Medical Negligence in Nasotracheal Intubation: SC relief to Nagpur Hospital, ICU in-charge, Radiologist, ENT Surgeon

A bench comprising justices Hrishikesh Roy and Manoj Misra set aside an order by the National Consumer Disputes Redressal Commission (NCDRC) passed in February 2018, directing Suretech Hospital and Research Centre Private Limited, and its doctors to pay a compensation of over Rs 6 lakh to a woman, who claimed to have suffered a permanent damage to her respiratory tract due to medical negligence.

The apex court clarified that in order to safeguard medical practitioners and to ensure that they are able to freely discharge their medical duty, a higher proof of burden must be fulfilled by the complainant. Moreover, it observed that there was nothing to show that a procedure (Nasotracheal Intubation) conducted on a patient, who met with a serious car accident on May 5, 2004, was outdated or poor medical practice.

The Case:

The case revolves around a patient who on May 5, 2004 was rushed to Gondia Hospital just 15 minutes after a severe car accident near Gondia. She sustained multiple injuries, including a left mandibular (lower jaw) fracture and a right clavicle (collar bone) fracture. In an emergency response, Dr Agarwal performed a tracheostomy, creating an opening in her neck to assist with breathing.

The next day the patient was transferred from Gondia Hospital to the ICU at Suretech Hospital in Nagpur, supervised by Dr Jaiswal. She was placed on a ventilator through her Tracheostomy Tube (TT), which was removed after a couple of days.

Thereafter, Dr Saoji at Suretech Hospital conducted a 'Mandibular Bracing Surgery' through the TT to set her left mandibular fracture. This was followed by a Bronchoscopy performed by the three doctors to examine the patient's airways, Larynx, and Trachea. Despite the Bronchoscopy showing a normal air passage, indicating she could breathe normally through the existing TT, the doctors removed the TT and forcefully conducted 'Nasotracheal Intubation' (NI) by inserting an Endotracheal tube through her nose for breathing.

Before the NI procedure, the patient was being fed through a Ryle’s Tube inserted through her nose to her stomach. However, to accommodate the Nasotracheal Tube (NT), the Ryle’s Tube was removed. As a result, the liquid feed started entering her respiratory tract, leading to severe infection and 'Severe Septicemia.' The inflated cuff of the NT was the cause of food entering the respiratory tract. Pus leaked through the stitched tracheostomy wound, paralyzing her vocal cords.

It was alleged that on May 25, 2004, a 'Barium Swallow Test' was conducted against the family's resistance due to potential danger, forcefully administered without a doctor's presence. The patient experienced severe breathlessness and was saved by Dr Kalidas Parshuramkar, who removed the aspirated solution from her tracheostomy wound and lower trachea.

Dissatisfied with her treatment at Suretech Hospital, the patient sought discharge. On May 27, 2004, she went to Mumbai, where Dr Sultan Pradhan in Prince Aly Khan Hospital advised treating life-threatening conditions, including 'Severe Septicemia' and 'Severe Thrombocytopenia.' Dr Pradhan reinserted the TT without a cuff through the existing tracheostomy wound.

The patient alleged that all subsequent complications were due to the NI procedure. After various medical evaluations, she underwent tracheal reconstruction surgery (tracheoplasty) on January 30, 2005. Her windpipe was shortened, leading to permanent voice loss.

Aggrieved, the patient filed a consumer case alleging medical negligence, seeking compensation of Rs 3,58,85,249 (over Rs 3 crore) with interest. She claimed that negligence caused 'Severe Septicemia,' 'Severe Thrombocytopenia,' vision loss, and permanent damage to her respiratory tract, including voice loss. The forced 'NI' procedure resulted in Grade-IV Subglottic Stenosis, leading to severe complications.

NCDRC Judgment:

In its judgment, the NCDRC identified negligence in the replacement of the 'TT' with 'NI,' emphasizing that this change lacked medical justification, especially when the patient was responding well to her existing treatment. The expert medical committee report from RML Hospital failed to address the unwarranted 'NI' procedure, and Dr Madhusudan Shendre's inconsistent statements raised doubts about the 'NI' replacement's justification. The patient's claim of negligence causing thrombocytopenia was not substantiated, as her platelet count remained within the normal range. Charges of negligence for the 'Barium Swallow Test' and vision loss were rejected, considering clinical necessity and the timing of vision issues. The NCDRC also stressed that a single act of negligence couldn't solely explain subsequent medical complications, often encountered after severe road accidents. Consequently, the patient was awarded compensation of Rs 6,11,638 at 9% p.a. for medical expenses incurred at Suretech Hospital. An additional Rs 50,000 was granted to cover litigation expenses due to the one proven act of negligence.

