Delhi

StateCommission

C-27/2004

Dilip Kumar Goswami, S/o Late Sh. G.C. Goswami - Complainant(s)

Versus

Batra Hospital and Medical Research Centre - Opp.Party(s)

22 Jun 2018

ORDER

IN THE STATE COMMISSION: DELHI

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

 

                                                             Date of Decision: 22.06.2018

 

Complaint No.27/2004

 

In the matter of:

Jyoti Bezbarua Goswami W/o. Late Sh. Dilip Kumar Goswami R/o. House No. 199, Punjabari Guwahati-781037

:

Complainant

           

Versus

 

 

	Batra Hospital & Medical Research Centre, For Chaisi Ram Batra Public Charitable Trust, 1, Tughlakabad Institutional Area,  Mehrauli Badarpur Road, New Delhi-110062,	:	Respondents
	Professor (Dr.) Upendra Kaul Director, Interventional Cardiology, Electrophysiology, Batra Hospital & Medical Research Centre, New Delhi-110062.
	Dr. B. Singh, Senior Interventional Cardiologist, Batra Hospital & Medical Research Centre, New Delhi-110062.
	Dr.  S. Sapra, Senior Interventional Cardi ologist, Batra Hospital & Medical Research Centre, New Delhi-110062.
	Dr. A. K. Parida, Senior Resident Batra Hospital & Medical Research Centre, New Delhi-110062.
	International Hospital A Unit of Assam Hospital Ltd. Lotus Tower, GS Road, Guwahati
	Dr. Tanmoy Das, Director International Hospital Lotus Tower, GS Road, Guwahati
	Dr. C. K. Boro, Senior Cardiologist, GNRC Hospital, Disur, Guwahati-781006
	Sri Tapan Paul Medtronics Local Pace Maker, Canon Street Devices Pvt. Ltd. 23/3A, AJC Bose Road, Kolkata-20

 

                            

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

 

 

Cases relied upon:

 

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

 

 

N P KAUSHIK – MEMBER (JUDICIAL)

 

