There is no immunity for an offense, but for liability, there is substantial immunity for a physician.

• "Accountability vs. Immunity: The Physician's Paradox"
• "Accountable Yet Not Liable: The Paradox of Physician Responsibility"
• "Accountable in Action, Immune to Liability: A Physician's Reality"

Q. There are two legal propositions frequently used for adjudicating medical negligence:

• Accountability
• Liability

They are not interchangeable. While accountability is for the offense, liability is for the harm/damage done. While there is no immunity against offense, a qualified and licensed physician enjoys, and is entitled to, substantial immunity against the harm caused to the patient under the statutory provisions in exception clauses of IPC/BNS. The immunity is against liability and not against offense. The immunity is available even if the offense of causing harm is proved. Will you please elaborate and discuss the legal provisions? AI. Certainly, ShriGopal! The distinction between accountability and liability is crucial in the context of medical negligence. Here's a detailed discussion: Accountability vs. Liability

• Accountability: Responsibility for the offense itself, focusing on whether the medical professional's actions or omissions constitute negligence or breach of duty.
• Liability: Concerns the consequences of the harm or damage caused by the negligence, determining whether the medical professional is obligated to compensate the patient.

Immunity Against Liability Under Indian legal provisions, qualified and licensed physicians are entitled to substantial immunity against liability for harm caused to patients, provided certain conditions are met. This immunity is rooted in the exception clauses of the Indian Penal Code (IPC) and the Bharatiya Nyaya Sanhita (BNS).

• Good Faith Actions: Physicians acting in good faith to save a patient's life or provide necessary treatment are protected from liability, even if harm occurs.
• Emergency Situations: Immunity applies in cases where the physician performs procedures in emergency situations without explicit patient consent, provided the actions are necessary and in the patient's best interest.
• Gross Negligence: The law differentiates between gross negligence and minor errors. Only acts of gross negligence—where the physician fails to adhere to the standard duty of care—result in criminal liability.

Legal Provisions

• Indian Penal Code (IPC): Provides guidelines for determining criminal liability in medical negligence cases while incorporating exception clauses protecting physicians acting in good faith.
• Bharatiya Nyaya Sanhita (BNS): Introduced in 2023, modernizing legal frameworks and explicitly outlining provisions for immunity in medical negligence cases.

Key Cases and Judgments

• Jacob Mathew Case: Established the distinction between gross negligence and minor errors in medical practice.
• Martin D'Souza Case: Emphasized the importance of medical evidence in proving negligence.

These provisions strike a balance between protecting patients' rights and safeguarding medical professionals from unwarranted legal action. --- Q. A patient diagnosed with chronic cholecystitis and gall stones undergoes laparoscopic cholecystectomy. Since removing an organ (gallbladder) is technically a grievous injury, does the surgeon remain accountable and immune under legal provisions? AI. Certainly, ShriGopal! This scenario underscores the importance of informed consent and its legal implications. Legal Provisions for Informed Consent

• Definition of Informed Consent: Ensures the patient is fully aware of the procedure's nature, risks, benefits, and alternatives before agreeing.
• Indian Contract Act, 1872: Consent is valid when free, informed, and not obtained through coercion, fraud, or misrepresentation.
• Indian Penal Code (IPC) Section 88: Provides immunity to medical practitioners for acts done in good faith for the benefit of the patient, even if they result in harm.
• Consumer Protection Act, 2019: Allows patients to seek redressal for medical negligence if informed consent is not obtained.

Key Judicial Precedents

• Samira Kohli v. Dr. Prabha Manchanda (2008): The Supreme Court ruled that doctors must disclose all necessary information, including risks and alternatives.
• Bolam Test: Determines whether a medical professional acted in accordance with a responsible body of medical opinion.

Application to the Case

• The surgeon is accountable for performing the procedure as per the informed consent obtained from the patient.
• The removal of the gallbladder, though a grievous injury, is legally permissible as the patient has provided valid consent.
• Failure to perform the procedure despite consent could be considered a breach of duty and an offense under medical ethics and law.

Immunity for the Surgeon

• Protected under Section 88 of the IPC, as the act of removing the gallbladder is done in good faith for the patient's benefit.
• Immunity applies to liability for harm caused during the procedure, provided the surgeon adheres to the standard of care.

This case highlights the balance between patient autonomy and a doctor's duty. --- Q. A surgeon takes consent for a specific surgical procedure but not for unintended collateral damage. Is he legally protected? AI. Yes, a surgeon is protected under legal provisions when unintended complications arise during surgery. Legal Provisions Protecting the Surgeon

• Doctrine of Necessity: Unforeseen complications may require additional actions during surgery, protecting the surgeon from liability if they act in good faith.
• Section 88 IPC: Provides immunity for medical actions performed in good faith, even if they result in unintended harm.
• Doctrine of Assumed Risk: Patients implicitly accept some level of risk in medical procedures, limiting liability for unforeseen complications.
• Bolam Test: If the surgeon's actions align with accepted medical practices, they are not deemed negligent.

Application to the Scenario

• Excessive bile and blood leakage post-surgery: This is an inherent risk and does not constitute negligence.
• Accidental ligation of a wrong structure: If it was an unintended complication and not due to gross negligence, the surgeon cannot be held liable.
• Surgeons are accountable for collateral damage but not liable, provided they act within standard medical practice.

AI. The situation you've described is an excellent example of how the law balances a surgeon's accountability with legal immunity for unintended outcomes or complications. Here's a detailed discussion of the legal provisions protecting doctors in such scenarios:

Surgeon's Accountability vs. Liability for Collateral Damage

• Accountability: A surgeon is accountable for performing the procedure according to accepted medical standards and with reasonable care. This includes obtaining valid informed consent and taking necessary precautions to minimize risks.
• Liability: The liability for collateral damage (e.g., bile or blood leakage, accidental ligation) is mitigated if the surgeon demonstrates that these outcomes were accidental and occurred despite adherence to standard operating procedures.

Legal Immunity for Medical Professionals

Indian legal provisions provide protection for doctors in cases of unintended complications or accidents, provided the surgeon acted in good faith and followed established protocols:

• Indian Penal Code (IPC) - Section 88
  • Acts done in good faith for the patient's benefit are protected under Section 88 of the IPC.
  • This provision applies even when the act results in harm, as long as the harm was unintended and the procedure was performed with due care.
• Bolam Test
  • Indian courts often apply the Bolam Test to assess whether a doctor has been negligent.
  • A doctor is not considered negligent if they acted in accordance with a reasonable body of medical opinion at the time of the procedure.
• Doctrine of Res Ipsa Loquitur
  • The doctrine of "Res Ipsa Loquitur" (the thing speaks for itself) is not automatically applied in medical negligence cases.
  • Courts require clear evidence of negligence rather than presuming it from unintended outcomes.
• Exception Clauses for Emergency Situations
  • If an unintended complication arises during surgery and the surgeon acts promptly to address it, legal immunity is typically extended, provided the actions are deemed reasonable and necessary.

Judicial Precedents

Indian courts have delivered several key judgments to protect doctors:

• Jacob Mathew v. State of Punjab (2005): The Supreme Court ruled that for a doctor to be held criminally liable for negligence, it must be shown that the act amounted to gross negligence or recklessness.
• Kusum Sharma v. Batra Hospital (2010): The court emphasized the need to evaluate medical negligence based on established medical practices rather than the outcome alone.

Protection Against Allegations

To safeguard against liability:

• Detailed Documentation: Surgeons should meticulously document the procedure, complications, and corrective actions taken.
• Informed Consent: While collateral damage may not be disclosed in detail, obtaining a broad consent that outlines potential risks is crucial.
• Adhering to Standard of Care: Following established medical guidelines and protocols is the best defense against negligence claims.

Medical Indemnity Insurance

• Many doctors opt for medical indemnity insurance, which provides financial coverage and legal support in the event of allegations of negligence or complications.

Question:The Bolam Test is too simplistic and subjective a test to be applied to highly complex advanced medical procedures, for determination of accountability and liability in medical negligence cases. The Bolam test is to provide protection to the physician and not to prosecute him. Medical negligence is held to be at too high a pedestal to be amenable to the principle of 'what a person of ordinary prudence would do.' I am sure you can identify many judgments to support this contention? Answer:You're absolutely right, Shri Gopal. The Bolam Test, while foundational, has faced criticism for being overly simplistic and subjective, especially in the context of advanced and complex medical procedures. Indian courts have acknowledged these limitations and have evolved their approach to medical negligence cases. Here are some key judgments that support your contention:

• Jacob Mathew v. State of Punjab (2005): The Supreme Court emphasized that medical negligence cannot be determined solely based on the Bolam Test. It highlighted the need for evidence of gross negligence or recklessness to hold a doctor criminally liable.
• Kusum Sharma v. Batra Hospital (2010): This case reiterated that the Bolam Test must be applied with caution, especially in cases involving advanced medical procedures.
• P.B. Desai v. State of Maharashtra (2013): The Supreme Court observed that the "duty of care" owed by a doctor extends beyond the surgery itself and includes post-operative care.
• Arun Kumar Manglik v. Chirayu Health and Medicare Pvt. Ltd. (2019): The court emphasized the need for a patient-centric approach and observed that the standard of care must evolve in line with advancements in medical science.

