Complaint filed on: 08-02-2023.

                                                      Disposed on: 16-08-2023

BEFORE THE DISTRICT CONSUMER DISPUTES

REDRESSAL COMMISSION, TUMAKURU

DATED THIS THE 16^th DAY OF AUGUST, 2023

PRESENT

SMT.G.T.VIJAYALAKSHMI, B.Com., LLM., PRESIDENT

SRI.KUMARA.N, B.Sc. (Agri), LLB., MBA., MEMBER

SMT.NIVEDITA RAVISH, B.A., LLB. (Spl)., LADY MEMBER

CC.No.15/2023

Sri. C.Gangadaraiah

S/o Late C.Chikkabasavaiah,

A/a 65 years, Yellapura, Tumkur Kasaba,

Tumkur Taluk,

……………….Complainant/s

(In person)

                                                V/s

1.       Sri. Dr.Parameshwar, Managing Direcotr,

          Siddaganga Hospital & Research Center,

          B.H.Road, Tumakuru.

2.       Sri. Dr.Sharathkumar J.V. M.B.B.S.,

          M.D.D.N.D., Cardiology,

          Medical Officier, Siddaganga Hospital,

          B.H.Road, Tumakuru.

3.       Dr.Banuprakash, HM Prakash, M.B.B.S,

          M.D. Siddaganga Hospital, B.H.Road,

          Tumkauru.

……………….Opposite Party/s

(By Sri.H.B.Gurukiran, Adv.,)

: O R D E R :

BY SRI.KUMARA.N., MEMBER

This complaint was filed by the complainant U/s 35 of the Consumer Protection Act 2019 to direct the OPs to pay Rs.3,50,000/- paid towards pacemaker implantation, Rs.59,000/- and Rs.1,35,000/- paid to Jayadeva Hospital, Bangalore towards implantation for new pacemaker as his pacemaker adopted by OP was not functioning and further prays to direct the OPs to pay Rs.10,00,000/- towards mental agony to the complainant.

2.       In this case the Opposite Parties are Sri. Dr.Parameshwar, Managing Director, Siddaganga Hospital and Research Centre, B.H.Road, Tumakur, Sri. Dr.Sharath Kumar G.V., M.B.B.S., M.D.D.N.D, Cardiology, Medical Officer, Siddaganga Hospital, B.H.Road, Tumakur andDr.Banujayaprakash, H.M. Prakash, M.B.B.S, M.D.Siddaganga Hospital, B.H.Road, Tumkur (hereinafter called as “OP No.1, 2 & 3 respectively) 

3. Its, a case of complaint, that the complainant approached the OPs/ OP Hospital to take treatment for his cardiac problems, as advised by the OPs, the complainant on 17.10.2022 admitted to the OP’s Hospital as a inpatient and after the different tests conducted, on the same day, the OPs operated and inserted the pacemaker on the left chest of the complainant and discharged on 20.10.2022.  The complainant paid total amount of Rs.3,50,000/- to the OPs, towards treatment charges. As per the instructions of OPs, the complainant after the few days of discharge, on 15.12.2022. visited the OPs for routine check-up, the complainant shocked, after hearing from OPs, that the inserted pacemaker got infected and advised the complainant, that treatment is to replace with the new pacemaker and the complainant has to pay treatment charges and cost of new pacemaker.  The complainant requested the OPs to pay back the amount paid earlier, but the OPs denied. Later, the OP’s Doctor written letter to Jayadeva hospital Bangalore and referred the complainant to the Jayadeva Hospital, Bangalore and advised to take further treatment.  The complainant on 15.12.2022, approached the Jayadeva Hospital, Bangalore and the Doctor after the checkup, diagnosed and informed the complainant, that the pacemaker implanted earlier infected, which is due to negligence of the Doctors of Siddaganga Hospital, Tumakuru, i.e. (OPs) and the complainant, admitted to the Jayadeva hospital Bangalore as inpatient, after the several tests, on 20-12-2023, temporary pacemaker implanted to the complainant right side of the chest by removing infected pacemaker implanted on left side chest of the complainant, after the five days of treatment the complainant discharged and advised to readmission on 03-01-2023, accordingly the complainant admitted as an inpatient, and on 07-01-2023, permanent pacemaker implanted by removing the temporary pacemaker, and on 11-01-2023 discharged with instructions and prescription of medicines. The Jayadeva hospital Bangalore charged, Rs 59000.00 and Rs 135814.00 towards temporary pacemaker & permanent pacemaker implantation and other treatment charges to the complainant, accordingly the complainant paid the amount. The complainant, after treatment, in Jayadeva hospital Bangalore, living happily and leading healthy life, without any problem.  The complainant submitted that due to the negligence act of the OPs, made the complainant to suffer, hence, this complaint.
4.        After the complaint registered, Commission notice was served to the OPs, in-turn the OPs appeared through their counsel and filed version contending that the, averments made in the complaint paras are all emphatically denied as false, the complainant narrated false and concocted story to make unlawful gain and admitted the facts, that the complainant admitted to the OP’s hospital, as the complainant suffering from diabetes and hypertension with the symptomatic 2:1 av block for which the treatment was permanent pacemaker implantation.  Accordingly, the complainant admitted to the OP’s Hospital as an inpatient on 17.10.2022 and after the tests conducted, permanent pacemaker was inserted to the complainant and discharged on 20.10.2022 and at the time of discharge wound healed and sutures were removed.  It is further submitted, that after two months of discharge, the complainant approached for routine check-up and it was noticed that pacemaker got infected, for which the treatment is removal of the old device and insertion of new device on the left side of the complainant body and same was explained to the complainant and his son, but the complainant refused to take treatment, as he wants to take treatment in some other institution. The OPs denied other averments in the complaint and prays to dismiss the complaint against them..     