JUDGEMENT

1. Present complaint alleging medical negligence against Batra Hospital & Medical Research Centre, Tughlakabad Institutional Area,  New Delhi, was filed by the initial complaint Sh. Dilip Kumar Goswami during his life time.  Complainant died during the pendency of the present complaint.  After his death, his wife, Smt. Jyoti Bezborugh prosecuted the same.   Original complainant Sh. Dilip Kumar Goswami aged 53 years at the time of filing of the complaint was working as Dy. General Manager (Legal) in Guwahati (Assam) in Nutmaligarh Refinery.  Complainant submitted that from the year 1992-93, he had been feeling occasional palpitation of the heart lasting for a few minutes and sometimes few hours.  Sometimes there used putting an interval of one year or two years in such palpitations.  International Hospital Lotus Tower, GS Road, Guwahati, Assam (in short OP6) conducted routine health check up of the complainant.  He was suspected as suffering from WPW syndrome.  He was advised to visit Batra Hospital & Medical Research Centre,  Tughlakabad Institutional Area  New Delhi (in short OP1) for specialised test known as Electro Physiology Study for detection of WPW Syndrome.  Accordingly on 15.11.2002, complainant visited OP1 where he was referred to meet Professor (Dr.) Upender Kaul (in short OP2).  OP2 stated that the complainant was a known case of PSVT and required to undertake Electro-Physiology study and Radio Frequency Ablation (RFA).  Charges for the said treatment were Rs.30,000/- plus other costs and charges.  Upon this the complainant asked OP2 to explain him the procedure of RFA.  OP2 explained to him that RFA was a treatment for WPW syndrome.  He was further told that in case electro physiological study suggested it was a fit case for RFA, the said treatment would be resorted to.  He was also told that in case it appeared from the said study that the case did not require RFA, or the physical condition did not permit Ablation alternative treatment would be advised.  In case of simple study patient would be required to pay Rs.10,000/- and Rs.20,000/- would be charged in the event of treatment.  Complainant was asked by OP2 to see him on 23.12.2002 at 8.30 a.m.  Complainant agreed to undergo the said study.  He paid Rs.10,000/-  being the charges for the said study.  He was admitted at 8.30 a.m. on 23.12.2002 in OP1 hospital.  He was taken to Cath Lab where after administration of intravenous sedative, the said study commenced.  It continued for more than 4 hours and thereafter the complainant was shifted to CCU for observation.  OPs No. 2 to 5 who had conducted the said study informed that the study would be continued for the next day too.  On 24.12.2002 i.e. the next day, he was taken for study and intravenous was administered.  After the purported study OP2 to 5 (the treating doctors) told the complainant that the blockage of his heart had arisen.  To save his life a temporary pacemaker had been installed.  A permanent double chamber pacemaker was to be installed for a cost of Rs.1.7 lakhs plus other charges.  Complainant was once again sent to CCU and advised to deposit the money.  Grievance of the complainant is that only at this stage he came to know that during the treatment of RFA he developed heart blockage.  A certificate to this effect was issued.  In the same certificate it was mentioned that the reason of heart blockage was that the pathway was very close to the conduction system.  Complainant contacted his wife.  Contention of the complainant is that OPs 1 to 5 without waiting for the arrival of his wife took him to the operation theatre and implanted a pacemaker.  Complainant was in a state of shock and fear of death.  He was in no frame of mind to take any decision.  On 26.12.2002 at about 10.30 am, OP2 to 5 implanted a pacemaker.  Complainant’s wife due to delay in flight arrived at OP1 hospital only at about 9.30 p.m.  On 28.12.2006 the complainant was discharged and advised to revisit on 02.01.2003 for removal of stitches.  Stitches were removed on 02.01.2003 and the complainant accompanied by his wife returned to Guwahati on 04.01.2003.  Uptil 10.01.2003 the complainant did not feel any discomfort.  On 10.01.2003, the complainant felt vibration of the chest muscles accompanied by an irregular heartbeat.  Complainant immediately contacted the OP2 in Delhi over telephone.  They casually advised him to meet OP8 in Guwahati for treatment and advice.  Acting on such advice complainant visited OP8 in Guwahati who after examining advised him to call the local agent of the pacemaker implanted (in short OP9) who accordingly reprogrammed the pacemaker by reducing the Atrial Voltage from 3.5 V to 2.5 V.  Despite the above programming on 15.01.2003, complainant experienced minor beating of the heart signals.  As advised the complainant consulted OP8 once again and apprised him of the continuing discomfort.  Once again, OP9 programmed the pacemaker on 18.01.2003 as per advice of OP8.  This time, the ventricular lead voltage was reduced from 3.5 V to 2.0 V and V threshold from 0.7 V to < 0.5 V.    OP9 on further examination and study and considering the nature of discomfort, told the complainant that the lead of the pacemaker might be touching the Heart muscles directly and, therefore, the complainant should immediately contact OP2 who had implanted the pacemaker. 

 

2. On 08.02.2003 complainant visited OP3 Hospital and met OP4 “(Dr. S. Sapra of OP1 hospital).  Dr. Sapra informed the complainant that the second chamber of the pacemaker was not functioning.  Complainant was taken for echo cardiography by which it was found that one lead of the pacemaker implanted had pierced out of the heart and the bleeding had sopped due to clotting of the blood.  Complainant was advised immediate operation or else at any moment there might intense bleeding and leading to death of the complainant.  Complainant further submitted that on 11.02.2003, he was once again admitted and operated upon the same day.  A new pacemaker lead was inserted under local anaesthesia making the pacemaker functional.  Thereafter open heart surgery was conducted and the lead piercing the heart was pulled out.  Hole made in the heart by the lead was stitched/ repaired.

