Changing Medical Treatment Plan does not imply medical negligence: NCDRC exonerates Apollo Hospital, Cardiologist

The surgery was conducted and the patient was discharged with advise to come back after a week. Meanwhile, the medical device maker sent a doctor for a final checkup on the ICD and it was revealed that the device does not give sufficient shock to prevent a heart attack, hence, the wounds of the patient had to be opened again to adjust the device in the patient’s heart. In light of this, the complainant strongly raised his complaint before the Hospital to which the Dr Ganjoo and Dr Rajput allegedly told the complainant that no charges are to be paid for re-adjusting the device.

Further, after the implantation, the hospital informed the complainant of a cost increase to USD 25,000 instead of USD 6500 as agreed initially, allegedly without clear justification. The complainant consented due to the patient's critical condition. However, the patient went back to Addis Ababa, Ethiopia where he collapsed and passed away after a few months of the implantation.

The complainant alleged that the ICD device planted by the hospital failed to work and save the patient. He further claimed that the ICD device was defective and couldn't save the patient from heart attack. Moreover, the hospital paid an amount of Rs 16,392/- as payment for readjusting the ICD device which clearly amounts to admission of negligence on part of the Hospital. Lastly, it was submitted that the complainant sent legal notice demanding payment of damages but the hospital and the medical device manufacturer failed to reply to the said notice. Aggrieved by the conduct, the complainant filed a complaint with the State Commission seeking compensation of Rs 90 lakhs for service deficiency causing distress and requested appropriate orders.

However, Indraprastha Apollo Hospital raised objections, questioning the complainant's legal standing and arguing against a manufacturing defect. On the other hand, Medical Devices India Pvt Ltd also challenged the complaint, citing limitations, lack of jurisdiction, and contesting a manufacturing defect.

Having dealt with the preliminary objections, the Commission firstly affirmed that the patient was advised to undergo an Angiography Test at Apollo Hospital based on recommendations from Dr R.K. Rajput, Senior Consultant Cardiology. The Angiography Report confirmed the patient's severe Coronary Artery Disease (CAD) along with significant Left Ventricle (LV) dysfunction, indicating a clear case of heart disease.

It then clarified on whether the hospital was trying to make extra money from the patient by installing the ICD device, since the complainant alleged that; "After an angiography test, Dr R.K. Rajput initially said, 'Your brother doesn't need a pacemaker!'. Later, after talking to another doctor, Dr Anoop K Ganjoo, he changed his mind and said the patient needed a pacemaker. But no clear reasons were given for this sudden change."

Acknowledging the issue, the Commission observed;

"Here, it is to be noted further that no expert medical opinion has been placed on record to suggest that the patient did not need a pacemaker or ICD device. Furthermore, the Complainant has not placed on record the documents pertaining to the past medical history of the patient. A bare perusal of the record makes it clear that the Complainant has merely made a bald averment without placing on record any cogent material to substantiate his claims when the Angiography Report suggests to the contrary. No cogent material has been placed on record to show that Dr. R.K. Rajput Senior Consultant Cardiology came out of the procedure room and apprised the Complainant “ Congratulations! Your brother is fine and does not need a pacemaker!" (as claimed by the complainant)."

The Commission further clarified that changing the mode of treatment doesn't alone establish negligence, and explained that;

"Even if it is assumed that the doctor changed the mode of treatment, the same cannot be the sole ground to arrive at an adverse finding against the treating consultants. Here it is important to remark that it is a common practice among medical professionals to change the course of treatment after having due deliberations and sharing opinions on a particular case with specialists. It is worthwhile to note that a doctor owes a duty of care in deciding what treatment to give and merely choosing an alternative course of action doesn’t create a presumption as to dereliction of duty, in the absence of any cogent proof to the contrary. Therefore, we opine that the contention of the Complainant that the ICD device was installed by the Apollo Hospital even though the patient did not require the same, holds no water."

Moreover, the Commission observed that the records don't show evidence of a faulty or inherently defective ICD device while expressing its stance on whether the death of the patient can be attributed to the device manufactured. It noted;

"It is pertinent to mention here that the patient returned to Ethiopia after getting his surgery done. However, no report of doctors whether Indian or Ethiopian, has been placed on record to indicate that the ICD device was defective or malfunctioned."

It was concluded that Medical Devices India Pvt Ltd, being the seller, isn't involved in device installation. Without clear evidence of ICD defects, no liability can be attributed to the medical device manufacturer.