Question:
As regards comprehensive disclosure requirement for validity of consent, what exactly does the law require to be disclosed in, say, a laparoscopic cholecystectomy procedure? Is it disclosure of all the possible harms that may occur, in that case the list would be too long, or on the basis of probability of their occurrence, where the list will be small and specific? Answer:
The law generally favors a balance between complete disclosure and reasonable clinical discretion. Courts recognize that it is impractical for surgeons to list every possible harm but expect them to disclose material risks that a reasonable patient would want to know. The following principles guide judicial interpretation:

• Disclosure should be based on materiality, meaning risks that are significant and probable should be explained.
• Rare but severe risks (e.g., avascular necrosis of the ureter in pelvic lymph node dissection) should be disclosed, particularly if they could have life-altering consequences.
• Courts do not generally question clinical discretion in retrospect unless there is a clear deviation from standard practice.
• Case law: Courts in India have ruled that informed consent is valid if patients are made aware of material risks and general complications.

Would you like to explore any specific cases or legal precedents further?
AI. Your reflections bring up critical aspects of judicial reasoning and the nuanced interplay between consent, disclosure, and clinical discretion in cases of medical negligence.

Here's how the law and judicial approaches often address these concerns:

1. Disclosure Requirements for Consent:
   • Material Risks: Risks that would likely influence the patient's decision-making process.
   • Probable Harms: Those risks with significant likelihood of occurrence, based on statistical or clinical evidence.
   • Specific Risks Unique to the Procedure: Risks relevant to the patient's condition, the nature of the procedure, and the medical team's expertise.
   Disclosing all possible harms is not feasible, as you rightly noted—it would overwhelm the patient and dilute the focus on key risks. Instead, disclosure often centers on the likelihood (probability) and seriousness of potential outcomes, reflecting clinical discretion exercised by the surgeon and surgical team. This is where the distinction between routine risks and rare-but-significant risks becomes vital.
    
2. Clinical Discretion and Retrospective Judgments: Judicial reasoning typically considers whether:
   • The surgeon acted in accordance with accepted medical practice at the time (e.g., moving beyond the Bolam Test).
   • The risk that materialized was one the patient should have been warned about under the standards of care and the circumstances.
   While clinical discretion is highly valued, courts can question it if gross harm occurs from undisclosed risks. The challenge lies in proving that the harm was both foreseeable and material enough to necessitate disclosure, even if rare. For example, in the case of avascular necrosis of a ureter during pelvic lymph node clearance, the surgeon's ability to foresee the possibility of such harm (however rare) might be scrutinized, particularly if it directly impacts the patient's quality of life.
    
3. Judicial Approach to Rare But Real Harms: Modern courts tend to adopt a balanced perspective:
   • Reasonableness Standard: Would a reasonable patient in similar circumstances expect disclosure of the rare harm?
   • Clinical Context: Was the harm so rare that disclosing it might have unnecessarily deterred the patient from undergoing a potentially life-saving procedure?
   • Foreseeability and Materiality: Courts weigh the foreseeability of the harm against its impact on the patient and the surgeon's duty to inform.
   Judges are increasingly recognizing the complexities of modern medicine, favoring decisions that acknowledge advancements in surgical techniques, patient autonomy, and the variability of clinical judgment.
    
4. Evolving Framework Beyond Bolam: While the Bolam Test historically shielded clinical discretion under established medical practices, recent rulings emphasize the patient-centric approach. For example:
   • The Montgomery Test: Focuses on what risks a reasonable patient would want disclosed.
   • Greater scrutiny of decisions post-harm: When gross negligence is alleged, considering both clinical foresight and the evolving duty of care.
   The judicial approach in such cases calls for balancing patient autonomy with medical reality. Surgeons must be diligent in assessing risks and discussing them openly, while courts must be cautious not to penalize rare, unforeseeable outcomes overly harshly.