 

3. Complainant submitted that the OP1 and 2 alongwith other OPs were jointly and severally responsible for negligence and lapses in implanting the pacemaker in the first instance which caused permanent damage to the heart muscles apart from their lapses  and latches in administering the treatment of RFA without taking consent and ignoring the physical condition which indicated risk of blockage of heart and necessity of implantation of pacemaker.

 

4. Complainant further submitted that the OP2 while conducting the open heart surgery for the second time took no care to ensure that the implantation was correctly done.  Complainant continued to suffer physical discomfort, stress and agony.  Complainant consulted another specialist who informed that the pacemaker had not been properly implanted.  His advice dated 23.10.2003 was filed by the complainant. 

 

5. On the basis of the aforesaid facts, complainant raised certain questions of alleged ‘medical negligence’ and ‘deficiency in service’.  He raised certain issues which appear at points a) to m) in para 41 of the complaint.  Finally, the complainant summarised his grievances as under:
   1. treatment of RFA was undertaken without disclosing to him the report of RFA study.

 

2. It was done without his knowledge and consent and RFA was done under guise of electro physiology study. 

 

3. Other options for treatment which were less risky and less life threatening were not considered before taking up of RFA.

 

4. Complainant was not diagnosed to be in a condition of risk of death without treatment. 

 

5. His heart which was in good condition was damaged.  In the process of conducting RFA, a heart blockage was caused.

 

6. A temporary pacemaker was implanted without care resulting piercing of the heart,  making a hole and putting his life to risk.  Now an open heart surgery became a must to repair the hole made in the heart.  

 

7. Complainant who was living a normal life became unfit.  It was due to the medical negligence lapses and deficiency in service on the part of the OPs.

 

 

6. Complainant submitted that he suffered mental stress, physical suffering, agony and damage.  He suffered loss of normal living and life expectancy.  He also had to pay costs for third operation for repositioning the pacemaker earlier wrongly implanted.  Complainant thus claimed an amount of Rs.80 lakhs towards compensation. 

 

7. OPs 1 to 5 i.e. Batra Hospital & Medical Research Centre,  Tughlakabad Institutional Area,  New Delhi and its treating doctors filed their joint written version.   These OPs at the outset disclosed in brief the nature of WPW syndrome.  They submitted that WPW Syndrome was a disease caused by the presence of an accessory conduction pathway in the heart.  Such an accessory pathway is present since birth and the presence is diagnosed by ECG.  This accessory pathway is responsible for the episodes of fast heart beating which in medical terms is called Paroxysmal Supraventricular  Tachycardia (PSVT).  Such fast heart beating may also cause giddiness/ unconsciousness which can be harmful and life threatening.   In such cases, medical recommendation is to undergo electro physiology study (EPS) and radio frequency ablation.  The electro physiology study is performed not to confirm the diagnosis (which is obvious from ECG) but to locate the accessory pathway prior to ablation.  For these reasons, the patients are advised EPS and RFA as a combined procedure.  Procedure is done under local anaesthesia. 

 

8. Next submission of the OPs No.1 to 5 is that the occurrence of heart block is a rare complication of Radio Frequency Ablation.  But if it occurs, it needs to be treated by doing permanent pacemaker implantation (PPI).  Keeping a patient on temporary pacemaker alone for long, is not advisable as it is an external device and is prone to infection and is also at a risk of displacement as temporary leads do not have any fixation device inside the heart. 

 

9. OP No. 1 to 5 submitted that the complainant in the present case developed a rare complication, the occurrences of which were not predictable.  ‘Informed and signed consent’ of the complainant was obtained before starting the procedure.  Cost of EPS in OP1 Hospital was Rs.20,000/- and Rs.10,000/- were taken as initial deposit.  Cost of RFA was Rs.30,000/-.

 

10. In its rejoinder, complainant submitted that OP2 on perusal of ECG report recorded on the patient’s card his findings: “documented PSVT, need of EPS + RF Ablation and prescribed medicine, to be stopped 2 days before procedure with further noting, estimate for EPS + RFA”.  Complainant further submitted that no effort was made in identifying or classifying the category of WPW syndrome.  He further submitted that he was not explained anything about his condition if the WPW syndrome was life threatening.  He was not explained the mode of treatment available i.e. by either medication or by EPS and RFA.  Seriousness  and risk factor of the treatment by Ablation and treatment of medication were also not explained.  No option was given for his preference.  Rather the complainant was given to understand that it was after the study that the treatment of RFA would be done depending on the physical condition of the pathway on mapping which was a very minor thing without having any element of risk.  Contention of the complainant is that in his case, RFA was undertaken without discussing and informing the danger, risk factor and damage that might be caused in the course of RFA treatment.  He was not advised to come with his family members while reporting for EPS and RFA.  He was casually advised to report for EPS and RFA.  Complainant raised following queries in his rejoinder:
    1. “Whether any study is required to ascertain the degree of WPW syndrome by test or otherwise before giving the advise for EPS and RFA?

 

2. Whether the symptoms disclosed by me was sufficient for comprehensive diagnosis to recommend treatment by EPS and RFA?

 

3. Whether my case was fit for treatment by medication only?

 

4. Whether I was discussed and given the options of treatment by medication?

 

5. Whether prior to the advice to undergo EPS and RFA I was discussed and informed about the danger, damage and risk factor involved in undergoing RFA treatment?

 

6. Whether consent was taken for EPS and RFA after discussion and informing the risk factor and danger of RFA?

 

7. Why I was not advised to be accompanied by elderly and responsible person in consideration of the known risk factor involved in RFA treatment?

 

8. What did the mapping in course of EPS reveal about the location of my by-pass pathways?

 

1. Whether the video imaging in course of EPS revealed closeness of the bypass pathway to conduction system as noted in Annexure P-4 which caused heart block at the time of ablation of the area of the heart?”

 

11. Complainant submitted that he did not suffer heart blockage in natural course due to any ailment and defect in the heart or due to any physiological defect.  He stated that the heart blockage was attributable to the OPs’ act of neglect and unethical motive in making money in the guise of giving treatment by use of advanced technology imported from foreign country.  OPs never diagnosed him as having defective heart which could suffer blockage without the treatment of RFA.

 

12. Coming to the second complication relating to the lead of the pacemaker piercing the heart, complainant submitted that the OPs simply described that without disclosing any cause.  Effect of perforation of his heart  by the lead took place due to lapses and latches on the part of OP1 and OP2 in implanting the pacemaker.  His healthy heart was perforated and damaged by the wrong implanting of it and had to be repaired by open heart surgery. 

 

13. Coming back to the procedure of EPS and RFA, complainant stated that after finding the closed location of pathway, he should have been explained the risk factor.  His consent in writing should have been obtained.  Doctors proceeded for ablation ignoring the finding of closeness of pathyway, not as life saving measure but for completing the alleged treatment by RFA and billing.  WPW syndrome was not life threatening in his case. 

 

14. Dr. Tanmoy Das, Director International Hospital, Lotus Tower, GS Raod, Guwahati (OP No.7), stated in his defence that the complainant had approached him for treatment of his ailment.  After proper examination, he was suspected to be suffering from WPW syndrome.  Electro physiology study was required in his case.   There was no hospital in Eastern India having the facilities for conducting EPS.  Upon the request of the complainant, he was advised to go to OP1 Hospital.  He stated that he could not be made liable for any advice given in good faith. 

 

15. This Commission invited the experts’ opinion vide letter dated 24.02.2011.  Maulana Azad medical College, New Delhi, vide its letter dated 30.03.2012 submitted the report given by the Board of Doctors.  Points of reference with the reply given by the Board of Doctors are reproduced below:
16. Before RFA:

 

1.  
2.  

 

1. •  

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

17.  

 

1.  

 

During RFA:

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

Pacemaker implantation:

 

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

1.  
1.  