Pleadings Assailing The Impugned NCDRC Judgement:

Challenging the NCDRC Judgment dated 16.02.2018, the patient filed Civil Appeal 4847 of 2018, seeking an increase in her compensation from Rs 6,11,638 and a higher interest rate of 18% instead of the awarded 9% per annum. She agreed with the NCDRC's finding of medical negligence regarding the unnecessary 'NI' procedure replacing the 'TT' but disagreed with its conclusion that there was no direct link between this act of negligence and subsequent severe medical complications, permanent respiratory damage, and voice loss.

The patient argued that the forced 'NI' was the sole reason for her voice loss and tracheal stenosis, despite the Bronchoscopy report indicating a normal airway and her stable condition with the 'TT.' She claimed that the 'NI' procedure caused tracheal injury, leading to Frank Pus and severe septicemia. She alleged that Suretech Hospital's discharge summary concealed the negligent act. On 30.01.2005, Dr. A.G. Pusalkar performed tracheoplasty, excising a 3.5cm Grade-IV subglottic stenotic segment. As a result, the patient had to live with a shortened windpipe, and she sought Rs. 75,00,000 for the deformity of her respiratory tract and another Rs. 75,00,000 for losing her voice, along with Rs. 5,00,000 for permanent neck disfigurement. She further requested Rs. 50,00,000 for the mental and physical suffering endured during her prolonged treatment, Rs. 15,00,000 for the impact on her husband, and Rs. 25,00,000 for the mental stress and agony suffered by him. An additional Rs. 20,00,000 was claimed collectively for the suffering experienced by their children due to her disability.

In response to the allegations, Dr M.A Biviji (Radiologist) filed a civil appeal challenging the charge of negligence in the 'Barium Swallow Test.' Additionally, Suretech Hospital, Dr Jaiswal, and Dr Shendre (ENT Surgeon) filed an appeal, arguing that the medical experts from Ram Manohar Lohia (RML) Hospital found no negligence in the 'NI' procedure that replaced the 'TT.' They emphasized that subsequent hospitals and doctors did not establish a direct link between the 'NI' procedure and the alleged medical complications and tracheal stenosis.

The medical records didn't indicate any issues with the 'NI' procedure, and the complainant lacked evidence to support her negligence claim. The NCDRC's conclusion conflicted with its findings in other parts of the case, and there was no clear causal connection between the 'NI' procedure on 13.05.2004 and the patient's injuries and complications.

Dr Jaiswal, as the ICU incharge, argued that they provided immediate care, and the patient didn't prove a breach of duty or any resulting harm. The medical board found no negligence and confirmed that they provided appropriate treatment.

Dr Shendre explained that the choice of the 'NI' procedure was based on the patient's condition and the necessity to support the trachea for healing. The complications couldn't be directly linked to the 'NI' procedure, as the patient received treatment at multiple hospitals and underwent different procedures.

SC Discussion and Reasoning:

The Supreme Court reviewed various charges made by the complainant and the responses from the doctors involved. The bench noted that the National Consumer Disputes Redressal Commission (NCDRC) had already determined that several charges, including claims of negligence related to blurred vision, thrombocytopenia (a significant drop in platelet levels), and issues arising from the 'Barium Swallow Test,' were not substantiated.

Regarding the charge of negligence in diagnosing blurred vision, it was confirmed that two different ophthalmologists at Suretech Hospital, along with further diagnostic tests like CT scans and MRI scans, found a normal retina. Concerning thrombocytopenia, the medical intervention was initiated when platelet levels dropped below 26,000, which exceeded the standard threshold of 20,000. Intravenous immunoglobulin treatment was planned in advance, and a bone marrow examination was conducted to explore potential underlying causes. The treatment effectively increased platelet levels, and the expert committee concluded that the hospital had properly managed the patient's septicemia and thrombocytopenia. Therefore, these charges were rightly considered unproven by the NCDRC.

As for the 'Barium Swallow Test,' it was clarified that this test was conducted to investigate the leakage of orally administered liquid feed through the wound, which was a routine procedure. The solution used, Barium Sulphate, was non-toxic and posed minimal danger to patients. Thus, the NCDRC correctly found these charges to be unsupported.