5.        The complainant has filed his affidavit evidence and marked the documents at Ex.P1 to P16.  Dr.S.Paramesh, Managing Director of OPs has filed his affidavit evidence on behalf of OPs.  The OPs have marked the documents at Ex.R1 to R5. 

6. .       We have heard the arguments of complainant in person and counsel for OPs.  The complainant in person also files written arguments.

7.       The points that would arise for our consideration are:-

1. Whether the complainant proves the negligence acts of OPs?

2. Is complainant entitled to the reliefs sought for?

8.       Our findings on the aforesaid points are as follows:

Point No.1: In the Partly Affirmative

Point No.2: As per below order

:R E A S O N S:

Point Nos.(1) & (2):-

9. The complainant, in person argued that, he approached the OPs for treatment of his heart problem, as advised by OPs, believed the OPs blindly and he admitted to the OPs hospital on 17.10.2022, after the different tests conducted, on the same day, the OPs operated and inserted the pacemaker on the left chest of the complainant and discharged on 20.10.2022.  The OPs charged and collected Rs.3,50,000/- from the complainant. The complainant submitted that, the OPs not given the variants of pacemakers available and other details of the pacemaker and its maintenance to the complainant. The complainant approached the OPs on 15.12.2022 for routine check-up, the complainant shocked that the inserted pacemaker got infected and OPs advised to replace with the new pacemaker, for that, the complainant has to pay applicable charges and pacemaker cost.  The complainant requested the OPs to pay back the amount paid earlier, but the OPs denied.  Later, the OP’s Doctor referred the complainant to the Jayadeva Hospital, Bangalore for further treatment.  The complainant on 15-12-2022, approached the Jayadeva Hospital, Bangalore and the Doctors diagnosed and stated that the pacemaker infected due to negligence act of the OPs and after the test, on 20-12-2022, inserted temporary pacemaker and given treatment for 5 days and discharged the complainant with instructions and charged Rs.59,000/-, and advised the complainant to visit on 03-01-2023, accordingly the complainant, admitted further as inpatient, after the several tests, on 07-01-2023, permanent pacemaker inserted by removing the temporary pacemaker and after the treatment on 11-01-2023 the complainant discharged with prescriptions and instructions and charged Rs 135914.00, and now the complainant living happily.  The complainant alleged that, the OPs without proper care, inserted the permanent pacemaker on the day of admission, i.e. 17-10-2022, due to negligence act of OPs the complainant suffered, and the OPs not provided details of pacemaker inserted and its maintenance after the discharge, the OPs just advised to do follow after one week in cardiology opd.  Hence the complainant prays to allow the complaint and award compensation. The complainant produced documents,ExP1, copy of OPs letter to Jayadeva hospital Bangalore, ExP2 & P3, copies of discharge summery of OPs hospital, Ex P4, ExP5,ExP6, ExP6, ExP7, ExP8, ExP9 & ExP10, copies of impatient detailed bill of a complainant for Rs 350000.00, ExP11, copy of Discharge summery of Jayadeva hospital, Bangalore, ExP12, copy of Pulse generator extraction report, ExP13, copy of inpatient bill for Rs 59005.00, ExP14, copy of discharge summery & pacemaker implantation report of Jayadeva hospital Bangalore, ExP15, copy of Inpatient bill of a complainant for Rs 135814.00 and Ex P16, photos.

