Convenient Hospitals Ltd. and Ors. vs Shankar Lal and Ors.

SMT . Sheela Bhargava (hereinafter referred to as the deceased) was attending to her son, Shri Ram Bhargava, one of the complainants, who was admitted in the Convenient Hospital Ltd. She was suffering from high blood pressure and diabetes. She got herself checked from Dr. Vinod Somani on 11.3.2002, who advised her to be admitted in the hospital as an indoor patient, for undertaking coronary angiography. On the basis of several investigations conducted in the hospital, the ailments of the patient were diagnosed as under: (i) Mild concentric left ventricular hypertrophy;

(ii) Diastolic dysfunction present;

(iii) Good LV systolic function LVEF 60%;

(iv) Hypertensive disease.

The case of the complainants is that the appellant No. 3, Dr. Somani wrongfully noted that the deceased had been referred by another doctor namely, Dr. A. Chaudhary and advised PTCA (Percutaneous Transluminal Coronary Angioplasty) with stent in LAD, and without obtaining consent and without explaining the alternative remedies available to the patient, angioplasty was performed on 14.3.2002. This is also the case of the complainant that the angiography and angioplasty resulted in complications such as Thrombosed Groin Haematoma and false passage in right femoral artery which developed into a pseudoaneurysm, and was later closed on the same date by adopting probe pressure technique. The deceased was discharged on 18.3.2002. The deceased expired on way back to her home in District Sagar in Madhya Pradesh on 21.3.2002. The post -mortem of the deceased revealed that she had multiple subcutaneous hemorrhages in her abdomen, thigh and groin on right side of her body which was a result of leakage from the ruptured blood vessels. Alleging negligence on part of the doctors and the hospital, the complainants claimed refund of Rs. 1,57,214 which they had paid to them, besides Rs. 15,00,000 towards damages.

The complaint was resisted by the respondents inter alia on the grounds that the patient was in a bad health and was in a condition of breathlessness, suffocation, high tension and pain in chest when she was admitted in the hospital for coronary angiography and related checkups. It was admitted in the reply that the patient was recommended PTCA with stent in LAD but it was claimed that the procedure and complications of the operation were explained to the patient and her family members all of whom were influential persons in the locality, and they gave free and unconditional consent to perform the procedure.

In the reply it was also alleged that angioplasty requires use of catheter through a small hole in the thigh groin area and subcutaneous hemorrhages are common and would have healed by appropriate medication that was prescribed to the patient at the time of discharge. It was further claimed that the condition of the patient was stable and her coronary profusal was normal at the time she was discharged. The respondent denied the allegation of the complainants that the clots around the blocked stent were dislodged by heavy doses of anti -coagulants which caused hemorrhages of the thigh groin. The respondents also claimed that they could not be blamed for the stent getting blocked after seven days of the procedure.

It was further claimed in the reply that besides a long standing history of diabetes and hypertension, the patient had classical symptoms of coronary artery disease and the indication of investigation showed that coronary angiography was essential. Coronary angiography showed single vessel disease with 80% blockage of LAD. The treatment of choice for single vessel LAD disease with blockage of more than 80% is angioplasty with stenting, which is considered to be the safest procedure. According to the respondents they had also explained to the family about the recurrence of the angioplasty including the rare possibility of mortality. The respondents also filed a CD whereby the whole process of angiography and angioplasty had been recorded and claimed that the stent was properly fixed and the blockage was removed. It was also claimed that the rest enosis of stent is a known complication not related with the technique of deployment and occurs in more than 10% patients.

VIDE impugned order dated 18.2.2008, the Madhya Pradesh State Consumer Disputes Redressal Commission (for short, the State Commission) held the appellant No. 3, Dr. Somani, to be negligent in treating the deceased and directed the appellants to pay, to the complainants, a sum of Rs. 5,00,000 by way of compensation. Being aggrieved from the order of the State Commission, the hospital and the doctor are before us by way of this appeal. The following are the acts of negligence attributed by the complainants to the appellants: (a) No consent of the patient as per the law was taken before subjecting her to the angiography and angioplasty. The appellants tried to make out a case of valid consent, by introducing the name of one Dr. Chaudhary in the cardiac catheterization report and PTCA report and claiming that the family of the patient had consulted him, before consenting to the procedure, though no such doctor was known to the patient or her family.