The central issue in the case, according to the SC, revolved around the 'NI' procedure performed on the patient on 13.05.2004 at Hospital, during which the existing 'TT' was replaced despite a bronchoscopy report indicating normal airways. The key question was whether this act amounted to negligence and, if so, whether the subsequent medical complications, such as permanent respiratory tract deformity and voice loss, could be solely attributed to this specific act of negligence.

The SC referred to established legal precedents, specifically the cases of Jacob Mathew vs. State of Punjab and Kusum Sharma vs. Batra Hospital. These cases emphasized that evaluating negligence in the medical profession should consider the specific standards and practices of the medical community at the time of the incident. Medical professionals should be judged based on the standards of reasonably competent practitioners in their field. Furthermore, in matters of diagnosis and treatment, there is room for genuine differences of opinion among medical professionals.

The court also acknowledged that medical practitioners often have to make decisions involving varying levels of risk and should not be held liable if their chosen course of action was acceptable within the medical community, even if the outcome was not as desired. The court's ultimate duty is to ensure that medical professionals are not unfairly harassed or humiliated, allowing them to perform their responsibilities without fear or apprehension.

Based on these legal principles and standards, the court needed to assess whether the 'NI' procedure constituted negligence and, if so, whether it directly and solely resulted in the subsequent medical complications suffered by the patient. This required a careful examination of the evidence and expert opinions.

In light of this discussion, the SC identified the three key elements in establishing an act of medical negligence: (1) a duty of care to the complainant, (2) a breach of that duty of care, and (3) resulting damage, injury, or harm caused to the complainant attributable to the breach of duty. However, a medical practitioner would only be held liable for negligence when their conduct falls below the standards of a reasonably competent practitioner.

Consequently, the bench observed;

"Due to the unique circumstances and complications that arise in different individual cases, coupled with the constant advancement in the medical field and its practices, it is natural that there shall always be different opinions, including contesting views regarding the chosen line of treatment, or the course of action to be undertaken. In such circumstances, just because a doctor opts for a particular line of treatment but does not achieve the desired result, they cannot be held liable for negligence, provided that the said course of action undertaken was recognized as sound and relevant medical practice. This may include a procedure entailing a higher risk element as well, which was opted for after due consideration and deliberation by the doctor. Therefore, a line of treatment undertaken should not be of a discarded or obsolete category in any circumstance."

It added;

"To hold a medical practitioner liable for negligence, a higher threshold limit must be met. This is to ensure that these doctors are focused on deciding the best course of treatment as per their assessment rather than being concerned about possible persecution or harassment that they may be subjected to in high-risk medical situations. Therefore, to safeguard these medical practitioners and to ensure that they are able to freely discharge their medical duty, a higher proof of burden must be fulfilled by the complainant. The complainant should be able to prove a breach of duty and the subsequent injury being attributable to the aforesaid breach as well, in order to hold a doctor liable for medical negligence. On the other hand, doctors need to establish that they had followed reasonable standards of medical practice."

In evaluating whether the 'NI' procedure conducted on the patient amounted to negligence, the court emphasized the need to consider whether there was a breach of the duty of care in the 'NI' procedure and, if so, to attribute this breach to the responsible party. Furthermore, it was crucial to establish a direct link between the subsequent medical complications, including permanent respiratory tract deformity and voice loss, and the breach of the duty of care.

The central issue was whether the 'NI' procedure was an alternative, necessary, or ill-advised treatment. The NCDRC deemed it unjustified since the patient was already breathing normally with the 'TT,' and the 'NI' procedure was temporary, whereas the 'TT' provided extended support. However, removing the 'TT' was necessary for her recovery due to potential risks associated with long-term 'TT' intubation. Despite a successful initial recovery, decannulation failed, and the patient developed a stridor. A reexamination revealed tracheal trauma, potentially from the accident or an earlier 'TT' procedure. In this context, the 'NI' procedure was a medically justifiable alternative to address her breathing difficulties and prevent further complications. It was an appropriate response to the specific circumstances, the bench stated.

Conclusion:

In conclusion, the SC said that the 'NI' procedure was a reasonable course of action considering the difficulties with 'TT' decannulation and the subsequent tracheal trauma. Therefore, it couldn't be considered a breach of the duty of care or medical negligence. It noted;

"After the difficulties faced during the ‘TT’ decannulation process and the discovery of a stridor, opting for the ‘NI’ procedure as an alternative course of treatment to aid respiration could be medically justified as well. The expert medical report by RML hospital stated that tracheal trauma, fractures and injuries in the laryngeal framework, leading to subsequent medical complications such as subglottic stenosis were common after severe injuries sustained in a serious road accident. After difficulties arising out of ‘TT’ decannulation, reinserting the ‘TT’ might have resulted in the similar or worse difficulties as well. Therefore, resorting to the ‘NI’ procedure as an alternative method to provide breathing assistance did not appear to be out of place either. As an accepted medical course of action, it was expected that the procedure would aid with recovery and lead to the desired results which did not happen. However, that cannot be said to be a breach of duty amounting to negligence either. As was rightly observed in the Jacob Mathew case and Kusum Sharma case, adopting an alternative medical course of action would not amount to medical negligence."

