LEGAL ISSUE: Whether the performance of a Nasotracheal Intubation (NI) procedure, after a bronchoscopy indicated normal airways, constitutes medical negligence, and whether subsequent medical complications can be directly linked to this procedure.
CASE TYPE: Consumer Protection/Medical Negligence
Case Name: M.A Biviji vs. Sunita & Ors.
[Judgment Date]: 19 October 2023
Introduction
Date of the Judgment: 19 October 2023
Citation: 2023 INSC 938
Judges: Hrishikesh Roy, J., Manoj Misra, J.
Can a medical procedure, performed after a seemingly normal diagnostic report, still be considered negligent? The Supreme Court of India recently addressed this complex question in a case involving a patient who suffered severe complications after a Nasotracheal Intubation (NI) procedure. The court examined whether the procedure was indeed negligent and if it directly led to the patient’s subsequent health issues.
The Supreme Court bench, comprising Justices Hrishikesh Roy and Manoj Misra, delivered the judgment. The court overturned the National Consumer Disputes Redressal Commission’s (NCDRC) finding of medical negligence, concluding that the procedure was a medically justifiable alternative and not a breach of duty of care.
Case Background
On 05 May 2004, Mrs. Sunita was involved in a serious car accident near Gondia, sustaining multiple injuries including a mandibular fracture and a clavicle fracture. She was initially taken to Gondia hospital where a tracheostomy was performed by Dr. Vimlesh Agarwal to assist her breathing. The following day, on 06 May 2004, she was transferred to Suretech Hospital in Nagpur under the supervision of Dr. Nirmal Jaiswal. She was placed on a ventilator through her tracheostomy tube (TT), which was removed on 08 May 2004. On 11 May 2004, Dr. Vinay Saoji performed surgery to set her mandibular fracture, with the surgery being performed through the existing TT.
On 13 May 2004, Mrs. Sunita underwent a bronchoscopy. Despite the bronchoscopy indicating a normal airway, the doctors, Dr. Nirmal Jaiswal and Dr. Madhusudan Shendre, removed the TT and performed a Nasotracheal Intubation (NI) procedure. This involved inserting an endotracheal tube through her nose. Prior to this, she was fed through a Ryle’s tube (inserted through the nose to the stomach). However, to accommodate the NI tube, the Ryle’s tube was removed, and she was given liquid oral feed. This resulted in food entering her respiratory tract, leading to severe infection and septicemia. Pus started leaking from the tracheostomy wound, and her vocal cords were paralyzed.
On 25 May 2004, a Barium Swallow Test was conducted, despite resistance from her family, to check for abnormalities in her digestive tract. Mrs. Sunita experienced extreme breathlessness after consuming the barium solution. On 27 May 2004, she was discharged from Suretech Hospital and sought treatment in Mumbai. She was later admitted to Shanti Prabha Nursing Home in Nagpur and then returned to Mumbai for further treatment.
She underwent a tracheoplasty on 30 January 2005, resulting in a shortened windpipe and permanent voice loss. Subsequently, Mrs. Sunita filed a consumer case against the doctors at Suretech Hospital, alleging medical negligence, which was partly allowed by the NCDRC, and then appealed to the Supreme Court.
Timeline:
Date | Event |
---|---|
05 May 2004 | Mrs. Sunita meets with a serious car accident near Gondia and is taken to Gondia hospital. A tracheostomy is performed. |
06 May 2004 | Mrs. Sunita is shifted to Suretech Hospital, Nagpur, and placed under the supervision of Dr. Nirmal Jaiswal. |
08 May 2004 | Mrs. Sunita is weaned off the ventilator. |
11 May 2004 | Dr. Vinay Saoji performs Mandibular Bracing Surgery. |
13 May 2004 | Mrs. Sunita undergoes bronchoscopy, followed by the removal of the tracheostomy tube (TT) and a Nasotracheal Intubation (NI) procedure. |
25 May 2004 | A Barium Swallow Test is conducted. |
27 May 2004 | Mrs. Sunita is discharged from Suretech Hospital and seeks treatment in Mumbai. |
03 June 2004 | Mrs. Sunita undergoes a Fiber Optic Bronchoscopy at Shanti Prabha Nursing Home, Nagpur, revealing two openings in her trachea. |
03 July 2004 | Dr. Pradhan conducts a laryngoscopy and pharyngoscopy in Mumbai, revealing complete laryngostenosis. |
30 January 2005 | Dr. Pusalkar performs tracheoplasty. |
14 March 2005 | The tracheostomy tube (TT) is removed, and doctors realize Mrs. Sunita’s speech cannot be restored. |
16 May 2005 | Mrs. Sunita files a consumer case before the NCDRC. |
16 February 2018 | The NCDRC partly allows Mrs. Sunita’s complaint. |
19 October 2023 | The Supreme Court of India overturns the NCDRC’s decision. |
Course of Proceedings
Mrs. Sunita filed a consumer case before the National Consumer Disputes Redressal Commission (NCDRC), alleging medical negligence against Suretech Hospital and its doctors, seeking compensation of Rs. 3,58,85,249. The NCDRC partly allowed her complaint, awarding her Rs. 6,11,638 as compensation with 9% interest, along with Rs. 50,000 for litigation costs. The NCDRC found negligence in the performance of the NI procedure but did not link it to the subsequent medical complications.
Dissatisfied with the compensation amount, Mrs. Sunita filed a civil appeal (Civil Appeal No. 4847 of 2018) before the Supreme Court, seeking an enhancement of the compensation and an increase in the interest rate to 18%. The doctors, Dr. M.A. Biviji, Dr. Nirmal Jaiswal, and Dr. Madhusudan Shendre, along with Suretech Hospital, also filed appeals (Civil Appeal No. 3975 of 2018 and Civil Appeal (Diary) No. 21513 of 2018) challenging the NCDRC’s finding of medical negligence. They argued that the NI procedure was a medically justifiable alternative and not a breach of duty.
Legal Framework
The primary legal framework for this case is the Consumer Protection Act, 1986, specifically Section 23, under which the civil appeals were filed. This section provides for appeals against the orders of the National Consumer Disputes Redressal Commission (NCDRC). The case also involves the interpretation of medical negligence, drawing from established legal precedents.
The Supreme Court referred to the following cases to define medical negligence:
- Jacob Mathew vs. State of Punjab: This case defined negligence as a breach of duty caused by omission or commission, and outlined the essential components of negligence as duty, breach, and resulting damage. It also emphasized that medical professionals should not be held liable for errors in judgment if they follow acceptable medical practices.
- Kusum Sharma vs. Batra Hospital: This case laid down principles for determining medical negligence, emphasizing the need for a reasonable degree of skill and care, and that a difference of opinion does not constitute negligence.
These cases highlight that for a medical professional to be held liable for negligence, their conduct must fall below the standards of a reasonably competent practitioner in their field. The legal framework also acknowledges that medical practice is not an exact science, and doctors are expected to make decisions based on their best judgment.
Arguments
Arguments of Mrs. Sunita (Complainant):
- Mrs. Sunita argued that the forced Nasotracheal Intubation (NI) procedure, replacing the existing tracheostomy tube (TT), was the direct cause of her subsequent medical complications, including permanent respiratory damage and voice loss.
- She contended that the bronchoscopy report on 13 May 2004 indicated a normal airway, making the NI procedure unnecessary and negligent.
- She claimed that the NI procedure was performed despite multiple failed attempts to decannulate the TT.
- She submitted that she developed Frank Pus and Severe Septicemia due to the tracheal injury caused by the NI procedure.
- She argued that the hospital’s discharge summary did not mention the NI procedure, suggesting an attempt to conceal the negligent act.
- She sought enhanced compensation for the permanent deformity of her respiratory tract, loss of voice, disfiguration of her neck, mental and physical suffering, and the impact on her family.
- She relied on medical science, stating that 95% of subglottic stenosis cases are acquired, and 90% of those result from traumatic NI.
Arguments of Dr. M.A. Biviji:
- Dr. Biviji argued that he, as a radiologist, had no role in conducting the bronchoscopy or NI procedure on 13 May 2004.
- He stated that the Barium Swallow Test was essential to understand why liquid feed was leaking from Mrs. Sunita’s tracheostomy wound.
- He claimed that the Barium Sulphate solution used for the test is non-toxic and harmless.
- He asserted that he was present during the test, as required for taking multiple X-rays.
Arguments of Dr. Nirmal Jaiswal, Dr. Madhusudan Shendre, and Suretech Hospital:
- They argued that the expert medical board did not find any negligence in performing the NI procedure.
- They claimed that no other hospital or doctor made a causal connection between the NI procedure and the subsequent medical complications.
