State Consumer Disputes Redressal Commission
Sukhwinder Kaur vs 1. The Escorts Heart Institute And ... on 13 February, 2009
At the outset it may be mentioned that the counsel for the complainant has referred to and relied upon large bunch of document IN THE STATE COMMISSION: DELHI (Constituted under Section-9 Clause (b) of the Consumer Protection Act, 1986) Date of Decision: 13-02-2009 Complaint Case No. C-22/2004 Smt. Sukhwinder Kaur, (Widow of Late Sh. Mehar Singh), R/o H.No.871, Dwarikapuri, Jagadhari, Distt. Yamuna Nagar (Haryana) .. Complainant Versus 1. The Escorts Heart Institute and Research Centre, Okhla Road, New Delhi-110025. 2. The Executive Director, The Escorts Heart Institute and Research Centre, Okhla Road, New Delhi-110025. 3. Dr. T.S. Kler, MD,DM,MRCP( U.K.) Chief of the Cardiac Electro Physiology and pacing Escorts Heart Institute and Research Centre, Okhla Road, New Delhi-110025 4. M/s Medika Eletronik Services, 101, Ist Floor, Local Shopping Complex Gupta Plaza, Plot No.13, Kalkaji New Delhi-110019. . Opposite Parties CORAM JUSTICE J.D. KAPOOR, PRESIDENT MS. RUMNITA MITTAL, MEMBER
1. Whether Reporters of local newspapers be allowed to see the judgment?
2. To be referred to the Reporter or not?
JUSTICE J.D. KAPOOR (ORAL)
1. The allegations in the present complaint alleging medical negligence are that a new Pacemaker was implanted in the heart of the deceased Mehar Singh by Opposite Party (in short O.P) Dr. Kler which did not function properly and ultimately the patient Mehar Singh died. According to the complainant, this new device was not approved by the Govt. or any other authority and was used by the doctor as on experiment which cost the patient his life. This device was supplied by OP-4 at the cost of Rs. 8.5. Lacs. Op-1 even illegally retained this device after the death of the patient in OP-1 hospital. Complainant is seeking the following reliefs:-
a) Refund of Rs.1,71,600/- paid by the complainant to OP-1 for treatment of the deceased.
b) Rs. 8.5 Lacs on account of the price of the pacemaker.
c) Rs.61,71,600/-
on account of compensation.
2. Briefly stated the facts as alleged by the complainant are that Late Mehar Singh was admitted in the OP-1 hospital with a heart ailment under care and treatment of OP-3, Dr. Kler on 10.04.2002. After carrying out expensive investigations costing a total of Rs.1,56,300, Dr. Kler implanted a new kind of pacemaker known as combo device, which was supplied by OP-4 at a cost of Rs.8,50,000/-, on 27.04.2002, and the patient was discharged on 01.05.2002. However, the patient did not get any relief from this implant as he had the feeling of restlessness and breathlessness and he was again admitted in the OP-1 hospital on 15.06.2002 for cardio version. After the procedure his condition even worsened but Dr. Kler discharged him hurriedly on the same day. He was again admitted in the OP-1 hospital on 08.08.2002 where he died on 10.08.2002. The death certificate issued by the hospital described the cause of death as follows:-
Immediate cause of death: Carcinogenic shock.
Antecedent causes of death:
Dilated cardiomyopathy Acute L.V.F. Left Ventricular Failure) ARF (Acute Artrial Fibrillation)
3. According to the complainant death occurred due to the non-functioning of the pacemaker. It is further stated that the family members of the patient were never explained the benefit and effect of the new kind of the pacemaker by the doctor. Another grievance of the complainant is that OP-1 has illegally retained the pacemaker in question costing Rs.8.5. lacs. It is further stated that the new combo device implanted by the doctor was used for the first time in India as an experiment which experiment failed and cost the deceased his life. This device was not even legally approved by the Govt. of India or any other authority. It is further stated that the medical treatment decided, prescribed and given by Dr. Kler was not proper and correct. Moreover the negligence was compounded by not checking the leads of the device on 15-06-2000 when the patient was again admitted.
4. OPs have denied all the allegations including the allegations of medical negligence. It is stated that the patient was an old heart patient since 1994 and he had a pacemaker, Single chamber, implanted as far back as 1997 at G.B. Pant Hospital. He was admitted to OP-1 hospital with a history of severe breathlessness on exertion for 55 years, breathlessness on lying down and episodes of breathlessness at night for three months. Coronary angiography procedure was performed on him on 16.04.2002 at the OP hospital. The patient was having atrial fibrillation for which he was DC cardioverted on 23.04.2002 under deep anesthesia and the irregular rhythm of the heart was changed to regular rhythm. On 27.04.2002 ICD. Combo ICD + Biventricular Pacemaker) implantation was done by OP-3 Dr. Kler and the patient was discharged on 01.05.2002 in a stable condition. Subsequently, patient was admitted on 15.06.2002 with the complaint of breathlessness at rest and lack of steep for 2-3 days. Cardio version was done on the same day with 300 J and 360 J, which was unsuccessful. It is stated that cardio version is not always successful. The patient was prescribed medication and was discharged on the same day. He was again admitted on 08.08,2002 with the complaints of breathlessness, decreased urinary output and oedema in the lower limbs. He was having left ventricular failure and also atrial fibrillation. He was cardioverted the same day and was also put on medication. On 09.08.2002, the patient had severe breathlessness and urine output further decreased almost to zilch. He was put on mechanical ventilator and drugs to increase the blood pressure. On 10.08.2002 at 10.30 p.m. the patient had a fall in blood pressure and cardio-pulmonary resuscitation was started but the patient could not be revived. Poor prognosis was explained to the attendants of the patient. It is stated that implantation of the device was essential.
5. It is admitted that the combo device used was a new kind of device, which was a combination of two already known devices. Combo device was already well known abroad and a number of successful procedures had been successfully performed there. This was legally approved by the European Agency, TUV as far back as on 13.10.1999 vide a certificate, which was valid till 2007. It is admitted that this was the first combo device implanted in India. It is further stated that the effect and benefit of the device was explained to the attendants of the patient and the patient gave the informed consent for implanting this device. It is denied that the device did not function properly. The patient died due to progressive heart failure, which is not unexpected considering his medical history.
6. As to the non-return of the device to the complainant, it is stated that such a device is always taken out of the body after the death of the patient as it explodes in fire and the same was done in the case of the deceased Mehar Singh. Relatives of the deceased willingly gave the device to Dr. Kler (though the consent was verbal) who told them that this device could be used in another patient who could not afford such an expensive device. It is further stated that this device was implanted on 16.11.2002 in Major Sohan Singh Sandhu(Retd.) free of charge and that the same is still working till today.
7. OP-1 to 3 have also stated that the Delhi Medical Council investigated the allegations made against them by the complainant and concluded vide order dated 22.07.2004 that the decision to implant the device was correct in contemporary medical practice and the patient died of progressive heart failure, which is not unexpected considering the natural history of this disease. There is no medical negligence in the treatment administered by Dr. T.S. Kler. According to OP-4 the device in question was legally approved by the European Agency TUV vide a certificate, which was valid till, 2007.
8. Complainant has filed a rejoinder reiterating the averments made in the complaint. It is stated that the conclusion drawn by the Delhi Medical Council is not correct. As to the consent, it is stated that consent was given for ICD device and not for combo device. As to the return of the device it is stated that the same was not returned despite demands by the complainant.