It further explained;

"As reasoned earlier, the burden of establishing negligence is on the complainant. In this case, however, the patient had failed to prove medical negligence by the doctors. There is no evidence to establish that the ‘NI’ procedure is a bad medical practice or based on unsound medical advice. None of the hospitals where the patient was treated prior to Suretech Hospital opined that the ‘NI’ procedure was not medically acceptable. Additionally, none of the doctors who treated her subsequently opined that the ‘NI’ treatment was not a medically acceptable practice or that the said procedure had been performed negligently. On the other hand, the medical team at Suretech Hospital was able to successfully prove that due medical consideration was given before choosing the aforesaid ‘NI’ procedure. Therefore, no negligence was committed in opting for and/or conducting the aforesaid procedure."

In light of the same, the bench noted that;

"An alternative course of treatment in the form of an ‘NI’ procedure was opted for as a temporary measure. There is nothing to show that the procedure conducted was outdated or poor medical practice."

The court also found it important to note that the sole medical report available, the RML Hospital Committee Report, did not attribute any negligence to Suretech Hospital, Dr. Biviji, Dr. Jaiswal, or Dr. Shendre concerning the charges against them. It observed;

"It must be pointed out that the only medical report available in this case i.e., the RML Hospital Committee Report did not attribute any negligence to Suretech Hospital, Dr. Biviji, Dr. Jaiswal or Dr. Shendre with respect to any of the charges levelled against them. If the ‘NI’ procedure had been conducted in a negligent manner or was a poor medical decision, it is likely that the RML Hospital Committee Report would have mentioned the same. However, no such observation was made either. Further, none of the doctors that treated the patient commented adversely with respect to the chosen course of treatment. Therefore, there is no substance to establish the causal link between the ‘NI’ procedure that was undertaken at Suretech Hospital and the subsequent medical complications that arose."

The SC emphasized that medical practice is characterized by its imperfections, evolving knowledge, uncertain information, and the involvement of fallible individuals. Medicine relies on both science and non-scientific factors like habits and intuition. There's often a gap between medical knowledge and desired outcomes, especially when dealing with people's lives.

Consequently, the bench absolved the hospital and the doctors and dismissed the order issued by the Commission. It said that;

"This is a classic case of human fallibility where the doctors tried to do the best for the patient as per their expertise and emerging situations. However, the desired results could not be achieved. Looking at the line of treatment in the present matter, it cannot be said with certainty that it was a case of medical negligence."

The court concluded that there was no breach of the duty of care at Suretech Hospital or on the part of Dr Biviji, Dr Jaiswal, and Dr Shendre. The charge of negligence was not proven, and the judgment awarding compensation on account of medical negligence was found to be erroneous and set aside. It held;

"Resultantly, we hold that there was no breach of duty of care at Suretech Hospital or on part of Dr. Biviji, Dr. Jaiswal and/or Dr. Shendre. The charge of negligence is, therefore, not proved. Hence, the impugned judgment awarding Rs. 6,11,638/- as compensation @ 9% simple interest p.a. on account of medical negligence committed by the single act of performing the aforesaid ‘NI’ procedure, is found to be erroneous and is set aside."

Subsequently, the appeals filed by Dr. M.A. Biviji, Dr. Nirmal Jaiswal, Dr. Madhusudan Shendre, and Suretech Hospital were allowed.

"Resultantly, the appeal filed by Dr. M.A Biviji (Civil Appeal No. 3975 of 2018) as well as the appeal filed by Dr. Nirmal Jaiswal, Dr. Madhusudan Shendre and Suretech Hospital (Civil Appeal arising out of Diary No. 21513 of 2018) are allowed to the extent that the charges attributing medical negligence to Suretech Hospital, Dr. Biviji, Dr. Jaiswal, and Dr. Shendre are found not proved. The appeal filed by Mrs. Sunita (Civil Appeal No. 4847 of 2018) is accordingly dismissed. Parties to bear their own cost."