(b) The patient was not advised to undergo stress test (TMT)/Thallium Test before subjecting her to angiography and angioplasty though her angina at the time of admission was stable and there was no emergent requirement to carry out angiography followed by angioplasty.

(c) The patient was not informed about the availability of alternative treatments such as management by medicines and diet control, despite angioplasty being a risky procedure at her advanced age. She could have lived comfortably on medicines, coupled with dietary restrictions.

(d) The angiography/angioplasty was performed negligently which led to formation of thrombosis, causing haematoma.

(e) There was negligence in postoperative treatment of the patient as opined by Dr. Gurudatt Tiwari, M.D. Active Coagulating Time and other parameters were not checked on a regular basis, though she was bleeding after removal of the sheath. Anti -platelets aggregation and anti -coagulant drugs were not reduced or removed despite bleeding from the PTCA site. The closure of pseudoaneurysm was unlikely to be closed, within ten minutes, the time indicated in the Doppler Test, by probe pressure technique.

(f) The patient was discharged in a hurry though she had a big haematoma with venous oozing at the time of discharge. She was receiving anti -platelets aggregation and anti -coagulant drugs and, therefore, required hospitalization till active bleeding was stopped. The patient was not advised investigations such as ACT, PT, BT, CT, Hb and Platelets, at the time of discharge, though she was still bleeding at that time.

(g) No attempt was made by the appellants to use medicated stent which would have substantially reduced the possibility of myocardial infarction in the stent.

(h) The massive bleeding under bandages and skin led to the peripheral circulatory failure and hypo -tension, resulting into reduced profusal in coronary artery, causing clot formation at the stent site leading to massive infarction and death.

Consent

THE consent, in the context of the treatment of a patient by a doctor means grant of permission by the patient to the doctor performing a diagnostic surgery or some other procedure, with a view to get the patient rid of his ailment. In United States of America, the Courts insist upon grant of ''informed consent'' by the patient to the doctor, which requires the doctor to inform the patient about the nature and purpose of the procedure or treatment, the expected outcome and the likelihood of success, the risks, the alternatives to the procedure and supporting information regarding those alternatives. He is also expected to inform the patient about the effect of no treatment or procedure, including the effect on the prognosis and the risk associated with no treatment. In United Kingdom, the Courts insist on what is known as ''real consent'', whereby the patient, having requisite capacity and competence, agrees voluntarily to a procedure, without any coercion. The patient must have minimum adequate level of information about the nature of the procedure to which he is consenting. The philosophy behind obtaining an informed consent or real consent is that it is the prerogative of the patient and not the doctor, to determine where his interest lies and which out of the available options he should choose, after evaluating the risks and benefits of all the alternatives available to him. Such a decision on the part of the patient necessarily requires his possessing at least basic understanding of various therapeutic procedures and the risks associated with them.

HOWEVER , the stringent standards laid down by the Court of Appeal in Canterbury v. Spence, 1972 (464) Federal Law Reporter 2d 772, have not been approved by the Hon''ble Supreme Court and it has been held that the standards laid down in Bolam v. Friern Hospital Management Committee,, (1957) 2 All ER 118, popularly known as Bolam''s Test would be appropriate in our social and economic context. The Bolam''s Test was accepted by the Hon''ble Supreme Court in Achutrao Haribhau Khodwa v. State of Maharashtra, : IV (2006) CPJ 8 (SC) : I (1996) CLT 532 (SC) : 1996 (2) SCC 634 as well as in Samira Kohli v. Prabha Manchanda, : II (2008) SLT 25 : I (2008) CPJ 56 (SC) : AIR 2008 (SC) 1385. Noticing that bringing American concepts and standards of treatment procedures and disclosure of risks, consequences and choices will inevitably bring in higher cost structure of American medical care, which the patients in India cannot afford and also noticing that not only people in our country have great regard for doctors, the members of the medical fraternity also have by and large shown care and concern for the patients, the Apex Court felt that to nurture the doctor -patient relationship on the basis of the trust which people in our country continue to repose in their doctors, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam''s Test. The following view taken by the Apex Court in Samira Kohli (supra), is relevant in this regard: "(i) A doctor has to seek and secure the consent of the patient before commencing a ''treatment'' (the term ''treatment'' includes surgery also). The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.

(ii) The ''adequate information'' to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.

(iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.

(iv) There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.