- They contended that Mrs. Sunita failed to produce evidence substantiating the negligence.
- They stated that Dr. Rajesh Swarnakar, a pulmonologist and bronchoscopist, conducted the bronchoscopy and NI procedure.
- They argued that the complainant did not implead necessary parties, such as Dr. Swarnakar and other specialists, making the complaint not maintainable.
- They claimed that Dr. Jaiswal, as the ICU in-charge, ensured immediate care and that Mrs. Sunita was consulted by multiple specialists.
- They stated that the NCDRC erred in awarding compensation exceeding the actual medical bill.
- Dr. Shendre explained that the TT decannulation was necessary, and the NI procedure was chosen as a temporary stent to support the weakened trachea.
- They contended that choosing one treatment option over others does not amount to negligence.
- They argued that the complications could have arisen due to various factors and that there is no direct link with the NI procedure.
Submissions of the Parties
Main Submission | Sub-Submissions |
---|---|
Mrs. Sunita (Complainant) |
|
Dr. M.A. Biviji |
|
Dr. Nirmal Jaiswal, Dr. Madhusudan Shendre, and Suretech Hospital |
|
Issues Framed by the Supreme Court
The Supreme Court framed the following key issues for consideration:
- Whether the act of conducting the Nasotracheal Intubation (NI) procedure on Mrs. Sunita on 13 May 2004 at Suretech Hospital, while removing the existing Tracheostomy Tube (TT) after the bronchoscopy report indicated normalcy in Mrs. Sunita’s airways, amounts to negligence.
- If the answer to the above issue is in the affirmative, whether the subsequent medical complications in the form of permanent respiratory tract deformity as well as voice loss suffered by Mrs. Sunita can solely and directly be attributed to this single or specific negligent act.
Treatment of the Issue by the Court
The following table demonstrates as to how the Court decided the issues
Issue | Court’s Decision |
---|---|
Whether the NI procedure was negligent? | The Supreme Court held that the NI procedure was not negligent. The court reasoned that the procedure was a medically justifiable alternative chosen after the failure of TT decannulation and the discovery of a stridor. The court noted that the doctors at Suretech Hospital had valid reasons to opt for the NI procedure as a temporary measure to support the weakened trachea. |
Whether the subsequent medical complications were directly attributable to the NI procedure? | The court held that the subsequent medical complications, including permanent respiratory tract deformity and voice loss, could not be solely and directly attributed to the NI procedure. The court noted that Mrs. Sunita had received treatment at multiple hospitals, undergone several procedures, and had a prolonged period of intubation. The court also considered the expert medical committee report, which stated that such complications are common after serious road accidents and prolonged intubation. |
Authorities
The Supreme Court relied on the following authorities:
Cases:
- Jacob Mathew vs. State of Punjab [(2005) 6 SCC 1] – Supreme Court of India: This case was cited to define negligence and to set the standard for determining medical negligence. The Court emphasized that a doctor is not negligent if they follow a practice acceptable to the medical profession, even if a better alternative was available.
- Kusum Sharma vs. Batra Hospital [(2010) 3 SCC 480] – Supreme Court of India: This case was cited for the principles to be considered while determining medical negligence, including the need for a reasonable degree of skill and care, and that a difference of opinion does not constitute negligence.
- Savita Garg v. Director, National Heart Institute [(2004) 8 SCC 56] – Supreme Court of India: This case was cited to support the view that in cases of negligent treatment at a hospital, the burden to establish the absence of negligence lies on the hospital.
Legal Provisions:
- Section 23 of The Consumer Protection Act, 1986: This section was mentioned as the basis for filing the Civil Appeals against the NCDRC’s decision.
Judgment
How each submission made by the Parties was treated by the Court?
Party | Submission | Court’s Treatment |
---|---|---|
Mrs. Sunita | The forced NI procedure caused her complications. | The Court found that the NI procedure was a medically justifiable alternative, not a negligent act, and that the subsequent complications could not be solely attributed to the NI procedure. |
Dr. M.A. Biviji | He had no role in the NI procedure and the Barium Swallow Test was necessary. | The Court accepted his submissions, noting that he was a radiologist and the Barium Swallow Test was a routine procedure. |
Dr. Nirmal Jaiswal, Dr. Madhusudan Shendre, and Suretech Hospital | The NI procedure was not negligent and the complications were not linked to it. | The Court upheld their submissions, finding that the NI procedure was a medically justifiable alternative and that the subsequent complications could not be directly linked to it. |
How each authority was viewed by the Court?