10.     The OPs counsel argued that, the complainant suffering from diabetes and hypertension with the symptomatic 2:1 av block for which the treatment was, permanent pacemaker implantation, accordingly, the complainant admitted to the OP’s Hospital as an inpatient on 17.10.2022 and after the tests conducted, pacemaker was inserted to the complainant and discharged on 20.10.2022 and at the time of discharge would healed and sutures were removed. When the complainant approached on for routine checkup, it’s noticed that, pacemaker infected, the treatment is replacement of the new device, as the complainant want to take treatment in other institution, with instructions the complainant referred to the Jayadeva hospital Bangalore. The treated Doctors (OP No 2 & 3) submitted that, pacemaker infection, it’s a common problem in pacemaker insertion in India, it’s not due to negligence acts of doctors and produced documents (Copy of research articles published) ExR1, copy of pocket hematoma and CIED infection, ExR2, copy of Cardiac device related infection (May 2017), ExR3, copy of Risk of cardiac pacemaker pocket infection in a tertiary care hospital and Ex R4, copy of Infection summit.

11.     A pacemaker refers to a small device that consists of two parts. There is a generator and wires that are placed under the skin of one’s chest for controlling the heartbeat. Doctors suggest a pacemaker for various reasons – majorly due to conditions such as arrhythmias where the heart rhythm is abnormal. Their major role is to control your heartbeat. They can be temporarily implanted for treating a slow heartbeat after an attack, overdose of medication or surgery. They are also implanted permanently to slow down the heartbeat or to treat heart failure.

Types of Pacemakers; There are three types of pacemakers that are mentioned below:

• Single Chamber Pacemaker; This refers to a pacemaker that carries electrical impulses from pulse generator and takes it to the right ventricle of your heart.

• Dual Chamber Pacemaker; This one carries electrical impulses from pulse generator to both the right atrium and right ventricle of your heart. The role of the impulses is to monitor the timing of contractions between the two chambers.

• Biventricular Pacemaker; This is recommended to people who have had a heart failure and their heart’s electrical systems demand repairing. Unlike a normal pacemaker, this one stimulates both the lowers chambers, thereby making the heartbeat more efficiently. It resets the pumping mechanism of the ventricles and therefore is also referred to as cardiac resynchronization therapy.

Following are tests carried out to recommend if the pacemaker implantation is needed.

• Electrocardiogram (EKG); This one is a painless and simple test that is done to detect and record the electrical activity of your heart. It shows how fast he heart is beating and how steady or irregular is the rhythm. This also records the timing and strength of the signals as they transmit through the heart.

• Holter and Event Monitors; It records your heart’s electrical activity for 24 or48 hours. One has to wear it while carrying on with his/her regular activities. It allows one to monitor the heart for a longer time than a standard EKG. For many of the event monitors, one has to push the start button whenever he/she feels the symptoms. Other event monitors automatically start the event monitors when they sense some abnormal heart rhythm.

• Echocardiography; This involves usage of sound waves to create a moving picture of your heart. It shows the shape and size of your heart and concludes how well is your heart chamber and valve working. It also points to the areas where there is poor blood flow, muscles that aren’t contracting normally, or injury to the muscle caused by poor blood flow.

• Electrophysiology Study; This involves passing a thin and flexible wire through your vein in your upper thigh or arm to your heart. It records your heart’s electrical signals.

• Stress Test; This involves exercising to make your heart work and beat faster while other heart tests like echo or EKG are done. If some people find it difficult to exercise, medicines are given, to increase heart rate.

Pacemaker Implantation Procedure; It is implanted in two ways–

• Endocardial approach;   It is the most common technique used. It is performed in a electrophysiology or pacemaker lab. A local anaesthesia is given to numb the area. This is followed by an incision in the chest where the pacemaker and leads are inserted. The lead is inserted through an incision to the vein and then guided through heart with the help of a fluoroscopy machine. The lead tip attaches itself to the heart muscle while the other end of the lead is placed in a pocket that is created under the skin in the upper part of the chest.

• Epicardial Approach ; This is carried out by any surgeon in a surgical suite and initiated with a general anaesthesia that puts you to sleep. Surgeon attaches the lead tip to the heart muscle and the other part pf the lead is placed in the pocket thereby creating a pocket under the skin of the abdomen. Recovery from this is longer than other approach, but minimally invasive techniques allow shorter hospital stays and quicker recoveries.

After Pacemaker Implantation cares to be taken

• Electric blankets, microwave ovens and heating pads can be used as they do not interfere with the function of your pacemaker implantation

• It is suggested to keep the cell phone on the other side of where the pacemaker was implanted.