(v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment."

A perusal of the consent form dated 14.3.2002 would show that the patient as well as her daughter -in -law namely Anju Bhargava were explained in detail, the benefits, risks and possible complications of percutaneous transluminal procedure, in their own language. They were also informed that some patients who undergo the procedure may need an emergency surgery. It was also explained to them that there was a possibility of recurrence after angioplasty, etc., on a later date, including a rare possibility of mortality. The consent form further shows that the consent was given for angioplasty/stenting as well as for the angiography. Though the aforesaid consent form is a printed form in which the name of the patient and her attendant as well as the name of the doctor have been filled by hand, there is no material on record to indicate that despite its having been so recorded in the consent form, the benefits, risks and complications mentioned in the consent form were not actually explained to the patient and her daughter -in -law. Smt. Anju Bhargava has not come forward with an allegation that they had signed the printed consent form without the benefits, risks and complications of the procedure having been explained to them in their language. This is also not the case of the complainants that the aforesaid consent form does not bear the signature of the patient and her daughter -in -law. In these circumstances, it will be difficult to say that the benefits, risks and possible complications including the possibility of recurrence after a successful angioplasty and a rare possibility of death were not explained to the patient before she gave consent for angioplasty and angiography. However, the consent obtained by the appellants from the patient, in the presence of her daughter -in -law on 14.3.2002, in our opinion, was defective for the reason that the alternatives to the angioplasty were not explained to the patient. As emphasized by the Hon''ble Supreme Court in Samira Kohli (supra), the doctors should disclose while obtaining consent, inter alia the alternatives if any available to the patient. In the case before us, according to Dr. Gurudatt Tiwari, who is a Doctor in Medicine and whose area of practice includes cardiology, the patient might have lived comfortably on medications and dietary restrictions, for a long time. Even according to Dr. Anil Bharani who deposed in favour of the appellants, there were two options available, either to get PTCA with or without stenting or in the alternative to get coronary artery bypass surgery done, using internal mammary artery (lima) conduit. However, neither the option of surgery nor the option of management with medication and diet control was brought to the knowledge of the patient, as would be evident from the consent form. There is no explanation from the appellants as to why the aforesaid alternative treatments were not explained to the patient before or at the time of taking consent for PTCA and angiography. It appears to us that since Dr. Somani specialized in PTCA alone, he did not inform the patient about the other options available to her, for the control and treatment of her ailment.

Justification for the Procedure

THE next question which comes up for consideration is as to whether angiography and angioplasty of the deceased was justified or not. The contention of the learned Counsel for the complainants was that the deceased had no symptoms of coronary artery disease and Dr. Somani while treating her son, volunteered to check the deceased as well. The case of the appellants on the other hand is that the deceased having complained of breathlessness, etc., she was checked by Dr. Somani on her request and he got the ailment investigated and the Eco -Cardiography and Colour Doppler suggested mild concentric left ventricular hypertrophy as well as diastolic dysfunction and the aforesaid investigation led to angiography and angioplasty being advised to her. A perusal of the cardiac catheterization report of the hospital dated 14.3.2002 would show that the clinical diagnosis of the deceased had revealed diabetes mellitus, unstable angina and essential hypertension whereas the final diagnosis was coronary artery disease with single vessel disease. Though unstable angina was also noted in the aforesaid report, the initial prescription of Dr. Somani dated 11.3.2002 shows the angina of the patient to be stable at that time. Though it cannot be said whether angina of the patient was stable till the time report dated 14.3.2002 was prepared and it was wrongly shown as unstable in the said report or it was stable when the patient was first examined on 11.3.2002 but had later turned unstable. What is more important is that the eco -cardiogram of the deceased clearly indicated that she had a hypertensive heart disease, besides mild concentric left ventricular hypertrophy and diastolic dysfunction. In view of the report of Eco -Cardiogram and Colour Doppler, Dr. Somani, in our view, was not negligent in recommending PTCA with stent in LAD. The investigations such as Eco -Cardiography; Stress Thallium and CT Angiography are not foolproof investigations to detect coronary artery disease and angiography continues to be the gold test for the purpose. Therefore, advising angiography, in a suspected case of CAD, cannot be said to be a negligent act. In a given case, during clinical examination of the patient, a doctor may not find classical symptoms of a Coronary Artery Disease and therefore may advise non -invasive investigations such as TMT, Stress Thallium/Stress Muga or CT Angiography; whereas in another case, he may find sufficient indications of such a disease. In the earlier case, the tests such as TMT, Stress Thallium, etc., may not be felt necessary and the patient may be straightway subjected to an angiography.

