Not Showing Pacemaker Prior to Implantation Constitutes Deficiency: NCDRC Slaps Rs 2 Lakh Compensation on Gurugram Hospital

New Delhi: Holding that not showing the pacemaker to the patient's attendant before implantation constitutes 'deficiency', the National Consumer Disputes Redressal Commission (NCDRC) recently directed a Gurgaon-based Paras hospital to pay Rs 2 lakh compensation to a man who accused the hospital of deficiency in service while providing treatment to his wife.

While the patient was undergoing treatment at the hospital, the treating doctor implanted a CRT-D pacemaker device. However, the Apex Consumer Court noted that the hospital did not show the said pacemaker to the Complainant before implantation. As per the NCDRC bench, this constituted a deficiency on the part of the hospital. 

The history of the case goes back to 2013 when the complainant's wife was admitted to the treating hospital with complaints of chest congestion, severe coughing, difficulty breathing, uneasiness, and swelling in both legs.  She was diagnosed with acute left ventricular (LV) failure, dilated cardiomyopathy, non-critical coronary artery disease, LV dysfunction with an ejection fraction of 20%, hypothyroidism, and lower respiratory tract infection (LRTI).

The complainant alleged that even though the patient had severe infection and high TLC counts, which persisted until her death on 25.03.2013, the hospital and doctor discharged her with incomplete treatment and advised implantation of a pacemaker device instead of providing necessary medical care. After discharge, the patient lost sensation of urine and was readmitted to the hospital on 11.03.2013.

An MRI test was attempted but could not be completed due to her weakness. The patient suffered cardiac arrest but was revived, placed on a ventilator, and received oxygen support in the CCU, yet continued to suffer from a severe infection affecting her right lung. Thereafter, the doctor obtained consent for a bi-ventricular pacemaker implantation. However, the device was not shown to the complainant. It was alleged that a CRT-D device was implanted despite the patient's poor condition and infection. Thereafter, the patient was transferred to Consultant Internal Medicine Dr. Singh for further care. 

The complainant argued that the pacemaker was unnecessary, and provided no improvement in the patient's heart function and her condition worsened. Later, the patient passed away. The pacemaker was removed post-mortem and handed over to the Complainant after sterilization. It was argued by the complainant that the doctors discussed implanting a CRT-D but instead used an ICD, which is different, ineffective, and possibly expired and infected. He contended that the pacemaker caused the death due to medical negligence. Filing the consumer complaint, he demanded Rs 13 lakh as compensation towards the cost of the pacemaker, installation, and doctor fees.

On the other hand, the hospital informed the District Commission that the complainant was compensated by the insurance company, and the patient received the best possible treatment.

The treating doctor argued that the patient was suffering from severe left ventricular dysfunction with a history of repeated hospitalizations for congestive heart failure and pedal edema. She received decongestive therapy with dobutamine infusion and intravenous diuretics, resulting in improvement. Therefore, a Cardiac resynchronization therapy with a combo (CRT-D) pacemaker was recommended. Angiography was performed and the decision to implant CRT-D was taken after consulting with the Complainant. It was further submitted that the decision on the device depended on the patient's condition and the device was sold before its expiry date.

While considering the matter, the District Commission held that the hospital had provided the device for implantation, which was infected, and caused infection in the patient's body and further deteriorated her health condition. Therefore, the Commission directed the hospital to refund the cost of the CRT-D machine along with interest at the rate of 9% per annum from the date of filing of the complaint till its realization and further pay Rs 25,000 as compensation for mental agony, harassment as well as litigation expenses.

The District Commission's order was challenged before the State Commission by both the hospital and the complainant. However, the State Commission dismissed both the appeals. Thereafter, the hospital approached the NCDRC bench.

While considering the matter, the Apex Consumer Court took note of the fact that the State Commission had considered that this device being implanted was not shown to the Complainant and there was a doubt whether the said device was the same one sold by St. Jude Medical, Cardiac Rhythm. The District Commission also considered the fact that the doctor provided an infected implant causing infection in the patient's body. As she was already in a deteriorated condition, this infection further deteriorated her condition resulting in her death.

Referring to the different legal principles set by the Supreme Court in different judgements including in the case of Jacob Mathew, the NCDRC bench noted that "While such conclusions in respect of the said Pacemaker CRT-D were made, there is no specific evidence or expert opinion on record with respect to the issue in question to challenge the decision to implant a pacemaker; procedure adopted for its implantation; whether the said pacemaker device implanted was infected; and whether such infection resulted in further deterioration of her condition, resulting in her death on 25.03.2013?"

"It is a reasonable presumption that a medical professional would provide treatment that is necessary and in the interest of the patient unless it is established to the contrary. With due regard to her medical condition, including heart condition, the opinion of a specialist was obtained as regards implanting pacemaker CRT-D to the patient on 13.03.2013, after obtaining her consent. By then, she was under acute medical condition and had infections. There is nothing on record to indicate that the said device in question was defective. His allegation that the medical professionals of OP-1 Hospital implanted an infected Pacemaker is also uncorroborated," the Apex Consumer Court further observed.

Considering the facts, the consumer court opined that the allegation of ulterior motive concerning the said pacemaker, it was defective or infected piece and caused further infection to the patient was unsubstantiated.

However, at the same time, the Commission noted that it was undisputed that the said pacemaker, which was of high value and was specially procured for the patient in question, ought to have been shown to the Complainant before the same was unwrapped and implanted as per the medical procedure.

In this regard, the counsel for the petitioner hospital stated that there was no procedure or practice of unwrapping or showing the implants or other such items to the patients or relatives before undertaking the implant procedures. "That was the reason why OP-1 did not notify the same to the Complainant with respect to the implant in question," noted the Commission. 

While the NCDRC bench held that not showing the pacemaker to the complainant was deficiency, it also observed that it could not be concluded that implanting the said CRT-D pacemaker was with ulterior motive or that the pacemaker was infected.

"However, it is expected that such high value critical medical implants are shown to the affected parties before due process. The expectation of the Complainant who was in distress to that extent is fair and that the actions of OP-1 Hospital in not showing the said pacemaker to the Complainant constitute deficiency. At the same time, it cannot be said or concluded that implanting of the said CRT-D pacemaker itself was with ulterior motive or it was infected before it was implanted," observed the Consumer Court.

With this observation, the Apex Consumer Court modified the orders passed by the District and State Commission and noted, "Considering the deficiency in service for which the OP Hospital is held culpable, the OP-1 Hospital is directed to pay the Complainant a lump sum compensation of Rs.2,00,000/- within a period one month from the date of this order. In the event of delay, the simple interest applicable thereon for such extended period shall be 12% per annum till the complete payment."

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-rs-2-lakh-compensation-241111.pdf

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