Pacemaker Implantation under co morbid conditions
CONSUMER CASE NO. 1934 OF 2018
JAGDISH K. SHARMA
Versus
MEDANTA, THE MEDICITY
Decided by the Hon’ble NCDRC, NEW DELHI on 14.05.2024.
FACTS: On 04.07.2016 at 1603 hrs, as advised by Dr. Balbir Singh (Opposite Party No. 3), the patient was admitted at Medanta, The Medicity (Opposite Party No. 2) for planned and Elective Procedure of Pacemaker Implantation. After detailed examination, no abnormality on the patient was detected by the doctor and the nurse on duty. The medical history of the patient that she was a high-risk case for development of a stroke and was on Pradaxa 150 mg twice per day was informed to the Opposite Party No. 3, considering which, the Opposite Party No. 3 had kept the patient off Pradaxa for 48 hours. On 05.07.2016 at 2.58 pm, the patient underwent Pacemaker Implantation at Opposite Party No. 2. On 06.07.2018, it was informed to the Complainant No. 1 that the patient was under medical supervision in Cardiology ICU and would be discharged on the same day after the Complainant No. 1 cleared the bills. It was alleged that upon arrival at Medanta Hospital, the Complainant No. 1 was denied access to the Cardiology ICU to see his wife unless he cleared the bills first. Hours later, when finally granted entry, he found his wife in the ICU unconscious and unattended, suffering from a life-threatening stroke. Being a Cardiologist himself, he had to intervene to provide emergency care instructions and the delay in treatment due to hospital negligence resulted in severe consequences for his wife, including paralysis. It was further alleged that the hospital’s failure to restart the patient’s medication i.e. Pradaxa much earlier after surgery and the irresponsible conduct of the Opposite Parties towards the patient further aggravated the situation due to which, the patient suffered a stroke leading to paralysis. On 08.07.2016, ultimately, the patient was discharged. Despite complaints to the Hospital administration, including a letter to Dr. Naresh Trehan, Chairman & MD, no satisfactory response was received. It was further alleged that due to unhygienic conditions in the hospital, the patient developed pacemaker infection on 29.07.2016. On meetings of the Complainant No. 1 with Dr. Naresh Trehan, Chairman and MD and the Medical Superintendent of the Hospital, they denied any negligence on the part of their Doctors or Hospital. Alleging medical negligence causing stroke and ultimately paralysis to the patient, the Complainants filed the Consumer Complaint seeking total compensation to the tune of Rs. 2,78,24,904/- with interest at the rate of 12% p.a. from the date of Complaint till realization.
DEFENSE: The stroke suffered by the patient on 06.07.2016 was the fourth stroke suffered by the patient, which was attended to very swiftly and the damage caused to the patient was not due to the stroke. The Complainant No. 1 being a Cardiologist himself, a detailed discussion regarding the pacemaker implantation including the management of Pradaxa was conducted. It was also informed to the Complainants that the patient being a known case of recurrent stroke, Tab. Pradaxa will be temporarily discontinued and will be started after 24 hours of the conduct of the procedure. On the date of pacemaker implantation, pre-operative relevant blood investigations were conducted which reported the patient fit and normal to undergo implantation. The Single Chamber Pacemaker implantation was conducted by the Opposite Party No. 3, which was uncomplicated. Post-operative protocol was followed to manage the patient. Chest X-ray and ECG were conducted, which showed normal report post-operation. On 06.07.2016, in the morning, the patient was conscious and was examined. She was showing expected improvements. As per protocol at 1.00 pm, Tab. Pradaxa, which was on hold for 24 hours of the procedure, was administered. However, at around 3.10pm, when the discharge formalities were completed, the patient suffered a sudden stroke, in response to which, CT Brain Plain and CT Angio Brain and Neck was conducted on urgent basis, the findings of which revealed that the stroke to the patient in 2014 and January, 2016 had caused damage to the brain. It was also suggestive of the fact that the patient was prone to atherosclerosis and such significant stenosis at such an aggressive rate cannot be solely due to temporary discontinuation of Tab. Pradaxa for a very limited period. An informed consent was given by the Complainant No. 1 at 3.50pm for procedure of endovascular mechanical thrombectomy on the patient to prevent major infarct. The patient underwent a successful procedure by 5.30pm. The patient was, thereafter, shifted to ICU for continued monitoring. Tab. Pradaxa was advised to start. On 07.07.2016, finding the patient conscious and oriented and after getting the required examination, she was shifted to a room and she completely recovered from the stroke. On 08.07.2016, the patient was discharged from the Hospital in a stable condition with follow-up advice. It was stated that except on 14.07.2016, the Complainants, thereafter, did not come-up for further follow up.
TERMS OF REFERENCE TO EXPERT TEAM OF AIIMS, NEW DELHI: whether there was any negligence by the hospital and the treating doctors on account of:
a. delayed administering of Pradaxa, which would have avoided the stroke;
b. whether the ICU staff should have been more attentive in attending to the patient; and
c. or any other point, which the Expert Committee may find on the part of the Opposite Parties, which might be construed as negligence on their part.”
Expert Opinion of AIIMS: There was no medical negligence on the part of the hospital and the treating team.
“The medical board is of opinion that there was no medical negligence by the hospital or treating team. In response to the specific questions asked:
a. There was no delay in administering Pradaxa after the permanent pacemaker implantation.
b. According to the available hospital records and timelines the response of the ICU staff and treating team was optimal.
c. None.”
HELD: Considering that the main argument of the learned Counsel for the Complainants that the administration of Pradaxa or rather non-administration and the same not having been found to be relevant leading to the unfortunate stroke suffered by the patient as per the Expert Report, I do not see any further observation by me in this regard and therefore to this extent, the argument of the Complainants fails. The second argument of the learned Counsel for the Complainants was about the poor post-operative care in the ICU. It is the fact that the patient did suffer a stroke while she was at the stage of being discharged from the ICU of the hospital. The Complainants have submitted that there was no prompt action taken to prevent such an episode. However, on perusal of the record, it is seen that there was prompt action taken by the staff and the doctors in shifting the patient to the Cardiac Cath Lab, where she underwent mechanical thrombectomy and was discharged two days later on 08.07.2018. I understand the anxiety of the Complainant No. 1, who is the husband of the Complainant No. 2 and who himself is a Cardiologist. On reading the Complaint, it becomes very evident and at times he could not control himself from giving directions to the hospital staff / doctors. It is not the case of the Complainant No. 1 that the Doctors at the hospital were really incompetent as he himself had chosen the hospital after due care and the patient had even earlier been admitted in the hospital for certain interventions, which was done to the satisfaction of the Complainant No. 1. It has to be kept in mind that once the patient is admitted to the hospital, it should be left to the treating doctors to decide on the process and procedure of treatment and also give certain space to them in performing their duties. No doubt, the Complainant No. 1 is a Cardiologist, however, interfering with the treatment and casting doubt on the treating doctors, in my opinion, after going through the record is not warranted and appears to be an over-reaction. It is unfortunate that the patient suffered a cardiac stroke and had to suffer thereafter. However, there is no proof of correlation shown in the Complaint or argued that the cardiac arrest was the result of the implantation of the pacemaker. Since the patient was a chronic heart patient and having gone through various interventions in the past, the probability of such a stroke cannot be ruled out. It is to the credit of the hospital that prompt action post-stroke was taken and the patient survived. In view of the aforesaid discussion, I do not find any medical negligence on the part of the Opposite Parties. Accordingly, the Complaint is dismissed.