THERE is no material before us which would show that advising angiography and angioplasty when blockage was confirmed during angiography was not the appropriate treatment for a 67 years old woman suffering from coronary artery disease with single vessel disease. The learned Counsel for the complainants contended before us that instead of advising angiography and angioplasty, the patient should have been treated with conservative treatment comprising medicines, diet control and change of life style. But, there is no material before us which would show that angioplasty should not have been recommended to a patient who had 80% blockage of the LAD. The next question which comes up for our consideration is as to whether any negligence was committed by Dr. Somani in advising angiography/angioplasty of the deceased.

THE learned Counsel for the complainants placed reliance on the deposition of Dr. Anil Bharani who headed the penal of doctors which gave the report dated 28.4.2004 exonerating Dr. Somani as well as opinion of Dr. Gurudatt Tiwari, a witness examined by the complainants, to show that the patient had a stable angina. However, there is no medical literature before us which would show that advising angiography/angioplasty to a patient with 80% blockage of LAD would not be a prudent advice when the patient does not have an unstable angina. It is quite possible that a patient of coronary artery disease may manage either for a limited period or throughout his life with conservative treatment, but it is also equally possible that he may have a sudden blockage of artery leading to a massive heart attack and may not survive. Therefore, it cannot be said that no patient should be advised angiography/angioplasty if he does not have an unstable angina and there is no urgency requiring such a procedure. In fact, a large number of persons undergo angiography and angioplasty if required, when their angina is stable and not in an emergency since the procedure may not yield positive results if performed in an emergent condition when the patient all of a sudden suffers a heart attack on account of blockage of the artery. Also, the preferred choice of treatment in such cases varies from doctor to doctor. One doctor may like to take some risk with the life of the patient and treat him with conventional treatments such as medicines, change in life style and diet restrictions; whereas another doctor may emphasis more on the quality of life a person suffering from a heart ailment leads and may advise him to get the blockage of the artery removed so that he may thereafter lead a normal life without always being apprehensive of a possible heart attack on account of blockage which he carries in his coronary artery. The following view taken by the Hon''ble Apex Court in Achutrao (supra), is relevant in this regard. "The nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession, and the Court finds that he has attended on the patient with due care, skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence."

In Samira Kohli (supra), the evidence before the Court demonstrated that there was more than one way of treating Endometriosis, the ailment from which the patient was suffering. While one view favored conservative treatment with hysterectomy as a last resort the other favored hysterectomy as a complete and immediate cure. It was held that the respondent doctor could not be negligent merely because she chose to perform radical surgery in preference to conservative treatment. Therefore, it would be difficult to say that a doctor advising angioplasty to a patient having 80% blockage in an artery is guilty of negligence in performance of his duties as a doctor.

A perusal of the impugned order would show that the State Commission noted three complications from the procedure undertaken by Dr. Somani, the same being (i) pseudoaneurysms, (ii) severe haemorrhage (bleeding from PTC A site) and (iii) Haematoma at the groin which grew quite large (8 c.m. x 8 c.m.). Treatment during Hospitalisation

A haematoma is a localized collection of blood outside the blood vessels, usually in liquid form, within the tissue. In the medical literature it is defined as a space occupying collection of blood initially localized adjacent to the vessel and ultimately spreading into the surrounding tissues. Some haematomas are associated with underlying pseudoaneurysms. The medical literature defines pseudoaneurysm as a haematoma that remains in continuity with the arterial puncture site, allowing flow in and out of the haematoma during systole and diastole. It can be differentiated from the simple haematoma by the presence of bruit and palpable pulsatile mass. It is described as below in the medical literature: "A pseudoaneurysm is an encapsulated hematoma which communicates with an artery because of incomplete sealing of the media. The principle causes of pseudoaneurysm are inadequate compression following sheath removal and impaired hemostasis. Low vascular access in the superficial or profunda femoral artery increases the likelihood of pseudoaneurysm, since their deep location is less amenable to compression."