9. Parties have filed their evidence by way of affidavits which are on record.
10. At the outset it may be mentioned that the counsel for the complainant has referred to and relied upon large bunch of documents produced by the OP-Hospital with regard to the admission of the patient, various tests carried out on him before implantation of the ICD etc. to show the negligence in respect of agreeing to the patient apart from giving AICD and wrong informed consent. These are as under:-
(i) Annexure-I is the reference of the patient to the Escorts Hospital observing that Ejection Fraction (E.F.). 20% whereas normal E.F. is 60% to 100% which means the E.F. was so low that the pace maker could not have worked and it further shows that the patient was suffering from not only ventricular arthmias but also from artrial fibrillation and therefore the OP decided to control both the problems and therefore they conducted an experiment with this new device for the first time in India but failed in the said experiment.
(ii) The patient was admitted on 10-04-2002 and it was after 17 days that the pace maker was implanted on 27-04-2002 and the Informed Consent produced by the OP is dated 26-04-2002 (Annexure R-V) which shows the therapeutic procedure of ICD implantation was to be done and there was no mention in this informed consent that a new kind of AICD which was introduced first time in India was implanted in the patient and therefore such a consent is not valid nor a well informed consent.
(iii) The patient was discharged on 01-05-2002 but he did not get any relief as he had been feeling restlessness and breathlessness and again admitted on 15-06-2002 for Cardio version and the cardio version was done at about 4.30 P.M. Thus the patient remained without any medical attention and the attempted cardio version was unsuccessful and this shows that one of the two cardio version was helping the patient and still the OP-Hospital discharged the patient in spite of being in bad condition. He was discharged on wheel chair on the same day though he was not fit for discharge.
This again shows that after operation the doctor was negligent in not properly looking after the patient .
(iv) Annexure Ex. 10, the Discharge Summary shows that the cardio version done on 15-06-2002 which showed that the cardioversion attempted with 300J and 360J was unsuccessful which means that the device was not functioning properly and the patient was not getting requisite yield with the device.
(v) Moreover the AICD device of model 7272 was not approved by the Government of India or any other authority and still the doctor was experimenting with it without ascertaining whether this particular device would work properly or function properly or would yield desired result on a particular patient or not.
(vi) The version of the OP that the complainant donated the pace maker which was taken out before cremation of the deceased so that it would not explode is false, as such a device of very high value could not have been donated for being implanted to those persons who were not in a position to afford the said device, as subsequently the same was implanted in the body of one Army Major who is a person who could not have been admitted in the free category. In this regard legal notice was also sent to the OP for returning the same and also for compensation but no reply was given by the OP and they denied the allegation and threatened with dire consequences.
(vii) So much so the OP gave advertisement in the newspapers and also in the TV claiming that AICD device had been planted by Dr. Kler in a patient which was functioning properly whereas the fact remains that the discharge summary prepared by the OP-Hospital itself showed that it was not functioning properly as on 15-06-2002 and the cardiac version could not succeed and therefore the patient was admitted again and again with the same problem and after about 4 months or so he died. This advertisement was published in the Indian Express on 4th May 2002
(viii) As per Conduct Rule of Medical Council of India, rule 6 Chapter 6 Unethical Acts a physician shall not aid or abet or commit any of the following acts which shall be constructed as unethical:-
6.1.
Advertising Soliciting of patients directly or indirectly, by a physician by a group of physicians or by institutions or organizations is unethical. A physician shall not make use of him/her (or his/her name) as subject of any form or manner of advertising or publicly through any mode either alone or in conjunction with others which is of such a character as to invite attention to him or to his professional position, skill, qualification, achievements, attainments, specialities, appointments, associations, affiliations or honours and/or of such character as would ordinarily result in his self aggrandizement. A physician shall not give to any person, whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report or statement with respect of any drug, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or appliance or any test, demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through any mode. A medical practitioner is however, permitted to make a form an announcement in press regarding the following:-
(i) On starting practice.
(ii) On change of type of practice.
(iii) On changing address.
(iv) On temporary absence from duty.
(v) On resumption of another practice.
(vi) On succeeding to another practice.
(vii) Public declaration of charges.
(ix) The enquiry that was conducted by Medical Council which was done on the back of the complainant which on the face of it is a bias report as it has not taken care of the conditions of patient, whether such device is advisable or not advisable or not but has made a general observation that it was correct in medical practice.
11. We have accorded careful consideration to the rival claims and contentions of the parties and heard the Ld. Counsel for the parties at length. There are mainly two points of contention calling for determination in this case. First is whether the decision of the OP doctor to implant the ICD device in the patient was correct or not particularly when the ejection fraction was found to be 20% which was so low, whereas the normal rate is 60-100%, that the pace maker could not work. Second is whether the ICD device was donated by the complainant or after the death of the patient it was taken out from body to be implanted in another poor patient or whether the hospital has used the said device for ulterior purpose by taking the cost of the device from another patient.
12. As regards the first question we do not find any material or literature on record that the decision of the OP doctor was wrong or he with malafide intention used the device on the deceased patient just as an experiment or treating him as a guinea pig.
13. In this regard we have the expert opinion of the Delhi Medical Council which has completely absolved the OP doctor with the specific observation that the decision to implant the device was correct and as per contemporary medical practice and for the patients benefit. Further after the death of the patient the device was rightly removed to avoid explosion hazard during cremation. It was further observed that as regards the functioning of ICD component of the device is concerned it is meant to treat only ventricular arrhythmias. It does not treat artrial fibrillation. Thus, extreme cardioversion for artrial fibrillation does not imply failure of the device.
14. The Council has also opined that the patient died of progressive heart failure which is not unexpected considering the natural history of this disease and there is no medical negligence in the treatment administered by Dr. T.S. Kler.
15. It has categorically absolved the doctor from the charge of medical negligence in the treatment or for not obtaining the consent of the next of kin of the deceased prior to removing and implanting the device into another patient.
16. Similarly, the charge of not checking the leads on 15-06-2002 also does not amount to any negligence. Had the decision of the doctor been patently wrong or had he the intention to use the device as an experiment on the patient the patient would not have survived for 4-6 months. Because his ejection fraction was 20% against the normal 60-100%, he would have died instantly or within a week or so. But he survived for about 6 months and then died may be due to physical metabolism or some other reasons as has been observed by the Medical Council, i.e. progressive heart failure.
17. We cannot be oblivious to the fact that another patient on whom this device was implanted survived for pretty long time and it is stated that he is still surviving and the affidavit of the said patient shows that nothing was charged from him as to the cost of the device and therefore the version of the OP that the next of the kin of the patient had donated this device for being implanted into another needy patient inspires confidence as in such eventuality, the kin of the deceased think in terms of charity or generosity, that why not the device be used on a needy or poor patient, who may survive because of this device and lead a normal life.
18. However, taking over all view of the matter and also being conscious of the sentiments of the complainant who lost her husband inspite of having purchased the device costing Rs. 8.00 Lacs, we on compassionate and humanitarian grounds direct the OP hospital to refund at least Rs. 2.5 Lacs to the complainant as an altruistic gesture and also on the premise that he was the first patient on whom the OP doctor had implanted this device which could not yield the desired result, may be, for any reason whatsoever, without any adverse observations against the conduct of the doctor or against his medical expertise or knowledge or skill as there was no kind of negligence either in the treatment or implanting nor was there any malafide in taking out the device for being used for earning money by hoodwinking or taking advantage of the complainant being a gullible person or village folk as it would have been of no use to them and could be used on some other patient and the hospital has not charged anything from the patient. There is nothing on record to show that the other patient was charged for the implant nor do we have any reason to disbelieve the bonafide of the doctor or the hospital.
19. In result we allow the complaint and direct the OP-1 to pay Rs. 2.5 Lacs as lump sum compensation for the mental agony or emotional suffering suffered by the complainant. Payment shall be made within one month from the date of receipt of a copy of this Order.
20. Complaint stands disposed of in aforesaid terms.
21. Copy of Order, as per statutory requirement be forwarded to the parties and to the concerned District Forum and thereafter the file be consigned to record.
(JUSTICE J.D. KAPOOR) PRESIDENT (RUMNITA MITTAL) MEMBER HK