New Delhi: Observing that the patient was not enlightened about the risks and complications of the cardiology procedures that were performed on him; the Delhi State Consumer Redressal Commission has directed Batra Hospital and Medical Research to pay Rs 10 lakh compensation.
The case goes back to the year 2002, when the patient, Dilip Kumar Goswami visited Batra Hospital & Medical Research Centre, suspected with WPW syndrome.
At the said hospital, cardiologist Dr Kaul examined him and informed that he was a known case of Paroxysmal Supraventricular Tachycardia (PSVT). He was told that he required to undergo Electro Physiology Study (EPS) and Radio Frequency Ablation (RFA) in order to detect the syndrome.
Accordingly, the patient underwent EPS and then RFA after which due to some complications, PPI (Permanent Pacemaker Implantation) was performed on him. The implantation was alleged to have led to a piercing, subsequent to which the patient had to undergo open heart surgery.
After his course at the hospital, the patient moved to the consumer court alleging medical negligence on part of the doctors and the hospital. He contended that he was not informed about the risks and complications of the said procedures and all of them were performed without taking his consent.
He further claimed that the doctors did not give him enough time to contact his wife before undergoing the procedures.
Presenting the following grievances before the court, the patient contended:
- RFA was undertaken without disclosing him the report of RFA study.
- The treatment was done without his consent under the guise of EPS.
- Other options for treatment which were less risky and less life-threatening, were not considered before taking up of RFA.
- Negligent treatment of RFA led to heart blockage, further to which he had to undergo pacemaker implantation.
- He was taken to the operation theatre without waiting for the arrival of his wife.
- The implantation was done without care resulting piercing of the heart and his life was put at risk.
- In the end, he had to undergo open heart surgery due to all the aforesaid carelessly conducted procedures.
In their defense, the doctors submitted that the patient developed a rare complication, the occurrences of which were not predictable. As for the consent part, they contended, “Informed and signed consent of the patient was obtained before starting the procedure.”
It is reported that an expert committee consisting of doctors from the Maulana Azad Medical College was formed to examine the case, who after careful perusal stated,
“There is a risk of blocking main conduction pathway during RFA if the accessory pathway is close to the main conduction pathway…lead perforation though uncommon complication was reported in 03 patients out of <2500.”
“There seem to be no negligence from Batra Hospital and/ or attending Doctors anytime during the entire course of treatment and operation of the petitioner,” the committee concluded.
Noting the verdict of the committee, the forum asked for ECG traces report which the hospital failed to provide. The hospital stated that the reports were handed over to the patient along with his discharge papers during his course at the hospital.
While scrutinizing the discharge documents, the court noted, “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.”
The bench of honourable Judge N P Kaushik after going through the committee’s opinion as well as the submissions made by both the parties stated,
“ 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. The 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.”
Noticing that the consent forms were the verbatim copy of each other, the court observed,
“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.”
On this, the court asserted, “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.”
The bench later noted the hospital’s inability to provide the ECG traces report and said,
“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.”
In conclusion, the bench held the hospital was clearly ‘deficient in service’ and stated,
“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 along with interest @7% per annum from the date of institution of the complaint till the date of its realization.”