As per medical literature provided by the appellants (medical and peripheral complications, Chapter 25), factors associated with bleeding complications include female gender, low body weight, advanced age, urgent procedure, low base line haemoglobin, long procedure duration, larger sheath size, increase heparin dose, thrombolytic agents and multivessel disease. The key to avoid bleeding complications is stated to be meticulous attention to the access site, recognition of predisposing factors and avoidance of post procedural heparin. The skin neck should be larger than the sheath diameter, to facilitate external expression of blood loss.

THE management of haematoma involves stabilization of hemodynamic status and control of hemorrhage on priority basis. The access site should be treated by direct manual compression, pneumatic compression or mechanical clamp. If large haematoma is present, manual compression can help dissipate blood in surrounding tissues and soften the area which may facilitate compression and resolution of haematoma. If bleeding cannot be controlled, urgent surgical exploration may be required.

THE factors which increase the risk of Pseudo aneurysm include severe peripheral vascular disease, large sheath, prolonged sheath time, prolonged anti -coagulation, impaired platelet function and premature ambulation. The treatment of pseudoaneurysm depends on its size, expansion and the need for anti -coagulation. The management of pseudoaneurysm may also require compression or surgical repair. Pseudoaneurysm less than 3 c.m. can often be managed clinically. The follow up ultrasound 1 -2 weeks after initial diagnosis often administers spontaneous thrombosis and obviates the need for repair. However, the spontaneous thrombosis is less likely when the pseudoaneurysm is more than 3 c.m. on initial ultrasound evaluation. Ultrasound guided compression is said to be effective for closing pseudoaneurysm, but requires that the pseudoaneurysm be rightly visualized. Those receiving anti -coagulation have success rate of 54 to 86 percent when treated by ultrasound guided compression. The factors which increase the likelihood of a vascular complication during cardiac catheterization include larger sheath size, increased time duration of sheath in place of low arterial puncture below common femoral bifurcation. The treatment options for pseudoaneurysm are stated to be: (i) Surgery,

(ii) Ultrasound guided compression,

(iii) Direct thrombin injection,

(iv) Observation,

(v) Endovascular placement of a covered stent.

IN the case before us, admittedly, the patient had haematoma coupled with pseudoaneurysm. On 15.3.2004, Dr. Somani had observed, "A partly thrombosed groin haematoma which harboured the pseudoaneurysm measuring 1.9 x 1.8 c.m. with long neck of 1.5 c.m. and high PSV of about 80 c.m". The radiologist employed USG guided probe pressure technique with pressure targets on the neck of the pseudoaneurysm and reported that the procedure had resulted in closure and thrombosis of the pseudoaneurysm. After the procedure, common femoral vessels were found to be normal. However, the appellant, Dr. Somani has not told us as to what in his opinion was the cause of the patient developing haematoma coupled with pseudoaneurysm. This can hardly be disputed that the haematoma coupled with pseudoaneurysm occurred due to bleeding from the artery/vein of the patient. There is no explanation from Dr. Somani as to why the artery/vein of the patient started leaking after the PTCA procedure. This, probably could be due to inadequate and/or improper sealing after the puncture of the artery in the groin area or on account of puncture being larger than required. It could also be on account of size of the sheath used by the doctor being inappropriate. Yet another reason could be failure to apply adequate pressure at the puncture site, after the procedure had been finished. Of course, there could be reasons other than those stated above, but what is important is that Dr. Somani has not been forthcoming as regards the cause of bleeding which led to the formation of haematoma coupled with pseudoaneurysm. The contention of the learned Counsel for the complainant was that haematoma and pseudoaneurysm took place either on account of the size of the sheath being larger or the sheath having been allowed to remain for duration longer than it ought to have been allowed or because of low arterial puncture. According to the learned Counsel all the three reasons referred above are attributable to the negligence of the doctor. However, considering that we have no clear medical opinion as to what caused haematoma coupled with pseudoaneurysm and the reasons for haematoma and/or pseudoaneurysm could also be other than the three reasons stated above, we are not inclined to hold the appellant -doctor negligent in the treatment of the patient only on account of her having developed haematoma and pseudoaneurysm.

