Chandigarh

StateCommission

CC/508/2017

Sohan Lal Bansal - Complainant(s)

Versus

Government Medical College and Hospital - Opp.Party(s)

Harsh Garg, Adv.

11 Jul 2018

ORDER

STATE CONSUMER DISPUTES REDRESSAL COMMISSION,

U.T., CHANDIGARH

 

Complaint case No.	:	508 of 2017
Date of Institution	:	29.06.2017
Date of Decision	:	11.07.2018

 

Sohan Lal Bansal s/o Sh. Chhajju Ram Bansal, r/o # 2, Opposite 70-B, Model Town, Patiala, Disttt. Patiala.

 

……Complainant

V e r s u s

1. Government Medical College and Hospital, Sector 32, Chandigarh through its Director Principal.
2. Dr. Srinivasan Reddy, Professor, Department of Cardiology, Government Medical College & Hospital, Sector 32, Chandigarh.   

                                                    .... Opposite Parties                      

BEFORE:         JUSTICE JASBIR SINGH (RETD.), PRESIDENT

                        MR. DEV RAJ, MEMBER.

                        MRS. PADMA PANDEY, MEMBER

 

Argued by:      

 

Sh. Rakesh Gupta, Advocate for the complainant.

Sh. Manu Kakkar, District Attorney for Opposite Party No.1.

Sh. Rajeev Kawatra, Advocate for Opposite Party No.2.

 

PER PADMA PANDEY, MEMBER

 

              The facts, in brief, are that wife of the complainant, namely, Smt.Baby Rani Bansal was having a minor problem in breathing. She got the normal ECG as well as blood tests done on 06.07.2016 at private clinic at Patiala, where there were some changes in ECG and other tests relating to heart were normal. Therefore, the complainant visited Dr.Manohan Singh at Patiala on 07.07.2016 and after giving the preliminary treatment, the complainant’s wife was advised angiography. The complainant got second opinion from Dr.Sudhir Verma of Sadbhawna Medical and Heart Institute and advised the complainant’s wife to get the angiography done few days after her heart becomes stable. Copies of the treatment advised by both the doctors are Annexures C-2 and C-3. Thereafter, the complainant visited the hospital of the Opposite Party on 13.07.2016 and she was attended by Dr.Srinivasan Reddy, Professor of Cardiology, who advised her angiography and asked to come on 14.07.2016. On that date i.e. 14.07.2016 she was taken for angiography. The complainant’s wife walked to the cath lab/OT table for angiography being absolutely normal. On 14.07.2016 the angiography was done by Dr.Reddy and during angiography, the complainant was called inside the OT and told that there is stenosis (blockade) in three vessels to the extent of 70%, 80% and 95%. It was further stated that when the complainant requested Dr.Reddy to go for bye pass surgery when the said doctor told that bye pass surgery is a thing of the past and lot of innovations have come in the treatment of blocked arteries under the medical sciences. He strongly recommended to get stenting and told the complainant that there is half an hour procedure of stenting and his wife will be discharged on 15.07.2016. Believing the advice of Dr.Reddy, the complainant gave his consent for putting stents. After about 15 to 20 minutes, the complainant saw certain abnormal commotion in the operation theatre and could see the panic on the faces of the staff of the OT. The complainant was called insifde the operation theatre by Dr.Reddy and he was told that his wife is serious as there is water in her lungs and the tube had been inserted.  The complainant saw that OT staff was pressing the chest of his wife, which is normally done when the heart of a patient stops working. On seeking the seriousness of the patient, the complainant requested Dr.Reddy to refer to the patient to PGI or any other hospital, in case, they are unable to handle the case but Dr.Reddy said that there is no use, at this stage, as his wife expired on table during procedure, whereas, on the paper, she was declared dead at 4.30 PM. It was further stated that the complainant applied under RTI and got the necessary coronary angiography report prepared by Opposite Party No.2 on 14.07.2016 (Annexure C-4). As per the said report mid left anterior descending (LAD) artery was having 80% stenosis with myocardiac bridge and angulation, whereas, the distal LAD was normal, while left circumflex (LCX)-OM-1 was having 95% stenosis while distal LCX had 70% stenosis. As per the information given by the hospital, the patient died during the procedure. Copy of death summary report is Annexure C-5. It was further stated that there was thrombotic occlusion of OM-1. It was further stated that OM-1 which was one of the major artery was having 95% blockade and had thrombotic occlusion and in this regard, only course of action advisable for any cardiologist was to first secure the culprit vessel i.e. OM-1 but to the contrary, Opposite Party No.2 first opened LAD, which only had 80% stenosis and because of the complication in that procedure, the blood supply to the heart and vital organ stopped and the patient died. It was further stated that if OM-1 had been opened first, it would have led to any further complication, as the partial blood supply would have continued from LAD and after securing OM-1 the doctor should have opened LAD and even there was some complication, the patient would have got the blood supply from the secured OM-1 and would have survived the procedure. It was further stated that the procedure adopted by Opposite Party No.2 was not the correct procedure, as per the medical books. It was further stated that Opposite Party No.2 should not have tackled LAD first, just because it was easy to do so. Complication occurred while opening LAD, which led to unfortunate outcome. Practice is to secure culprit vessel first. It was further stated that wrong line of treatment has been adopted by Dr.Srinivasan Reddy. Ultimately, a legal notice was sent to the Opposite Parties on 19.11.2016 (Annexure C-8) but surprisingly the issues raised by the complainant were not even touched and purely unrelated recitals were mentioned in reply to the legal notice (Annexure C-9). It was further stated that the aforesaid acts, on the part of the Opposite Parties, amounted to deficiency, in rendering service, and indulgence into unfair trade practice. When the grievance of the complainant, was not redressed, left with no alternative, a complaint under Section 17 of the Consumer Protection Act, 1986 (in short the ‘Act’ only), was filed.

2.           Opposite Party No.1 in its written version, has stated that there was no negligence on the part of Opposite Party No.2, at all because Opposite Party No.2 had shown coronary artery blockages to the attendants of the deceased (including complainant) on the screen/monitor in the catheterization laboratory beside in diagram format. It was further stated that the complainant and his son were well informed and explained about the complications involved in the stenting procedure, the risk involved during the procedure, long term benefits and adverse effects in detail to them and after understanding the same, the complainant had given his written consent. It was further stated that the patient was given full medical care. However, the patient developed pulmonary edema (fluid in the lungs) and hypotension (fall in blood pressure), which Opposite Party No.2 had tried to control by putting best efforts and medical treatment but unfortunately she could not be survived. It was further stated that the complainant had never requested him to go for by-pass surgery and had it been so, why would complainant have given his consent for the stenting procedure.  It was further informed by Opposite Party No.2 that attendants of the deceased were explained about all the available treatment options including opening of all the blockages by putting stents, option of coronary artery bypass surgery, beside the available technology by Opposite Party No.2. After understanding the above aspects, the complainant had agreed for stenting and had given his written consent in this regard. It was further stated that Opposite Party No.2 had informed that during the process of stenting, the patient had bradycardia, for which, injection atropine was given, the said injection increases the heart rate and when the heart rate increases, the response of the coronary arteries is vasospasm (construction of arteries). The coronary vasospasm (construction of artery) was noted in the both LCX (left circumflex) and its branch OM (Obtuse Marginal) which was already having stenosis (blockages). The stenosis in these arteries were situated in the proximal part of the arteries. The patient was having left dominant circulation. The blockages in her arteries were quickly opened by placing a stent in each of her artery, so that all the blocked arteries were opened. In the meantime, the patient had developed pulmonary edema (fluid in lungs) and hypotension (fall in blood pressure). Accordingly, a temporary pacemaker was inserted and the patient was intubated (put on ventilator) and intra aortic balloon pump was inserted to support the blood pressure. The attendants of the patient was shown on the screen/monitors about the opening of the arteries and the complication, which occurred in the form of pulmonary edema. It was further stated that the patient was given full care and given all the available medical support. It was further stated that with regard to shifting the patient to any other hospital, a proper medical advice was given and it is difficult to shift, as there was a temporary pacemaker and intra aortic balloon pump insertion. It was further stated that the patient at all times was given full medical support and was treated to the best of ability of Opposite Party No.2. It was further stated that the procedure of stenting (angioplasty) was done in all the arteries and there was a complication of pulmonary edema, due to which, the condition of the patient deteriorated.  It was further stated that the blood supply of the heart is from 3 major epicardial coronary arteries, which are LAD, LCS and RCA. The patient is a case of unstable angina. The unfortunate complication which occurred in LAD has nothing to do with the blood supply from the other artery. This complication is due to inherent nature of the vessel wall. The artery OM cannot be tackled singularly as it is a branch of LCX and has to be operated simultaneously with its main vessel as bifurcation lesion. Moreover, the blood supply of the coronary artery vessels is to myocardium (muscles of the heart). The collateral supply after occlusion following acute myocardial infarction takes 2-4 weeks. The blood supply from other artery (collateral supply) cannot occur immediately as was hypothesized by the complainant. It was further stated that the diagnostic coronary angiogram does not show visual thrombus (this report is not to be confused or mixed with the coronary angioplasty report). The very fact to identify culprit lesion is not possible as there is no significant ECG changes to suggest exact location. Moreover in females, there can be non specific ST-T ECG changes without any underlying coronary artery disease. The culprit lesion in our case is ambiguous. It was further stated that the complainant had averred that after opening that artery in LAD, the blood supply to the heart had stopped, which is false. All the arteries were opened LAD, LVX and its branch (OM). The location of the culprit lesion is ambiguous in this case in view of the ECG (absence of ST elevation)and significant (<70% stenosis) disease in all the arteries on diagnostic coronary angiogram. It was further stated that the patient had chest pain 7-10 days prior to presentation to our hospital and was already on medications like antiplatet therapy. So, it makes the location of culprit lesion more difficult to diagnose in this particular case. It was further stated that the question that the complainant is alleging to have operated first (0M1) does not hold true as the culprit lesion is ambiguous. The patient has a delayed presentation after acute coronary syndrome to Opposite Party No.1 hospital. In this particular case, the decision is left to the operator at his discretion whichever is best suitable to the condition to operate in a safer way. There is bifurcation lesion in LCX and OM. In the LAD there is a very focal localized lesion. The procedure of LCX/OM is bifurcation stenting which is a complex procedure. Opening of OM artery alone is not possible as a single vessel as the stent proximal edge if operated first will come into the way of LCX and the blood flow will get obstructed. Then the delivery of stent into this LCX will be difficult. Now when all the arteries are critically blocked to open a bifurcation lesion which is more complex requires support of LAD. It was further stated that the averment of the complainant to open the culprit vessel, does not hold true in this particular patient. The complainant repeatedly was interchanging the diagnostic coronary angiography report with the coronary angiogram report. It was further stated that the location of culprit lesion is not clear and in this case as there was multiple blockages. To identify the culprit lesion is difficult especially in multivessel disease in NSTE-ACS (unstable angina). The culprit lesion location, when its identification is not clear, the arguments does not hold true. The opening of LCX requires simultaneous opening of LCX and OM because OM is a branch of LCX. It was further stated that there is absolutely no negligence, at all. It was further stated that neither there was any deficiency, in rendering service, on the part of the replying Opposite Party, nor it indulged into unfair trade practice.

