Delhi

StateCommission

C-128/2001

MR. A.P. SINGH AND OTHERS - Complainant(s)

Versus

BATRA HOSPITAL AND MEDICAL RESEARCH CENTER OF CH. AISHA RAM BATRA PUBLIC CHRITABLE TRUST THROUGH ITS - Opp.Party(s)

14 Jun 2018

ORDER

IN THE STATE COMMISSION: DELHI

(Constituted under Section 9 of the Consumer Protection Act, 1986)

                                                             Date of Decision: 14.06.2018

 

Complaint No. 128/2001

 

In the matter of:

	Mr. A. P. Singh s/o. Late S. Gurdial Singh R/o. L-264, Sector 25, NOIDA, UP	:
	Mr. Harpal Singh S/o. A. P. Singh R/o. L-264, Sector 25, NOIDA, UP
	Mr. Ruppal Singh S/o. A. P. Singh R/o. L-264, Sector 25, NOIDA, UP		Complainants

           

Versus

 

	Batra Hospital & Medical Research Centre Of Ch. Aishi Ram Batra Public Charitable Trust THROUGH ITS DIRECTOR 1, Tughlakabad Institutional Area, New Delhi-110062	:
	Dr. Balbir Singh, Cardiologist Batra Hospital & Medical Research Centre 1, Tughlakabad Institutional Area, New Delhi-110062
	Dr.  S. K. Sinha, Cardiac Surgeon Batra Hospital & Medical Research Centre 1, Tughlakabad Institutional Area, New Delhi-110062		Respondents

 

                            

CORAM

 

N P KAUSHIK

:

Member (Judicial)

 

1.         Whether reporters of local newspaper be allowed to see the judgment?                   Yes

2.         To be referred to the reporter or not?                                                                  Yes

 

 

Case Relied Upon

 

1.         Sulochana Lad vs. Dr. Mohan Gerra & Anr., IV (2016) CPJ 505 (NC)

2.         Malay Kumar Ganguly vs. Dr. Sukumar Mukherjee, 2009 (3) CPJ 17 SC

 

N P KAUSHIK – MEMBER (JUDICIAL)

 

 

JUDGEMENT

1. Complainant no. 1 is the husband and the complainants no. 2 & 3 are the sons of the deceased Smt. Baljeet Kaur who was 50 years of age when she decided to get a permanent cure of irregular heart beat.  On 07.06.1999 she was admitted to Batra Hospital and Medical Research Centre, 1, Tughlakha Bagh Institutional Area, New Delhi (in short OP1) for Radio Frequency Ablation (RFA).  Dr. Balbir Singh, Cardiologist (in short OP2) and Dr. S. K. Sinha, Cardiac Surgeon (in short OP3) were treating doctors and working in OP1 hospital. 

 

2. Procedure of Radio Frequency Ablation was started at 5.00 pm on 07.06.1999.  Grievance of the complainants is that the patient Smt. Baljeet Kaur was not relieved.  They were not even told as to what complications had occurred.  They were asked to arrange for blood and platelets.  They ran from one hospital to another continuously for 36 hours.  Upon inquires it was revealed that during the procedure, the heart of the patient got perforated which was either due to excessive heat given by OP2 and its team or by deeper penetration of catheter into the heart.  The process of Radio Frequency Ablation is that in no case the catheter is penetrated into the heart.  Process itself is meant to defuse the AV Nodes which is located outside and on the wall of the heart.  For managing perforation in the heart, the patient was put to open heart surgery.  She used to be taken in and out of the operation theatre uptil 12.06.1999.  Ultimately patient Smt. Baljeet Kaur was declared dead at 9.50 p.m. on 14.06.1999. 

 

3. Complainants submitted that the patient Smt. Baljeet Kaur was suffering from PAT (Paroxysmal Atrial Tachycardia).  In this procedure catheter is inserted through artery to defuse the AV nodes from where the alternate impulse is sent to the heart.  Medical procedure does not even require any anaesthesia – local or general.  Contention of the complainants is that the doctors of OP1 hospital, negligently perforated the heart of the deceased who expired due to excessive bleeding. 

 

4. Defence raised by OP1 hospital and treating doctors (OP2 and 3) is that the patient Smt. Baljeet Kaur was having repeated episodes of supraventricular tachycardia which as per records was quite symptomatic with even transient unconsciousness.  The drug therapy (Amiodarone) given, was producing significant side effects (photosensitivity and hypothyroidism).  So the treatment option of Radio Frequency Ablation was really warranted. 