 

“Considering above, was there any negligence from Batra Hospital and/ or the attending Doctors anytime during entire course of treatment & operation of the petitioner?”

 

“In view of the above, the documentation would have been more adequate if we were provided with EPS and ECG traces the EPS-RFA trace provided to us vide letter (3027-30) dated 16.02.2012 is actually a chroscopic impage and not an EPS trace.”

 

There seem to be no negligence from Batra Hospital and/ or attending Doctors anytime during entire course of treatment and operation of petitioner.”

 

           

 

           

Dr. VK Trehan Professor, Cardiology, GB Pant Hospital

Dr. D. K. Satsangi, Dir Prof. (CTVS), GB Pant Hosptial

Dr. M.K. Daga, Dir. Prof. (Medicine), MAMC”

 

 

16. This Commission vide orders dated 06.09.2011 and 10.02.2012 directed the OP1 hospital to file ECG traces report.  Orders dated 10.02.2012 being relevant are reproduced below:
    • Pursuant to order dated 06.09.2011 the hospital has filed only EPS-RFA traces report. ECG traces report has not been filed.  It’s consequences will be considered at the time of judgement.  A copy of EPS-RFA traces report in this case be sent to Dr. PC. Dikshit, HOD (Forensic Medicine) & Nodal Officer, MAMC.  Board of experts will send their opinion in this case within two months this copy reaches there.  Alongwith the letter, be sent to Dr. Dikshit copy of order dated 17.01.2011 and copy of order being passed today.”

 

 

17. While filing EPS – RFA Image on 23.11.2011, OP No.1 to 5 stated that ECG was given to the patient at the time of his discharge.  The discharge summary relating to the discharge dated 28.12.20023 does not show the handing over of the ECG to the patient at the time of discharge.  There is no other document filed by the OPs in support to the said contention. 

 

18. Parties placed on record their affidavit towards evidence.  Written arguments too were filed by the parties.  I have heard at length the arguments addressed by the Counsel for the Complainant Sh. Neguive and the Counsel for the OPs Ms. Anita Pandey.   OPs also filed on record a copy of the Article Wolff-Parkinson-White Syndrome Treatment & Management by Christopher R Ellis, MD, FACC; Chief Editor, Jeffrey N Rottman, MD, updated 11.02.2013.

 

19. Broadly, the complainant in the present case suffered two problems. He was taken to the procedure of EPS and RFA on 23.12.2002.  During this procedure he suffered heart blockage.  For treating heart blockage permanent pacemaker implantation was required.  Procedure for PPI (permanent pacemaker implantation) was performed on 26.12.2002.  He was then discharged on 28.12.2002.  His wife however reached OP1 Hospital at 9.30 pm on 26.12.2002 whereas he was operated upon for PPI at about 10.30 am on 26.12.2002.  Complainant was discharged on 28.12.2002.  He again visited OP1 Hospital on 02.01.2003 when his stitches were removed.  He experienced discomfort on 10.01.2003 when there was vibration of chest muscles accompanied by irregular heart beat.  He contacted OP2 in Delhi over telephone.  A reprogramming of the pacemaker was done on 15.01.2003.  Another such reprogramming was done on 18.01.2003.  Again complainant visited OP1 Hospital on 08.02.2003 when piercing of the lead of the pacemaker in the heart was noticed.  Open heart surgery was performed on the complainant on 11.02.2003.  Lead which was piercing the heart, was pulled out.  Hole made in the heart by the lead of the pacemaker was stitched.  He was discharged on 19.02.2003.  The second problem thus that arose in the case was piercing of the heart by the lead of the pacemaker. 

 

20. We have the experts’ opinion before us.  In reply to question No. 3 the experts stated that there is a risk of blocking main conduction pathway during RFA if the accessory pathway is close to the main conduction pathway.  Coming to the second problem experts opined that lead perforation though uncommon complication was reported in 03 patients out of <2500. 

 

21. There is no material placed on record by the complainant to upset the experts’ opinion and accept the contention that both these problems took place due to negligence on the part of the treating doctors.

 

22. Now the next question that arises for consideration is whether the patient was explained the risk of RFA specially heart block before starting with the procedure.  Before examining this question let us have a look at the law relating to ‘consent’ or ‘informed consent’ in writing as laid down by the superior courts.  Hon’ble National Commission in the case of Sulochana Lad vs. Dr. Mohan Gerra & Anr., IV (2016) CPJ 505 (NC), discussed the concept of “informed consent”.  Paras 21, 22 & 26 of the judgement are relevant.  The same 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.”

 

 

23. Reverting to the case in hand, OPs placed on record a consent form dated 23.12.2002 showing the consent having been taken for EPS.  The contents of this form have been discussed above.  It is the admitted case of the parties that after electro physiology study (EPS), Radio Frequency Ablation is done.  In other words this a diagnostic as well as therapeutic procedure.  As opined by the experts in case risk of RFA procedure following the EPS study is higher than anticipated it is to be discussed again the with patient when he is conscious.  In the present case EPS study clearly showed that the accessory pathway was close to the main conduction pathway.  There definitely was a risk of blocking of the heart.  No such information was given to the patient after the treating doctors noticed the closeness of the accessory pathway and the main conduction pathway.  Clearly, the patient was conscious at that time.  Doctors also did not find it necessary to ask the patient to call his relatives/ attendants so as to explain the risks of the procedure.  Patient was never told the seriousness of the procedure.  He could call his wife only when he had suffered the problem.  Be that as it may, consent form dated 23.12.2002 does not disclose the risk of blocking of the heart in doing ablation  when the accessory pathway is close to the main conduction pathway.  The language used in the said consent form is highly deceptive in that it does not clearly spell out that the procedure is both diagnostic and therapeutic.  It simply uses the words “medical/ diagnostic procedure”.  The words “EPS” are not accompanied by the words “RFA”.  In the absence of the words 'RFA’ it is not indicated that ablation is included in the procedure. 

 

24. Another consent form dated 24.12.2002 is a verbatim copy of the consent form dated 23.12.2002.  OPs failed to indicate to the patient that now they were going for another treatment.  Consent form dated 24.12.2002 also mentions only EPS procedure.  There is a third consent form which is again dated 24.12.2002 but in the column of procedure it reads “for – PPI”.  Shockingly this form as well is also a verbatim copy of the earlier two forms.  It does not disclose to the patient that permanent pacemaker implantation was being done on him.  There is fourth consent form which is dated 11.02.2003 showing in the column of procedure, “Thoracotomy”.  Again this form is a verbatim copy of earlier three forms.  It does not disclose to the patient or his relatives/ attendants that an open surgery was going to be performed on the patient.  In a mechanical manner the OP1 Hospital used one consent form without disclosing the different kinds of risks involved.  The complainant and his relatives/ attendants remained in dark all along. 

 

25. As referred to above, in this Commission’s orders dated 10.02.2012, OP1 hospital failed to place on record ECG traces report as called for by the experts.  Nothing has been placed on record by the OP1 Hospital to show that the same was ever handed over to the patient or his relatives/ attendants.  It goes to show that the OP1 Hospital has something to conceal from the world.  An adverse inference therefore, has to be drawn against it.

 

26. In view of the reasons given above, the OP1 Hospital was clearly ‘deficient in service’.  Complainant was put to the procedure without enlightening him on the subject.  OP1 hospital is, therefore, directed to compensate the complainants (now his successors in interest) for the aforesaid ‘deficiency in service’ by paying compensation to the tune of Rs.10 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 30 days from today failing which the amount shall carry an interest @12% per annum.  Complaint is accordingly disposed of.  File be consigned to records.

 

                                 

(N P KAUSHIK)

MEMBER (JUDICIAL)

13.