THOUGH as per the report of Dr. Ravi Masand, Radiologist, he had applied pressure using USG guided probe pressure technique for about 20 minutes, the time duration indicated by the Doppler test is only 10 minutes. In the opinion of Dr. Tiwari, the pseudoaneursym of the size 1.9 x 1.8 c.m. was not likely with pressure of about 10 minutes. However, considering that the radiologist, in his report dated 15.3.2002 clearly stated that he had applied pressure for 20 minutes and the procedure had resulted in closure and thrombosis of pseudoaneurysm, we are not inclined to hold the appellants negligent in the treatment of the patient, in the management of pseudoaneurysm by using USG guided probe pressure technique. It was contended by the learned Counsel for the complainants that instead of treating the haematoma and pseudoaneurysm himself or calling a radiologist to apply USG guided probe pressure technique, the appellants ought to have called a vascular surgeon who would have been best suitable to treat such complications. This can hardly be disputed that a vascular surgeon would be better trained for management of vascular diseases such as haematoma and/or pseudoaneurysm, but considering that ultrasound guided compression was the most appropriate initial treatment for closure of pseudoaneurysm and as per the medical literature, surgical repair is explored only if the pseudoaneurysm persists beyond two weeks or expands, we are not inclined to held the appellants negligent on account of their having not asked for a vascular surgeon to treat the patient. What is important in this regard is the treatment given to the patient. If the radiologist has given the same treatment which the vascular surgeon would have given, and the deficiency in the treatment is shown, there will be no negligence which can be imputed to the treating doctor.

WE , however, find that there was some negligence in treatment of the patient, during her hospitalization. It is an admitted position that Activity Coagulation Time and other parameters were checked only pre and post angioplasty. The said parameters were not checked later, on a regular basis though the patient was bleeding from the sheath site. The continuous bleeding was evident from the haematoma and pseudoaneurysm which the patient had developed. Though it is stated in the report of the radiologist that post USG guided probe pressure technique, the pseudoaneurysm had closed, the fact that the haemoglobin of the patient did not show much improvement thereafter and the doctor had got four units of blood arranged for transfusion is a clear indicator that even post -employment of USG guided probe pressure technique, there was further leakage from the PTA site in the groin of the patient. The haemoglobin of the patient had not come near the normal level even by the time she was discharged. She had oozing from the venous sheath even at the time she was discharged. In these circumstances, it was necessary to check the aforesaid parameters on a regular basis by advising investigations such as Activity Coagulation Time (ACT), Pro -Thrombodin Time (PT), Bleeding Time (BT), Clotting Time (CT), Haemoglobin level and platelet count. This was more so when admittedly the patient continued on anticoagulation medicines even in the face of bleeding from the PTA site in her groin. Had the aforesaid parameters been checked on a regular basis that would certainly have helped in adjusting the dose of anti -coagulation drugs. Based upon the reports of the aforesaid investigations the doctor might have either reduced or even temporarily stopped the anticoagulation and anti -platelet medicines. Therefore, in our considered view Dr. Somani committed negligence in treatment of the patient by not checking her anti -coagulation time and other parameters on a regular basis, during the period she remained in the hospital. Discharge:

A perusal of the discharge summary of the patient clearly shows that at the time she was discharged on 18.3.2002 she had a big haematoma due to oozing from venous sheath. The bleeding from the sheath site, therefore, had not completely stopped by the time she was discharged. Despite that, the patient was discharged from the hospital instead of keeping her admitted and giving appropriate treatment for stopping the oozing of blood from the sheath site. It can hardly be disputed that management of bleeding in the hospital would be much more effective than managing at home. Once the patient is discharged, neither the doctors are available at home nor can the requisite investigations be carried out at odd hours. In case transfusion of the blood is required, that also is not possible at the residence of the patient. More importantly, the patient may not even notice that the bleeding continues to persist, post her discharge from the hospital and, therefore, may not even visit a doctor or a hospital unless she is in a severe pain or discomfort. Therefore, in our opinion, Dr. Somani committed negligence in the treatment of the patient by discharging her on 18.3.2002 despite the fact that blood was still oozing from venous sheath at the time of her discharge. Moreover, even while discharging the patient, Dr. Somani did not advise her the investigations such as ACT, PT, BT, CT, Hb and platelet count, despite her haemoglobin level being low and oozing continuing from the venous sheath. In fact, it was wrongly recorded in the discharge summary that post cath period was uneventful. Considering that the patient had haematoma coupled with pseudoaneurysm on account of bleeding from the PTA site in the groin, it would not be correct to say that her stay in the hospital, post -angioplasty was uneventful. Had Dr. Somani advised the patient to get her ACT and other parameters checked on a regular basis, abnormal report in the aforesaid tests would have alerted the patient and/or her family members and they would have taken her to the doctor/hospital for further evaluation and treatment, instead of continuing with the medicines which were prescribed to her at the time she was discharged from the hospital. As rightly pointed out by Dr. Tiwari, the discharge of the patient from the hospital on 18.3.2002 was a matter of further concern considering that she was receiving anti -platelet aggregation and anti -coagulant drugs and her bleeding had not stopped. Medicated Stent