- Jacob Mathew vs. State of Punjab [(2005) 6 SCC 1]: The Court used this case to define medical negligence and to emphasize that doctors are not liable for errors in judgment if they follow accepted medical practices.
- Kusum Sharma vs. Batra Hospital [(2010) 3 SCC 480]: The Court applied the principles from this case to assess whether the doctors’ conduct fell below the standards of a reasonably competent practitioner.
- Savita Garg v. Director, National Heart Institute [(2004) 8 SCC 56]: The Court referred to this case to highlight that the burden to prove lack of negligence is on the hospital.
What weighed in the mind of the Court?
The Supreme Court’s decision was primarily influenced by the following factors:
- Medical Justification of the NI Procedure: The Court found that the NI procedure was a medically justifiable alternative after the failure of TT decannulation and the discovery of a stridor. The doctors had valid reasons to opt for the NI procedure as a temporary measure to support the weakened trachea.
- Lack of Direct Causal Link: The Court concluded that the subsequent medical complications could not be solely and directly attributed to the NI procedure. The court noted that Mrs. Sunita had received treatment at multiple hospitals, undergone several procedures, and had a prolonged period of intubation.
- Expert Medical Opinion: The Court considered the RML Hospital Committee Report, which did not attribute any negligence to Suretech Hospital or its doctors. The report also stated that such complications are common after serious road accidents and prolonged intubation.
- Burden of Proof: The Court emphasized that the burden of proving medical negligence lies with the complainant, which Mrs. Sunita failed to establish.
- Medical Literature: The Court considered medical literature which stated that subglottic stenosis and tracheal trauma are not uncommon after serious road accidents and prolonged intubation.
Sentiment Analysis of Reasons Given by the Supreme Court
Reason | Percentage |
---|---|
Medical Justification of the NI Procedure | 40% |
Lack of Direct Causal Link | 30% |
Expert Medical Opinion | 15% |
Burden of Proof | 10% |
Medical Literature | 5% |
Fact:Law Ratio
Category | Percentage |
---|---|
Fact | 45% |
Law | 55% |
Logical Reasoning:
Issue: Was the NI procedure negligent?
Reason 1: TT decannulation failed, and stridor was observed.
Reason 2: NI was a medically justifiable alternative to support the weakened trachea.
Reason 3: No evidence of poor medical practice.
Conclusion: NI procedure was not negligent.
Issue: Were complications directly linked to the NI procedure?
Reason 1: Treatment at multiple hospitals, prolonged intubation.
Reason 2: Expert report: complications common after road accidents and intubation.
Conclusion: Complications not solely linked to NI procedure.
The Court considered alternative interpretations but rejected them due to the lack of evidence supporting negligence and the presence of medical justification for the chosen course of treatment. The Court also emphasized that medical practice is not an exact science and doctors should not be penalized for choosing one acceptable treatment over another.
The Court’s decision was based on a thorough analysis of the facts, medical records, and expert opinions, leading to the conclusion that the doctors at Suretech Hospital did not commit medical negligence.
“Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do or doing something which a prudent and reasonable man would not do.”
“A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.”
“The gap between what we know and what we aim for persists. And this gap complicates everything we do.”
Key Takeaways
- Burden of Proof: The judgment underscores that in medical negligence cases, the burden of proving negligence lies with the complainant.
- Medical Justification: Doctors are not negligent if they choose a medically justifiable alternative treatment, even if it does not yield the desired results.
- Causal Link: A direct causal link between the alleged negligent act and the subsequent complications must be established to prove medical negligence.
- Expert Opinion: The opinion of expert medical committees plays a crucial role in determining medical negligence.
- Contextual Analysis: Medical complications arising after serious accidents and prolonged treatment require a contextual analysis, and cannot be solely attributed to a single procedure.
- Human Fallibility: The judgment acknowledges the human element in medical practice, where doctors try their best but may not always achieve the desired results.
The judgment has significant implications for future medical negligence cases, emphasizing the need for concrete evidence and a thorough understanding of medical practices. It also highlights the importance of expert medical opinions in determining negligence.
Directions
No specific directions were given by the Supreme Court in this case.
Development of Law
The ratio decidendi of this case is that a medical professional cannot be held liable for negligence if they choose a medically justifiable alternative treatment, even if that treatment does not achieve the desired outcome, provided there is no breach of duty of care. The judgment reinforces the principle that the burden of proving medical negligence lies with the complainant.
This judgment clarifies that medical professionals should not be penalized for choosing one acceptable treatment option over another, and that a direct causal link between the procedure and the subsequent medical complications must be established to prove negligence. It also emphasizes the importance of expert medical opinions in determining medical negligence.
Conclusion
The Supreme Court overturned the NCDRC’s judgment, holding that the doctors at Suretech Hospital did not commit medical negligence. The Court found that the Nasotracheal Intubation (NI) procedure was a medically justifiable alternative chosen after the failure of Tracheostomy Tube (TT) decannulation and the discovery of a stridor. The Court also concluded that the subsequent medical complications could not be solely attributed to the NI procedure. The appeals filed by Dr. M.A. Biviji, Dr. Nirmal Jaiswal, Dr. Madhusudan Shendre, and Suretech Hospital were allowed, and the appeal filed by Mrs. Sunita was dismissed. The Court emphasized the importance of establishing a direct causal link between the alleged negligent act and the subsequent complications in medical negligence cases.
Category
- Consumer Law
- Medical Negligence
- Consumer Protection Act, 1986
- Medical Law
- Medical Malpractice
- Duty of Care
- Consumer Protection Act, 1986
- Section 23, Consumer Protection Act, 1986
Frequently Asked Questions (FAQs)
Q: What was the main issue in the case of M.A Biviji vs. Sunita & Ors.?
A: The main issue was whether the performance of a Nasotracheal Intubation (NI) procedure after a bronchoscopy indicated normal airways constituted medical negligence, and whether subsequent medical complications could be directly linked to this procedure.
Q: What was the Supreme Court’s verdict in this case?
A: The Supreme Court overturned the National Consumer Disputes Redressal Commission’s (NCDRC) finding of medical negligence. The court held that the NI procedure was a medically justifiable alternative and not a breach of duty of care.
Q: What is Nasotracheal Intubation (NI)?
A: Nasotracheal Intubation (NI) is a procedure where an endotracheal tube is inserted through the nose into the trachea to assist breathing.
Q: What is Tracheostomy Tube (TT)?
A: A tracheostomy tube (TT) is a tube inserted into a surgical opening in the trachea (windpipe) to provide an airway for breathing.
Q: What is a bronchoscopy?
A: A bronchoscopy is a procedure where a thin tube with a camera is inserted through the nose or mouth to examine the airways.
Q: What is a Barium Swallow Test?
A: A Barium Swallow Test is an X-ray procedure used to examine the upper digestive tract. The patient swallows a liquid containing barium, which makes the digestive tract visible on X-rays.
Q: What is the significance of the Jacob Mathew vs. State of Punjab case in this context?
A: The Jacob Mathew case was cited to define negligence and to set the standard for determining medical negligence. It emphasized that a doctor is not negligent if they follow a practice acceptable to the medical profession, even if a better alternative was available.
Q: What is the significance of the Kusum Sharma vs. Batra Hospital case in this context?
A: The Kusum Sharma case was cited for the principles to be considered while determining medical negligence, including the need for a reasonable degree of skill and care, and that a difference of opinion does not constitute negligence.
Q: What is the role of an expert medical committee in such cases?
A: The opinion of an expert medical committee is crucial in determining medical negligence. The committee’s findings help the court understand whether the medical treatment followed standard practices.
Q: What does the judgment mean for future medical negligence cases?
A: The judgment emphasizes the need for concrete evidence and a thorough understanding of medical practices in medical negligence cases. It also highlights the importance of expert medical opinions in determining negligence and clarifies that doctors should not be penalized for choosing a medically justifiable alternative treatment.
Q: What is the burden of proof in medical negligence cases?
A: The burden of proof in medical negligence cases lies with the complainant to establish that the medical professional’s conduct fell below the standards of a reasonably competent practitioner.
Q: What is the ratio decidendi of this case?
A: The ratio decidendi of this case is that a medical professional cannot be held liable for negligence if they choose a medically justifiable alternative treatment, even if that treatment does not achieve the desired outcome, provided there is no breach of duty of care. The judgment reinforces the principle that the burden of proving medical negligence lies with the complainant.
Source: M.A Biviji vs. Sunita & Ors.