• It is recommended to avoid strong electromagnetic fields such as high intensity radio waves which are fund near power plants or electrical generators. You can also stay away from arc resistance welders

• It is suggested not to undergo tests that demand magnetic resonance imaging

• Usually a complete pacemaker check is required post six weeks after the implantation. Adjustments are made after discussions with the doctor and how the recovery happens. The treatment for a pacemaker is usually invasive but still requires care.

12. PREPARE FOR PACEMAKER SURGERY; Especially in cases of temporary pacemaker insertion, no preparation is done by the patient, and it is immediately executed by doctors in a medical setting as it is an emergency situation, either in order for a permanent pacemaker placement later, or to be removed later in expectation of a steady heart rhythm after successful completion of the procedure.

If a permanent pacemaker is to be implanted, the doctor offers a complete checklist of things to be done and to be avoided by the patient in preparation for surgery after going through a detailed medical history of the individual. Pacemaker risks remain low, and the preparatory steps are usually uncomplicated and may include:

• Not eating or drinking for eight hours before the surgery. This stabilizes the blood pressure in most cases, lowering pacemaker risks further.

• Using a special soap to disinfect the area of the body where the pacemaker surgery will happen.

• Starting or stopping medication may be recommended by a doctor, depending upon patient body's pathophysiology. Medicines that may interfere with pacemaker operation by heightening or subduing blood pressure may be monitored or stopped completely, and other medication to help the blood circulate more easily may be recommended.

Tests to be performed prior to pacemaker surgery include:

• Electrocardiogram (ECG) test: To understand your heart's impulse generation condition.

• Echocardiogram: Involves sound wave reflection to determine the heartbeat and provide the best pacemaker solution for your body
• Holter monitoring is done in case the erratic heartbeat occurs outside the hospital, and involves the patient wearing the monitor outside the hospital so that abnormal heart rhythms can be picked up throughout the day, and all abnormalities reported.

• Pacemaker precautions can include a stress test which is a commonly used test to determine heart and blood pressure conditions. An ECG is performed during exercise to determine if the pacemaker implantation is to correct erratic heartbeat only during heightened activity levels.

Temporary Pacemaker: A temporary pacemaker is always inserted under medical observation and the pacemaker operation happens under controlled clinical conditions when the patient's requirement for an artificial pacemaker is understood to be temporary and the dysrhythmia is to be resolved soon after. A temporary pacemaker may also be implanted before a permanent one is provided.  

    (Different Brands of Pacemaker in India; Medtronic, Abbott, Boston Scientific and Biotronik manufacture the leading pacemaker brands in India. In India, pacemakers cost between ₹1 lakh to ₹9 lakh, with batteries that last on average between 7-10 years.

14.     Section 2(47) of the Consumer Protection Act, 2019 defines the term 'unfair trade practices' which include: Manufacturing spurious goods or providing defective services

15.     The discharge summary is a narrative document for communicating clinical information about what happened to the patient in the hospital. It’s extremely important for telling primary care doctors and other outpatient providers which follow-ups are needed for the patient. Discharge summary is provided to the patients at the time of discharge, its  contains the patient's name, unique identification number, name of the treating Doctor, date of admission and date of discharge, the reasons for admission, significant findings and diagnosis and the patient's condition at the time of discharge, information regarding investigation results, any procedure performed, medication administered, and other treatment given, follow-up advice, medication and other instructions in an understandable manner, but in this case, in the complainant discharge summery, information regarding investigation results, procedure performed, medication administered, for the permanent pacemaker implantation not recorded and explained, which leads to deficiency on the part of OPs.

16.     Research Article, A study on pacemaker pocket infection by: Goutam Datta, MD.DNB.DM.MRCP(UK), Associate Professor, Burdwan Medical College, Calcutta,–33,India ( Published on 25 March 2020,in Journal of Cardiology and Cardiovascular Medicine), concluded as, Pacemaker pocket infections is a dreaded complication after pacemaker implantation. During implantation, there is a risk of device contamination with the patient’s own skin flora, introduced into the wound at the time of skin incision and it can be prevented by ideal surgical asepsis technique, pre and perioperative use of antibiotics.

17.     In this case, the complainant admitted to the OPs hospital on 17-10-2022 as a inpatient, as he was suffering from diabetes and hypertension with the symptomatic 2:1 av block, after the diagnosed and the different tests conducted, permanent pacemaker implanted to the complainant on 17-10-2022, and after the treatment, the complainant discharged on 20-10-2022, is an admitted facts, not disputed.