According to the complainants, Dr. Somani was guilty of gross negligence in not using a medicated stent despite advanced age of the patient and the possibility of the blockage of the stent being much less in case medicated stent is used. We, however, find that there is no evidence to show that medicated stents were being regularly used in India at the time angioplasty was performed. It has come in the deposition of Dr. Anil Bharani, Professor of Medicine and Head of Cardiology in MGM Medical College and MY Hospital, Indore that though medicated stent is preferred these days, the said stents were still in the age of evolution in the year 2002. Even in USA the use of medicated stents was approved by US Food and Drug Administration (FDA), in April 2003. Therefore, though the medicated stents decrease the chance of restenosis, since such stents were not being used at the relevant time no negligence to Dr. Somani can be attributed on account of his having not used the said stents. Cause of death

IN the opinion of Dr. G.D. Tiwari, the massive bleeding under the bandages and skin led to peripheral circulatory failure and hypotension, resulting into reduced perfusal in coronary arteries and that caused clot formation at the stent site, leading to massive infarction and death. On the other hand, the team of doctors from MGM Medical College and MY Hospital, Indore, based on clinical circumstances and published literature, speculated cause of her death to be sub -acute in stent thrombosis leading to occultation of the stented artery and subsequent myocardial infarction causing her death. They also stated that stent thrombosis is a known complication of PTCA/stenting prevalence being 1%, which occurs within one month of the interventional procedure. This occurs more commonly when a non -coated or bare metal stent is used compared to use of drug coated or drug eluded stent. A perusal of the medical literature submitted by the appellants also shows that though compared to surgical intervention balloon angioplasty is a relatively low risk procedure, abrupt vessel closure marked by blockage in the area treated by the balloon angioplasty is a main potential risk with the aforesaid procedure. The literature further shows that although reduced by aggressive anti -coagulation, sub -acute thrombosis continue to occur in 4 to 5 percent of patients, following elective stent placement. The rate of abrupt closure or stent thrombosis has been in the range of 1%. In fact, an analysis of six coronary stent trials indicated that 18.9% of patients who had experienced acute stent thrombosis died within 30 days. In our opinion, the complainants have not been able to establish that the acute myocardial infarction which led to the death of the patient was attributable directly to the deficiency/negligence in the treatment of the patient. The complainant has not produced any medical literature which would convince us that thrombosis of the stent was on account of the bleeding which the patient was having during hospitalization as well as at the time she was discharged from the hospital. In our view, though there were deficiencies and negligence in the treatment of the patient, her death cannot be attributed to the said negligence/deficiencies.

FOR the reasons stated hereinabove, we conclude that though the appellant, Dr. Somani was negligent in treatment of the patient, to the extent stated hereinabove the complainants have failed to establish that the death of the patient occurred due to aforesaid acts and negligence on his part. Consequently, the complainants are entitled to compensation commensurate with the acts of negligence which they have been able to establish. In the facts and circumstances of the case, while maintaining the direction of the State Commission for refund of the treatment charges of Rs. 1,57,214 by the appellants we award a lump sum compensation of Rs. 2,00,000 to them. Thus, the appellants will refund the cost of treatment amounting to Rs. 1,57,214 and shall also pay compensation amounting to Rs. 2,00,000 to the complainants. The complainants shall also be entitled to cost of litigation quantified by the State Commission at Rs. 5,000. Vide order dated 7.4.2008 the appellants were directed to deposit a sum of Rs. 2,50,000 with the State Commission and the said amount was directed to be kept in a fixed deposit. The State Commission is directed to release the amount kept in the FDR along with interest which has accrued on it, to the complainants within four weeks of receiving a copy of this order. The balance amount shall be paid by the appellants to the complainants within four weeks from today. The Appeal is disposed of with the above directions.