 

5. All the OPs contended that Radio Frequency Ablation is fairly safe procedure though rarely complications like complete heart block, pericardial tamponade and death are reported even from the most experienced centres in the World.  The report incidence of pericardial tamponade was 0.2% in some of the series from large volume centers.   OPs further submitted that all consequences of the procedure were written in the informed consent form which was duly signed by the patient’s relatives.  The patient unfortunately suffered from cardiac rupture following Radio Frequency Ablation causing pericardial tamponade leading to hypotension and urgent open heart surgery to seal the tear in the heart.  Giving details of the treatment, OPs submitted that the tachycardia was localised to the left side of the heart under the mitral annulus and was labelled as a left free wall accessory pathway.  An ablation catheter was introduced from femoral artery and placed at the mitral annulus.  A Radio Frequency lesion was delivered at this point which resulted in ablation of the conduction across the accessory pathway.  However the patient developed hypotension and bradycardia.  An urgent echocardiogram was done in the cath lab itself which revealed pericardial effusion.  Pericardiocentesis was done which revealed hemorrhagic fluid.  In view of cardiac temponade, the cardiac surgeons were contacted who immediately attended the patient.  In fact  the anaesthesiologist from the surgical team was present in the cath lab throughout the procedure.  The procedure in this patient was not to defuse the AV node as this was not the cause of her tachycardia and in fact it was a left case of sided accessory pathway.  This fact was already explained to the husband of the patient. 

 

6. OPs submitted that the heart of the patient had perforation and had raised the epicardium dissecting the heart muscles which usually happens in these  cases.   The exact point of perforation gets diffused supporting sutures to stop bleeding. Surgical glue was also placed.  Only when the bleeding stopped the patient was shifted to ICU.  However, the bleeding restarted and patient was re-explored.  Edema of the heart due to multiple transfusion and opening was there and hence sternum could not be closed.  Attendants of the patient were asked to get more blood and platelets only when the blood bank stores of OP1 hospital were exhausted. 

 

7. OPs submitted that OP1 Hospital had fully equipped blood bank and was catering to 1300 open heart surgeries a year.     The blood and platelets were available round the clock.  However in any emergency, OP1 hospital relied upon the other blood banks in the city.  The OPs placed reliance upon the following medical literature:
   1. Delayed sternal closure; a lifesaving maneuver after early operation for complex congential heart disease in the neonate – JN Odim, CI Tchervenkov and AR Dobell.

 

2. Delayed sternal closure; An improved method of dealing with complications after cardiopulmonary bypass – M Josa, SF Khuri, NS Braunwald, MF Vancisin, MP: Spencer, DA Evans and EM Barsamian.

 

3. Delayed sternal closure after cardiac surgery – WJ Fanning, JS Vasko and JW Kilman.

 

4. Delayed closure of the median sternotomy incision – DA Murphy.

 

 

8. Complainants placed on record their rejoinder.  Affidavits towards evidence were also filed by the parties. Written arguments were filed by the parties.  Oral arguments addressed by Counsels for the parties were heard.
9. Before proceeding further it may be mentioned here that this Commission sought experts’ opinion in the matter from the Dean, Maulana Azad Medical College, New Delhi.  The same was received vide letter dated 27.08.2011.  It is reproduced below:

               “The committee constituted by Nodal Officer on direction from State Consumer Dispute Rederessal Commission Forum Delhi, has examined the case no. C-2001/128 titled Sh. A.P. Singh & Ors. Vs. Batra Hospital & Medical research center and Ors.

 

The patient Baljeet Kaur was having repeated episodes of supraventircular tachycardia which as per the records were quite symptomatic with even transient unconsciousness.The drug therapy (Amiodarone) given was producing significant side effects (photosensitivity and hypothyroidism).So the treatment option of Radio Frequency Ablation was really warranted.

 

Radio Frequency Ablation is fairly safe procedure though rarely complications like complete heart block, pericardial tamponade and death are reported even from the most experienced centres in the World.The report incidence of pericardial tamponade was 0.2% in some of the series from large volume centers. As perthe records available all consequences of the procedure was written in the attached informed consent form which is duly signed by the patients relatives (though their names are not mentioned, neither the doctor who took the consent has signed the form) Name and signature of witness is also missing.

 

The patient unfortunately suffered cardiac rupture following Radio Frequency Ablation causing pericardial tamponade leading to hypotension and urgentoipen heart surgery to seal the tear in the heart.We went in detail through the hospital records and are of the opinion that best possible attention was given to manage this unfortunate complication.The course that followed ultimately leading to death was unfortunate but no negligence of any kind could be observed.Even asking to arrange for blood from other centers is quite justifiable considering the enormous volume of blood that was needed somehow to save the patient’s life.The committee is of the opinion that there is no case against the hospital and the doctors concerned considering the fact that best possible efforts were taken to address this rare complication except few deficiency (as mentioned above) in consent form.

 

 

Prof. Muhammad Abid Geelani

Prof. Dinesh Dhanwal

Dr. Sumod Kurian

 

10. Sole question that arises in the present case is whether the experts’ opinion is correct or not.  Experts opined that incidence of pericardial tamponade was 0.2%.  The complications of pericardial temponade though rare but have been found occurring in 0.2% of the cases.  In support of their contention that the complications of pericardial tamponade occurs in 0.2% cases, OPs have placed on record the medical literature as well.  On the contrary complainants have not questioned the correctness of either the experts’ opinion or the medical literature relied upon by the OPs.  Complainants have not examined any expert to show that the experts’ opinion was not correct.  In their affidavits towards evidence, the complainants have not challenged the correctness of the experts’ opinion.  Supreme Court in the case of Malay Kumar Ganguly vs. Dr. Sukumar Mukherjee, 2009 (3) CPJ 17 SC held as under :

“relied on the principles above quoted and held, “such opinions (of experts) have been rendered on the basis of their expertise.They were notarized.The said opinions have been appended to the complaint petition even as documents.Respondents did not question the correctness thereof either before the court or before the Commission.They did not examine any expert to show that said opinion are not correct.The concerned respondents in their depositions before the Commissions also did not challenge the correctness or otherwise of the said opinions.”

