Clipped from: https://www.business-standard.com/article/opinion/hospital-held-liable-for-acting-without-consent-123021900819_1.html
Dilip filed a complaint before the Delhi State Commission, alleging that the RFA procedure was carried out without his knowledge or consent, and also without considering the findings of the EPS
Dilip Kumar Goswami was suffering from Wolff-Parkinson White Syndrome, which results in palpitation, medically termed as paroxysmal supraventricular tachycardia (PSVT). He was admitted to Batra Hospital and Medical Research Centre in Delhi, where he underwent electrophysiology study (EPS) along with radiofrequency ablation (RFA) on December 23, 2002.
A heart block occurred during this procedure, so a temporary pacemaker was installed. Later, a permanent double chamber pacemaker was installed during a separate operation performed on December 26, 2002. Within a few months, the permanent pacemaker malfunctioned, necessitating another surgery on February 11, 2003, for implantation of a new lead to make the pacemaker functional once again.
Dilip filed a complaint before the Delhi State Commission, alleging that the RFA procedure was carried out without his knowledge or consent, and also without considering the findings of the EPS. He stated that RFA was performed even though less risky procedures were available. This led to heart blockage, necessitating implants and further surgeries.
The state commission referred the dispute to Maulana Azad Medical College for expert opinion. The latter constituted a board of doctors. In its March 23, 2012 report, the board observed that the documentation provided regarding EPS, ECG and RFA was not adequate. The hospital had furnished a fluoroscopic image instead of EPS traces. However, the board concluded that there was no negligence on the part of Batra Hospital or its doctors.
The State Commission observed that the suppression of the EPS and EEG strips by the hospital indicated that it was attempting to conceal certain facts. The state commission noted the expert committee’s opinion that RFA procedure after EPS is riskier as it can lead to a blockage in the heart. However, this risk was not communicated while obtaining consent. The commission also deprecated the deceptive language used in wording the consent. In the first consent obtained on December 23, 2002, EPS was mentioned as a medical diagnostic procedure. However, RFA was not mentioned as a therapeutic procedure.
The consent for the second procedure on December 26, 2002, was a replica of the previous consent. There was no mention of the fact that a permanent pacemaker would be implanted. The subsequent consent form for the procedure on February 11, 2003, was also a replica of the previous consent forms. The procedure of thoracotomy was not added. That an open-heart surgery would be performed was not disclosed. The commission concluded that one standard consent form was mechanically used for all the procedures without disclosing the different kinds of risks involved. It indicted the hospital for keeping the patient and his family members uninformed. The state commission concluded that the acts of suppressing the ECG strips and conducting procedures without valid informed consent amounted to deficiency in service and unfair trade practice. It held the hospital liable to pay Rs 10 lakh as compensation along with 7 per cent interest. The doctors were, however, not held liable.
Batra Hospital appealed against the order, contending that the award of compensation was not justified when there was no negligence on the doctors’ part.
The National Commission reappraised the evidence. It observed that the consent form did not even bear the signature of the doctor who had obtained the patient’s signature.
By its order of February 7, 2023 delivered by a Bench of Dinesh Singh and Karuna Nand Bajpayee, the National Commission concluded that the acts of suppressing the ECG strips and conducting procedures without valid informed consent amounted to deficiency in service and unfair trade practice. It concurred with the State Commission’s decision and dismissed Batra Hospital’s appeal. Since Dilip had expired by then, the Commission ordered that the compensation be paid to his widow, Jyoti Bezbarua Goswami.
The writer is a consumer activist