18.     As alleged by the complainant, that the negligence acts of OPs, caused pacemaker infection and made the complainant to suffer and the complainant, blindly believed the OPs and the OPs charged Rs 350006.00 towards treatment and the complainant paid Rs 350006.00 to the OPs and the OPs without explaining the different variants of pacemakers available in the market, for their convince, they implanted the pacemaker which was available with them, and even after the pacemaker implanted, the OPs not given the details of pacemaker implanted and its instructions on maintenance, on perusal of the Discharge summery  (Ex P2 & Ex P3), in the heading surgery and review, mentioned as CAG on 17-10-2022 and follow-up after one week in cardiology OPD. CAG is Coronary artery angiography, which are important procedures for the diagnosis and treatment of patients with coronary artery disease. But, nowhere in the OPs, discharge summery (State Consumer Disputes Redressal Commission, GUJARAT STATE, AHMEDABAD. Appeal No. 1415 of 2014, on 21 October, 2021 in the case of K V Ramani vs Sterling Hospital & Others ), details of pacemaker, and pacemaker implantation procedure followed, Indication, Access, pocket type, pulse generator lead, procedure, Implant data advice, not given nor recorded, but only in the inpatient detailed bill (ExP4 to 10), mentioned as, Rs 250000.00 and Rs 21875.00 towards pacemaker cost and implantation charges, which leads to 'unfair trade practices' of OPs and negligence on the part of OPs.

19.  The defense of OPs, i.e. pacemaker’s infection is a common and the success rate is low, which was explained to the complainant before pacemaker implantation, not considered by relying on the, Para 16, and the OPs in their version not specifically taken defense on pacemaker infection and the negligence acts, by considering Order 8 Rule 5 of the C.P.C. which, provides that, unless there is a specific denial of any allegation of fact made in the plaint, it shall be taken to be admitted,

20.     Doctor owes to his patient certain duties which are (a) a duty of care in deciding whether to undertake the case; (b) a duty of care in deciding what treatment to give; and (c) a duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his Doctor.” In this case the OPs failed to fulfill these requirements in the instant case. The OPs not provided the details of pacemaker implanted and its care and maintenance to the complainant and collected Rs 250000.00 and Rs 21875.00, even not recorded in his discharge summery which is an, important medical record, which leads to 'unfair trade practices'. Therefore, by relying on (para 16) Research Article, A study on pacemaker pocket infection by: Goutam Datta, MD.DNB.DM.MRCP(UK), Associate Professor, Burdwan Medical College, Calcutta,–33,India ( Published on 25 March 2020,in Journal of Cardiology and Cardiovascular Medicine), we are of the opinion that OPs implanted pacemaker in negligent manner resulted in pacemaker’s infection. In case proper procedure and proper post care would have been taken by the OPs, the complainant would have not suffered. Therefore, we conclude that Op No. 2 and 3 is negligent in conducting the procedure for implantation of the pacemaker and post operative care whereas Op No. 1 being the hospital head or CEO is vicariously liable. The complainant prays to award Rs 10,00,000.00 towards mental agony, but to substantiate, proper evidences not produced by the complainant. The OPs are played with the health of the complainant.  For the acts of OPs, the complainant suffered and undergone further treatment (i.e. Pacemaker implantation) in Jayadeva Hospital, Bangalore by spending Rs.1,94,819-00 [(Ex.P13 and Ex.P15) (Rs.1,35,814-00 + Rs.59,005-00 = Rs.1,94,819-00)], by considering the above discussions, this commission is in the opinion of, the OPs are liable to Pay Rs. 1,94,819-00 incurred at Jayadeva Hospital, Bangalore along with interest @ 9% PA from the date of discharge i.e. 11.01.2023 to till realization to the complainant and also liable to pay punitive damages of Rs.25,000-00.  The OPs compelled the complainant to approach this commission, hence OPs are liable to pay the litigation cost of Rs.10,000-00.  Accordingly we proceed to pass the order as;

:O R D E R:

Complaint filed by the complainant is allowed in part.

The OPs are ordered to pay, jointly and severely              Rs.1,94,819.00 (Rs.One Lakh Ninety Four Thousand Eight Hundred and Nineteen only) along with interest @ 9.00 % p.a from the date of discharge i.e. 11-01-2023 to till realization to the complainant. It is further ordered that OPs jointly and severally to pay Rs.25,000-00 (Rs.Twenty Five Thousand only) towards punitive damages and          Rs.10,000-00 (Rs.Ten Thousand Only) towards litigation expenses to the complainant.

The OPs are further jointly and severally directed to comply the above order within 45 days from the date of receipt/knowledge of the order, otherwise, it carries fine of 200.00 (Rs.Two Hundred only) per day till realization.

Furnish the copy of order to the complainant and opposite party at free of cost.