 

 

11. In the absence of any material challenging the correctness of experts’ opinion I find it difficult to agree with the complainants that there was any ‘negligence’ on the part of the OP Hospital or the treating doctors.

 

12. Perusal of the consent form dated 07.06.1999 shows that the same does not bear the signatures of the doctors.  It also does not indicate the names of the relatives who were explained the prognosis and the likely consequences of the procedure.  OP1 Hospital has thus been ‘deficient in service’ in obtaining the informed consent of the patient or her attendants.  I place reliance on the case of Sulochana Lad vs. Dr. Mohan Gerra & Anr., IV (2016) CPJ 505 (NC).  Relevant paras of the said judgement are reproduced below. 

“21.     Fundamentally, the law requires the disclosure to the patient, information relating to the diagnosis of the disease; nature of the proposed treatment; potential risks of the treatment and the consequences of the patient refusing the suggested line of treatment.  Disclosure of such information is the basic attribute of an informed consent and is considered mandatory in every field of medicine or surgical procedure.  The only exception to the general rule is the emergency medical circumstances, where either the patient is not in a medical condition or mental stage to take a conscious decision in this regard.  In India, the standard of disclosure of information to the patient regarding ailment and recommended treatment, with attendant risks of treatment, necessary to secure his information.  Consents, as ensuciated in bolam vs. Frierl Hospital Management Committee (1957) 2 All.ER 118 commonly referred to as the Bolam Test, is being applied.  The standards laid down in Bolam, were: (i) when a vhope of cure was submission to a particular therapy, he could not be critised if, beliving the danger involve4d in the treatment to be minimal, did not stress them to the patient.  In other words, what degree of disclosure of risks, is best calculated to assist a particular patient to make a rational choice as to whether or not to undergo a particular treatment must primarily  be left to clinical judgement of the doctor: and (ii) in order to recover damages for failure to give warning about the danger, the complainant must show not only that the failure was negligent but also that if he had been warned, he would not have consented to the treatment. 

            22.       In Malay Kumar Ganguly vs. Sukumar Mukherjee and Others, III (2009) CPJ 107 (SC) dealing with the question of right of the patient to be informed about the recommended treatment for the ailment he is suffering from and the risks involved in the treatment, while observing that the only reasonable guarantee  a patient’s right of bodily integrity and self determination is for the Courts to apply a stringent standard of disclosure in conjunction with a presumption of proximate cause, at the same time, a reasonable measure of autonomy for the doctor is also pertinent to be safeguarded from unnecessary interference, the Hon’ble Supreme Court said as follows:

            “142. Patient’s by and large are ignorant about the disease or side or adverse effect of a medicine.  Ordinarily the patients are to be informed about the admitted risk, if any.  If some medicine has some adverse effect or some reaction is anticipated, he should be informed thereabout.  It was not done in the instance case.  In Sidaway vs. Board of Governors of Bethlehem Royal Hospital The House of Lords, inter alia held as under : (WLR PP.504 H – 505 C)

“The decision what degree of disclosure of risks is best calculated to assist a particular patient to make a rational choice as to whether or not to undergo a particular treatment must primarily be a matter of clinical judgement:  

An issue whether non-disclosure of a particular risk or cluster of risks in a particular case should be condemned as a breach of the doctor’s duty of care is an issue to be decided primarily on the basis of expert medical evidence.In the event of a conflict of evidence the judge will have to decide whether a responsible body of medical opinion would have approved of non-disclosure in the case before him.

 

A judge might in certain circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it, even in a case where no expert witness in the relevant medical filed condemned the non-disclosure as being in conflict with accepted and responsible medical practice.”

 

143. The law on medical negligence also has to keep up with the advances in the medical science as to treatment as also diagnostics. Doctors increasingly must engage with patients during treatments especially when the line of treatment is a contested one and hazards are involved. Standard of care in such cases will involve the duty to disclose to patients about the risks of serious side effects or about alternative treatments. In the times to come, litigation may be based on the theory of lack of informed consent.   

 

144.  

 

In Samira Kohli (supra), the principles, relating to Consent, have been summarized as follows:

	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 he 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 conpsent 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 Canterbur`y 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.”

 

13. In view of the discussion above, I am of the considered opinion that the OP1 hospital has been ‘deficient in service’.  OP1 hospital, is therefore, directed to compensate the complainants for the aforesaid ‘deficiency in service’ by paying compensation to the tune of Rs.2 lakhs alongwith interest @7% per annum from the date of institution of the complaint till the date of its realization.  OPs are directed to comply with the aforesaid orders within a period of 30 days from today failing which the amount shall carry an interest @18% per annum.  Complaint is accordingly disposed of.  File be consigned to records.

 

(N P KAUSHIK)

MEMBER (JUDICIAL)

13.