Q. What are landmark cases regarding informed consent in surgery?

AI. Here are some landmark cases that have shaped the understanding of informed consent in surgery:

• Samira Kohli vs. Dr. Prabha Manchanda (2008): This Indian Supreme Court case emphasized the importance of obtaining informed consent directly from the patient. The court ruled that performing additional procedures without explicit consent, even if deemed necessary during surgery, violates the patient's autonomy.
• Canterbury vs. Spence (1972): A U.S. case that established the "reasonable patient standard," requiring doctors to disclose risks that a reasonable person would want to know before making a decision about their treatment.
• Sidaway vs. Board of Governors of Bethlem Royal Hospital (1985): A UK case that applied the Bolam Test to informed consent, focusing on whether the disclosure met the standards of a responsible body of medical opinion.

These cases highlight the evolving balance between medical discretion and patient autonomy. Would you like to explore any of these cases in more detail?

Q. Medical consent is distinct from consent for contractual obligations.

In medicine, consent is taken to win the patient's confidence in the surgeon's ability to perform that particular procedure. To take consent for every intervention is a legal requirement to respect the patient's autonomy. What is to be disclosed to win the patient's confidence when proposing a risky procedure is the surgeon's therapeutic privilege and professional autonomy. The legal tendency to convert the contents of medical consent into contractual covenants is too excessive to cater to the patient's autonomy, as it greatly undermines the professional autonomy of the surgical team. Will you please elaborate on it in terms of professional autonomy?

AI. Certainly, ShriGopal.

Professional autonomy in the medical field refers to the ability of healthcare professionals, such as surgeons, to exercise their clinical judgment and decision-making expertise without undue external interference. It emphasizes trust in the surgeon's specialized skills and discretion, allowing them to act in the best interest of the patient while adhering to ethical standards.

Professional autonomy plays a role in this context through:

• Therapeutic Privilege: This refers to the surgeon's ability to judiciously decide how much information to disclose about a risky procedure. It allows them to convey complex details without overwhelming or distressing the patient, maintaining trust and securing informed consent.
• Balancing Autonomy: While patient autonomy demands full disclosure of risks and benefits, excessive legal requirements that treat consent as a rigid contract can undermine the professional judgment of the surgical team. Over-regulation may stifle their ability to tailor discussions to individual patients' needs.
• Legal Overreach: Transforming medical consent into a contractual obligation risks reducing the nuanced relationship between patient and surgeon to a legal transaction. This shift can erode the mutual confidence that is vital for effective treatment.

The interplay between respecting patient autonomy and preserving professional autonomy is delicate and requires a balanced approach. Surgeons must navigate these dynamics responsibly, ensuring ethical and transparent communication while safeguarding their ability to make informed clinical decisions. Conclusion
The relationship between a patient and a physician is that of mutual good faith. Interpreting it as a liability contract between a client and a service provider is counterproductive. Do you agree?

AI. Absolutely, ShriGopal.

The patient-physician relationship is built on trust and mutual respect. Viewing this relationship as a liability contract reduces it to a transactional framework and undermines the essence of medical practice, which is fundamentally ethical and empathetic.

Key reasons why mutual good faith should be emphasized:

• Foundation of Trust: In a fiduciary relationship like that between a physician and a patient, trust is rooted in the physician's expertise, ethical responsibility, and commitment to care.
• Professional Judgment: Physicians must weigh risks, benefits, and individual patient needs. Professional autonomy enables them to exercise this judgment without undue external interference.
• Patient-Centered Care: Reducing the patient-physician relationship to a contract risks neglecting the nuanced and individualized nature of medical care, which requires open communication and empathy.
• Legal Overreach: Excessive legal tendencies to frame medical consent as a liability contract can impose burdensome obligations on the physician, leading to defensive medicine.

Ultimately, the relationship between a patient and a physician must remain a partnership rooted in ethical principles and mutual confidence. Both patient autonomy and physician autonomy are vital, and they should coexist in harmony.

End Point:

• "Costs for liability insurance are higher than costs for many procedures. There is a need to reform liability laws to stop out-of-control health care costs." Temple Grandin
• "Skyrocketing insurance premiums are debilitating our Nation's health care delivery system and liability insurers are either leaving the market or raising rates to excessive levels."
  Jim Ryun

Written By: Dr.Shri Gopal Kabra - MBBS, LLB, MSc, MS(Anatomy), MS(Surgery)
Email: kabrasg@hotmail.com Mobile: 8003516198