Finally, addressing the core question whether the hospital's conduct led to the patient's death and constitutes medical negligence, the Commission was of the view that Invasive procedures like ICD implantation are vital for heart conditions, but complications can occur.

It observed;

"It is worthwhile to mention here that all medical procedures have some level of risk, particularly those involving the heart. It is not uncommon for individuals experiencing heart problems to be fitted with a pacemaker around the world. However, there are inherent risks to pacemaker implants. A doctor may make an error that can cause a complication, but in some cases, complications happen even though the doctor acted within the standard of care. Pacemakers are implanted into patients every day throughout the world. In fact, it is considered a routine procedure. Millions of people have undergone pacemaker implant procedures but there are still inherent risks associated with pacemaker implants. Some errors may be deemed errors in judgment, meaning that a reasonable physician could have conceivably made the same mistake. In other cases, medical complications may arise due to the procedure’s inherent risks, which are known to the patient and are included in any assumption of risk."

In this case, the patient received standard medical treatment following protocol. Coronary Angiogram and detailed ECHO were conducted to assess the need for CRTD or AICD. The treating consultant proceeded with AICD implantation after careful consideration and explaining the procedure. The patient was discharged but did not return for follow-up. It's important to note that the patient had multiple pre-existing health conditions, including dyslipidemia, hypertension, and a history of rectal carcinoma. The patient was already in a critical condition before approaching Apollo Hospital, with various complicating factors.

It was further clarified by the Commission that;

"When medical devices need to be implanted into someone’s body for health reasons, there is always the risk for complications. While pacemaker implantation is a relatively common procedure, it is still possible for problems to arise. However, every procedure related complication cannot be considered a result of malpractice unless it was caused by medical negligence. To constitute a procedure related injury in a medical facility, the injury must have been the direct result of a medical provider’s failure in providing an acceptable level of care."

Addressing the case at hand, the Commission said,

"In the present case, it is to be noted that the patient had smooth post-procedure course and was monitored constantly under the supervision of super-specialist doctors which is evident from the fact that routine interrogation of the device was carried out to ascertain whether the device was working effectively or not. During the routine interrogation, it was revealed that high voltage lead impedance or shock was out of range. Therefore, the treating doctors decided to re-explore the site wound for readjusting the AICD and to correct lead impedance. Hence, such conduct of the treating consultants sufficiently speaks of the meticulous care in the treatment extended to the patient."

"Again, it may be mentioned here that the Complainant has led no evidence of experts to prove the alleged medical negligence except his own affidavit. The experts could have proved if any of the doctors in the Opposite Party hospital providing treatment to the patient were deficient or negligent in service. No previous medical record of the patient has been placed on record for further assessment of his condition. A perusal of the existing medical record produced does not show any omission in the manner of treatment. Thus, the possibility of breach of duty to provide reasonable care is ruled out and it cannot be said that the surgical procedure was the proximate cause of death of the patient."

Summarizing the concern, the Commission affirmed that establishing negligence against the Hospital hinges on res ipsa loquitor, which isn't applicable here considering the provided treatment records. Res ipsa loquitor requires not only negligence evident in the matter but also its clear attribution to the Hospital. Various medical experts were available for treatment and guidance in this case. While doctors are expected to exercise reasonable care, they can't guarantee a definite recovery from ailments.

Lastly, examining the Complainant's claim of extra charges by the Hospital for the AICD device, the State Commission said that AICD-related complications result in higher healthcare expenses due to the cost of these life-saving devices and the invasive implantation procedure. However, there is insufficient evidence on record to confirm that the initial treatment agreement was for USD 6,000 and that the Hospital later raised the device cost.

In light of the above discussion, the Commission concluded that no negligence was made out on part of Indraprastha Apollo Hospital and Medical Devices India Pvt Ltd, and eventually dismissed the complaint against them. It held;

"Therefore we conclude that the treating consultants and staff of the Opposite Party No.-1 Hospital have exercised reasonable competence and care while treating the patient in all circumstances. Still, despite all standards of care and precautions taken during the treatment, complications may arise. The patient was discharged in healthy condition and lived more than 6 months after the procedure, which is in itself a conclusive proof that the patient was treated as per the standard medical procedure. However, in an unfortunate case, death may occur. Here, it is necessary to remark that sufficient material or medical evidence should be made available before an adjudicating authority to arrive at the conclusion that death is due to medical negligence. Every death of a patient cannot on the face of it be considered to be medical negligence."

To view the original judgement, click on the link below: