Amputation Post Surgery: Vascular Surgeon, Hospital slapped Rs 75 lakh compensation for medical negligence

The bench comprising Presiding Member Subhash Chandra and Member AVM J Rajendra AVSM VSM (Retd.) found the doctor and hospital jointly guilty of medical negligence and deficiency in service that included misrepresentation of post-surgical complications, inadequate informed consent, and failure to explore alternative treatment options.

Furthermore, by holding the hospital equally liable, the Commission clarified that hospitals cannot evade liability merely by arguing that a doctor was independently responsible for a procedure performed on their premises.

Case Background

The case involved a 17-year-old patient who had been experiencing swelling in the right gluteal region since 2000. Initially, doctors suspected a neurofibroma and assured the family that there was no cause for concern. However, by 2011, the swelling had increased, occasionally causing pain. In 2014, an FNAC test suggested a probable diagnosis of angiolipoma. The family continued consultations and was eventually referred to Dr. Anirban Chatterjee, a vascular surgeon, in 2015.

After reviewing the patient’s medical history, the surgeon recommended further diagnostic tests, including a CT angiography, which revealed an Arteriovenous Malformation (AVM) in the right buttock. Based on this diagnosis, the surgeon suggested vascular embolization to manage the condition. The procedure was performed at Nightingale Diagnostic & Medicare Centre Pvt. Ltd. on September 16, 2015.

Allegations of Medical Negligence

A complaint was filed under Section 21 of the Consumer Protection Act, 1986, by a woman and her daughter, a minor, seeking compensation of Rs 20.41 crore for alleged negligence.

According to the complainants, during the embolization procedure, a small amount of N-Butyl Cyanoacrylate (NBCA) glue accidentally entered the main artery of the right leg. The surgeon assured them that it was a minor issue that could be corrected through a follow-up procedure the next day.

However, after the second procedure on September 17, 2015, the patient developed gangrene due to the cessation of blood circulation in her right leg. She was then transferred to Sir Ganga Ram Hospital in Delhi on September 19, 2015, where doctors found that her condition had deteriorated significantly, ultimately necessitating amputation of her right leg above the knee on September 22, 2015.

The complainants alleged that the doctor failed to explore alternative treatment options, such as bypass surgery, misrepresented the severity of the complications and falsely reassured them of post-surgical improvement. They further alleged that no adequate preventive measures were taken to address post-procedure risks.

Response by the Surgeon and Hospital

Dr Chatterjee and the hospital strongly contested the allegations, arguing that AVM embolization is a high-risk procedure with known complications, including non-target embolization. They emphasized that the complainants had signed a high-risk consent form acknowledging these risks before the surgery.

The surgeon asserted that the glue ratio used during the procedure was within the standard medical guidelines and was supported by scientific literature. He further contended that alternative treatments, such as bypass surgery, were not viable and that this was confirmed by cardiothoracic surgeon Dr Susan Mukherjee. The doctor also stated that he personally facilitated the patient’s transfer to Sir Ganga Ram Hospital and remained actively involved in her care.

Additionally, the hospital argued that it only provided the infrastructure, such as the cath lab, operation theater, and nursing care, while the doctor was an independent consultant and not under their direct employment. The hospital denied any liability for the alleged negligence.

NCDRC's Findings and Observations

The Commission examined the case, scrutinizing the diagnosis, treatment, risk disclosure, post-operative care, and the responsibilities of both the treating doctor and the hospital. The Commission evaluated whether Dr Anirban Chatterjee and Nightingale Hospital exercised reasonable care in treating the patient and whether their actions or omissions constituted medical negligence.

The Commission cited previous Supreme Court rulings on medical negligence, including Samira Kohli v. Dr Prabha Manchanda (2008) and Jacob Mathew v. State of Punjab (2005), to underline that failure to inform risks constitutes a breach of duty.

1. Medical Procedure, Risk Disclosure, and Informed Consent

The primary allegation of medical negligence revolved around the lack of sufficient risk disclosure regarding the AVM embolization procedure. The NCDRC emphasized that doctors must provide patients and their families with comprehensive information on treatment risks, alternative options, and expected outcomes before obtaining consent. It observed;

"The diagnosis and treatment are in the domain of doctor and the patient is a passive participant. When advice is being given to the patient, the patient assumes an active role. Then doctors‟ function is to empower and enable the patient to make a decision by giving him/ her relevant, sufficient and material information. The patient must make choices and decisions. The patient must be informed about the options for treatment, its consequences, risks and benefits. Why a doctor thinks particular treatment necessary and appropriate for the patient. The prognosis and what may happen if treatment is delayed or not given. Failing to furnish correct sufficient information when obtaining consent may be a breach of duty of care. It amounts to negligence, failure to inform the patient. The patient must be given a reasonable amount of time to consider the information to make a decision. The allowing of cooling off period is for the purpose of giving time to think over the decision or take advice so that a patient does not feel pressurized or rushed to sign. On the day of surgery, the patient may be under strain, mental stress or under influence of the pre-procedure drugs which may hamper his decision-making ability. The doctor performing any procedure must obtain the patient's consent. No one else can consent on behalf of the competent adult. The consent should be properly documented and preferably witnessed as such consent is legally more acceptable. The video recording of the informed consent process may also be done with prior consent of the patient."

The Commission highlighted the lack of specific mention of glue leakage as a potential complication in the consent form. It noted;

“The information details provided do not have any mention of the risk of ‘leakage on the glue’ and the likely implications.”

The Commission further underscored that informed consent is not merely a procedural formality but a fundamental right of the patient. It observed;

"Discussing all complications with the patient and attending relatives is a necessity, so that she may make up her mind for surgery. Before commencing a treatment or procedure, an „Informed Consent‟ is required to be obtained satisfy the following conditions:

“The consenting party i.e. the patient or his/her family members must be aware of the nature and extent of complications and risks of the surgery. The consenting party must have understood the nature and extent of the complications and risks and the consenting party or his/her family members must have consented to the harm and assumed risk. Comprehensive explanation of the possible complications and risks and the extent of entire procedure and transaction, inclusive of all its consequences, must be explained to the patient or his/her family members.”"

Additionally, the Commission rejected the hospital’s argument that the signed high-risk consent form absolved them of liability, observing that;

"The consent obtained in the present case and the assertions made by the OPs in defence are of limited consequence. If the surgery entailed High Risk as asserted by OPs, it was even more imperative for the OPs to elicit the necessary responses with specific questions with respect to the medical history and associated conditions of patient to determine her risk potential and take necessary preventive measures as well as effective measures to deal with the situation of handling such subsequent conditions. This was not done and, after the slippage of the chemical Glue into the artery and the blood flow was blocked, the patient had to be urgently shifted to Ganga Ram Hospital in Delhi in very critical condition, where her right leg was amputated."

"In the case in question, the High Risk Consent Form with respect to the AVM embolization surgery dated 16.09.2015 is placed on record. This is a printed format with the information given, explanation made, possible risks during the surgical procedures, anesthetic procedures, medications and pre-existing and current medical conditions. It also indicates the consent of the possibility of unforeseen conditions arising. Therefore, it is unclear as to whether the said High Risk due to which the patient in fact lost her leg, was informed to them at that stage at all. Therefore, this Consent cannot be termed as an informed consent for accepting such High Risk, as contended by OPs."

The Commission further explained;

"In the light of these facts and statutory provisions, the “Bolam Test” can no longer be applied to a doctor's advice to his patient, unless it complies with the statutory provisions. The information given to the patient has to be examined from the patient's perspective. The information disclosed is not limited to risk-related inputs. It should include doctor's diagnosis of the patient's condition, the prognosis of that condition with and without medical treatment, the nature of proposed medical treatment and the risks associated with it, the alternative to the proposed medical treatment, advantages and risks of the said treatment and the proposed treatment. The doctor must ensure that information given is “in terms and at a pace that allows the patient to assimilate it, thereby enabling the patient to make informed decision”."

2. Post-Operative Complications and Duty of Care

Following the procedure, the patient developed severe complications, including complete loss of circulation in the right leg, ultimately necessitating amputation. The Commission observed that while the complication was identified, the measures taken were not sufficient to prevent permanent disability.

“The contention of the OP-1 that he had not received any fees for the treatment of the patient in question and, in the absence of any consideration, she does not constitute a consumer is also untenable as, clearly, the parents of the child paid the fees to the Hospital and that itself constitutes the consideration with respect to OP-1 as well.”

3. Finding of Medical Negligence and Deficiency in Service

The NCDRC held both the surgeon and Nightingale Hospital liable for medical negligence and deficiency in service, stating;

“In view of the foregoing deliberations and the decisions of the Hon’ble Supreme Court, the negligence and deficiency in service on the part of the OPs is manifest.”

Subsequently, the Commission concluded that the complications arising from glue slippage, which ultimately led to the amputation, should have been explicitly discussed with the patient and her family beforehand. The failure to do so constituted medical negligence. It held;

"In the present case, undisputedly the patient who of 17 years at the time of surgery, lost her right leg till above knee and thus left permanently disabled. The negligence in performing the AVM Surgery by the OP is manifest and she is otherwise in healthy condition. Without doubt, the unexpected consequence of amputation of her leg has resulted in severely impacting on her self-esteem, employability as well as living her life with dignity. She was issued with a Certificate by RG Kar Medical C. Hospital, Kolkata dated 25.11.2016 declaring that she suffered 90% permanent disability. The patient who suffered the consequences is a girl child and thus the implications are even more profound. The Complainants stated to have incurred Rs.2,00,000 towards the surgery itself and spent Rs.7,25,000/- for prosthetic leg, which needs regular replacement. Therefore, there is certainly a need to compensate her for the pain, suffering and loss of future prospects, gainful employment, settlement and trauma and enable her to live her life with reasonable security and dignity. With due regard to the foregoing, we consider it appropriate to award a lumpsum compensation of Rs. 75 Lakhs to be paid jointly and severally by the OPs to the Complainants, within a period of one month from the date of this order. In the event of delay beyond one month, the OPs are also liable to pay simple interest @ 12% per annum on Rs.75 Lakhs till the date of final payment."

"With due regard to the entire facts and circumstances of the case, the OPs are also directed to pay Rs. 50,000/- to the Complainants as costs of litigation."

Click on the link below to view the original order: