgement and it is known complication of implantation and therefore, if in such type of implantation, it had crept in as in this case, doctor cannot be blamed for such dislodgement. In the circumstances, we are of the view that complaint is unnecessarily levelling charge of medical negligence against Dr.Jhala who had to our satisfaction rightly treated the complainant. He had done the implantation of pace maker in the complainant properly and he had rightly diagnosed that signals of the heart were not captured and therefore, he had conducted second operation on the complainant and had also advised the third operation rightly though complainant opted to take advice of Dr.Goyal, who also did the same operation. In the circumstances, we are finding that the complainant has failed to prove medical negligence on the part of Dr.Jhala. He had rendered a good professional service to the complainant in the best interest of the complainant and third operation suggested to the complainant was also rightly suggested by Dr.Jhala as is clear from the subsequent events wherein Dr.Goyal performed third operation on complainant for reposition of PPM, the suggestion given by Dr.Jhala. In the circumstances, we are finding that this complaint is devoid of any substance. We therefore record our finding on issue No.1 in the negative and proceed to pass the final order.
-: ORDER :-
1. Complaint stands dismissed.
2. Both the parties are left to bear their own costs.
3. Copies of the order be furnished to the parties free of costs.
(S.P. Lale) (P.N. Kashalkar) Member Presiding Judicial Member dd.