3.           In its written version, Opposite Party No.2 stated that the complainant never requested the replying Opposite Party to go for bypass surgery, had it been so, why would have complainant given his consent for stenting procedure, more particularly when his son, who is a qualified doctor, was accompanying him. The risk of complications involved during the procedure and long term benefits and adverse effects have been explained in detail. The written and informed consent to treat or open all the blockages during the procedure was given by the complainant. Copy of the consent form is Annexure R-1. It was further stated that the blockages in these arteries have been quickly opened by placing a stent in each of the artery, so all the blocked arteries were opened. In the meanwhile, the patient had developed pulmonary edema (fluid in the lungs) and hypotension (fall in blood pressure). Accordingly, a temporary pacemaker was inserted and the patient was intubated (put on ventilator). Intra aortic balloon pump was inserted to support the blood pressure. The attendants were shown on the screens/monitors about the opening of the arteries and the complication which occurred in the form of pulmonary edema. It was further stated that the procedure of stenting (angioplasty) was done in all the arteries and there was a complication of pulmonary edema (fluid in lungs) after which the conditions deteriorated. It was further stated that legal notice has already been replied in detail. It was further stated that in the legal notice, point No.11, the complainant contends that opening of the blockages in LCX first and then LAD. At the same time stressing that OM (a branch of LCX) is the culprit lesion which has to be opened. These both are contradictory statements given by the complainant saying to open both arteries simultaneously (OM and LCX simultaneously). It was further stated that the complainant argued to open the LCX artery first and again mentioned that culprit lesion or OM artery to be opened first. There cannot be two firsts at the same time. The complainant or his doctor son himself is not clear which of these both arteries are to be opened first. It was further stated that no doubt the unfortunate demise of wife of the complainant has occurred, because of the complications involved or developed during the percutaneous coronary procedure (angioplasty and stenting). The complainant is being unfair inspite of the fact that his own son is a qualified doctor who aware that the patient is having multiple blockages is involving all the coronary arteries (triple vessel disease) and the risks associated with the disease. Opposite Party No.2 (Dr.Srinivasan Reddy) took similar objections, as raised by Opposite Party No.1 (GMCH). It was further stated that neither there was any deficiency, in rendering service, on the part of the replying Opposite Party, nor it indulged into unfair trade practice.

3.           The complainant, filed rejoinder to the written statement of Opposite Party No.2, wherein he reiterated all the averments, contained in the complaint, and refuted those, contained in the written version of Opposite Party No.2. 

4.           The Parties led evidence, in support of their case.

5.           We have heard the Counsel for the parties, and have gone through the evidence and record of the case, carefully. 

6.           The first and foremost question to decide is as to whether there was medical negligence by the doctor, who treated the complainant. Before coming to this, let us ponder what is medical negligence ?              Law of negligence has to be applied according to the facts of the case :-

“48. According to Halsbury's Laws of England Ed.4Vol.26 pages 17-18, the definition of Negligence is as under:-&quot;22. Negligence : Duties owed to patient. A person who holds himself out as ready to give medical (a) advice or treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person, whether he is a registered medical practitioner or not, who is consulted by a patient, owes him certain duties, namely, a duty of care in deciding whether to undertake the case: a duty of care in deciding what treatment to give; and a duty of care in his administration of that treatment (b) A breach of any of these duties will support an action for negligence by the patient (c).&quot;

49. In a celebrated and oftenly cited judgment in Bolam v. Friern Hospital Management Committee (1957) I WLR 582 : (1957) 2 All ER 118 (Queen's Bench Division - Lord Justice McNair observed.

&quot;(i) a doctor is not negligent, if he is acting in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art, merely because there is a body of such opinion that takes a contrary view. The direction that, where there are two different schools of medical practice, both having recognition among practitioners, it is not negligent for a 24

practitioner to follow one in preference to the other accords also with American law; See 70 Corpus Juris Secundum (1951) 952, 953, para 44. Moreover, it seems that by American law a failure to warn the patient of dangers of treatment is not, of itself, negligence ibid. 971, para 48).

Lord Justice McNair also observed : Before I turn that, I must explain what in law we mean by &quot;negligence&quot;. In the ordinary case which does not involve any special skill, negligence in law means this : some failure to do some act which a reasonable man in the circumstances would do, or doing some act which a reasonable man in the circumstances would not do; and if that failure or doing of that act results in injury, then there is a cause of action.

59. In Bolam v. Friern Hospital Management Committee (supra), Lord McNair said :&quot;..........I myself would prefer to put it this way : A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men in that particular art.

68. A three-Judge Bench of this court in Bhalchandra alias Bapu&amp; Another v. State of Maharashtra AIR 1968 SC 1319 has held that while negligence is an omission to do something which a reasonable man, guided upon those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do; criminal negligence is the gross and culpable neglect or failure to exercise that reasonable and proper care and precaution to guard against injury either to the public generally or to an individual in 33

72. The degree of skill and care required by a medical practitioner is so stated in Halsbury's Laws of England (Fourth Edition, Vol.30, Para 35):-

36

&quot;The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case, is what the law requires, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operated in a different way; nor is he guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art, even though a body of adverse opinion also existed among medical men.

82. The Privy Council in John Oni Akerele v. The King AIR 1943 PC 72 dealt with a case where a doctor was accused of manslaughter, reckless and negligent act and he was convicted. His conviction was set aside by the House of Lords and it was held thus:-

41

(i) That a doctor is not criminally responsible for a patient's death unless his negligence or incompetence went beyond a mere matter of compensation between subjects and showed such disregard for life and safety of others as to amount to a crime against the State.;

(ii) That the degree of negligence required is that it should be gross, and that neither a jury nor a court can transform negligence of a lesser degree into gross negligence merely by giving it that appellation.... There is a difference in kind between the negligence which gives a right to compensation and the negligence which is a crime.

(iii) It is impossible to define culpable or criminal negligence, and it is not possible to make the distinction between actionable negligence and criminal negligence intelligible, except by means of illustrations drawn from actual judicial opinion....The most favourable view of the conduct of an accused medical man has to be taken, for it would be most fatal to the efficiency of the medical profession if no one could administer medicine without a halter round his neck.&quot;

The Hon’ble Apex Court in the judgment titled as “Kusum Sharma & ors. Vs. Batra Hospital, Civil Appeal No.1385 of 2011, decided on 10.02.2010 had discussed the above facts regarding medical negligence.

7.           In the instant case, Opposite Party No.2 had performed stenting procedure to the best of his skills and medical acumen. Opposite Party No.2 had shown coronary artery blockages to the attendants of the deceased (including the complainant) on the screen/monitor in the catheterization laboratory, besides in diagram format. The complainant and his son were well informed about the complications involved in the stenting procedure, the risk involved during the procedure, long term benefits and adverse effects in detail to them and after understanding the same, the complainant had given his written consent. The patient Smt.Baby Rani Bansal (since deceased) was given full medical care, all medical support and was treated by Opposite Party No.2 with the best of his ability. Opposite Party No.2 had informed that during the process of stenting, the patient had bradycardia, for which, injection atropine was given., which increased the heart rate and when the heart rate increased, the response of the coronary arteries is vasospasm (construction of artery) was noted in the both LCX (Left Circumflex) and its branch OM (Obtuse Marginal), which was already having stenosis (blockages). The stenosis (blockages) in these arteries were situated in the proximal part of the arteries (close to the origin). The patient was having left dominant circulation.  The blockages in her arteries were quickly opened by placing  a stent in each of her artery,so that all the blocked arteries were opened. In the meanwhile, the patient had developed pulmonary edema (fluid in the lungs) and hypotension (fall in blood pressure). Accordingly, a temporary pacemaker was inserted and the patient was intubated (put on ventilator) and intra aortic balloon pump was inserted to support the blood pressure. The attendants of the patient were shown on the screen/monitors about the opening of the arteries and the complication. The patient was given full care and given all the available medical support. To the question of shifting the patient to any other hospital, a proper medical advice was given that it is difficult to shift as there was a temporary pacemaker and intra aortic balloon pump insertion. For treatment of pulmonary edema, ventilator support was given to her, besides for increasing the blood pressure, injection inotropes and intra aoric balloon pump was inserted. Throughout, the patient was given full medical support. In Column No.16 of the Death Report/Death Certificate shows summary of cause of death, which was “CAD, Triple Vessel Disease, unstable angina, post angioplasty, cardiogenic shock, pulmonary edema.” Further, it was observed that by Opposite Party No.2 that the procedure of stenting (angioplasty) was done in all the arteries and there was a complication of pulmonary edema (fluid in lungs), due to which, the condition of the patient deteriorated. The complainant in this case averred that OM 1 had 95% blockade with thrombotic occlusion. The diagnostic coronary angiogram never reports or mention any thrombus anywhere in any of the arteries. The coronary angiogram contains the report of stenosis (blockages) and intended plan of the procedure. The coronary angioplasty report contained details of the entire procedure after the initial coronary angiogram. During the procedure there are multiple events, which occurred and everything described in detail. The patient was a case of unstable angina. The diagnosis of culprit lesion in unstable angina with multiple stenosis (blockages) is not easy without any significant ECG changes. The unfortunate complication, which occurred in LAD has nothing to do with the blood supply getting from the other artery. This complication is due to inherent nature of the vessel wall. The artery OM cannot be tackled signgularly as it is a branch of LCX and has to be operated simultaneously with its main vessel as a bifurcation lesion. The complainant in this case averred that after opening LAD, the blood supply to the heart had stopped, which is false. All the arteries were opened i.e. LAD, LCX and its branch (OM). The location of the culprit lesion is ambiguous in this case in view of the ECG Report (absence of ST elevation) and significant (>70% stenosis) disease in all the arteries on diagnostic coronary angiogram. Opposite Party No.2 had clearly stated that going by the history of the patient, the patient was suffering from chest pain 7-10 days prior to presentation to Opposite Party No.1 hospital and was already on medications like antiplatet therapy (tab. Ecospirin gold) and anticoagulant therapy (loparin 0.6 ml S/C BD) therapy, which makes the location of culprit lesion more difficult to diagnose.  The patient had a delayed presentation after acute coronary syndrome to the hospital. To summarise, in this present case, the decision is left to the operator at his discretion whichever is best suitable to the condition to operate in a safer way. There is bifurcation lesion in LCX and OM. In the LAD there is a very focal localized lesion. Opening of OM artery alone is not possible as a single vessel, as the stent proximal edge, if operated first will come into the way of LCX and the blood flow will get obstructed.  Then the delivery of stent into this LCX will be difficult. The support of LAD is required to open all the blocked arteries. The averment of the complainant that OM was a culprit vessel and had to be opened first does not hold true. Opposite Party No.2 had full freedom to exercise on the operation table as to what procedure is beneficial to the patient. Opposite Party No.2 put into practice the best possible medical remedy available to him in doing the angioplasty. He was the best judge of the situation. Going by the principles of medical negligence, as brought in the Hon’ble Apex Court judgment, referred to above, we find that there is no case of medical negligence and the complaint deserves to be dismissed.

8.           In view of above, this complaint stands dismissed with no order as to costs.

9.           Certified Copies of this order be sent to the parties, free of charge.

10.         The file be consigned to Record Room, after completion.

Pronounced.

July 11^th, 2018.                                     

[JUSTICE JASBIR SINGH (RETD.)]

[PRESIDENT]

 

 

 [DEV RAJ]

MEMBER

 

 

 (PADMA PANDEY)

        MEMBER

rb