The complexities and challenges in evaluating medical negligence cases need attention of the judiciary. The intersection of law and medicine presents unique difficulties, particularly when legal principles are applied to the nuanced and often subjective practice of medicine.

Q. Like codified statutory laws, there are codified medical-practice schedules. And like uncodified Common Law and Law of Natural Justice, there is uncodified medicine where experience based empirical decisions are made. The two are covered respectively under 'Evidence Based Medicine' and "Empirical Medicine'. The two are complementary, like the two sets of laws, and not exclusionary. All medical decisions are judgmental based on the experience of practice of codified medicine in which the physician is trained.

The difficulty and the dilemma in medical negligence cases is, that the legal principles (criteria) evolved and applied in uncodified laws to evaluate medical negligence cases are abstract and intangible to those practicing the practical science of medicine. Take for instance 'standard care' where neither 'standard' nor 'care' are defined. The same holds good for 'competence and caution'.

The semantic adjectives added to each of these undefined legal criteria further confuse the medical pratitioner. In practice of medicine the set standards are in form of STGs (Standard Treatment Guidelines), SOPs (Standard Operative Procedures), CPs (Clinical Protocols), CPWs (Clinical Pathways) and CrPWs (Critical Pathways). Your comments please
Response: You've raised some very insightful points about the complexities and challenges in evaluating medical negligence cases. The intersection of law and medicine indeed presents unique difficulties, particularly when legal principles are applied to the nuanced and often subjective practice of medicine. Key Points to Consider:

• Codified vs. Uncodified Systems:
  • Evidence-Based Medicine (EBM): This relies on codified guidelines like STGs, SOPs, CPs, CPWs, and CrPWs. These provide a structured approach to medical practice, aiming to standardize care based on the best available evidence.
  • Empirical Medicine: This is more flexible and relies on the physician's experience and judgment. It allows for individualized patient care, which can be crucial in complex or atypical cases.
• Legal Criteria in Medical Negligence:
  • Standard of Care: The legal system often struggles with defining what constitutes a "standard of care" because it can vary widely depending on the context, location, and available resources. In medicine, this is typically guided by the aforementioned protocols and guidelines.
  • Competence and Caution: These terms are indeed abstract and can be interpreted differently. In legal terms, they often require expert testimony to establish whether a physician's actions were within the bounds of what is considered competent and cautious practice.
• Semantic Challenges:
  • The legal language used to describe medical negligence can be vague and open to interpretation. This can lead to confusion and inconsistency in judgments. For instance, what one court considers "reasonable care" might differ from another's interpretation.

Global Best Practices:

• New Zealand's No-Fault System: New Zealand employs a no-fault compensation system for medical injuries, which focuses on providing compensation without the need to prove negligence. This system aims to reduce the adversarial nature of medical negligence claims and focuses on patient recovery and safety improvements.
• Expert Panels: Some countries use expert panels to review medical negligence cases. These panels consist of medical professionals who can provide a more informed perspective on whether the standard of care was met.
• Continuous Professional Development: Ensuring that medical professionals are up-to-date with the latest guidelines and practices can help mitigate negligence claims. Regular training and assessments can reinforce the importance of adhering to established protocols.

Moving Forward:

• Clearer Guidelines: There is a need for clearer, more universally accepted guidelines that can bridge the gap between medical practice and legal expectations.
• Interdisciplinary Collaboration: Greater collaboration between legal and medical professionals can help develop more practical and fair criteria for evaluating medical negligence.

Your perspective as a medical professional is crucial in these discussions. How do you think the legal system could better accommodate the realities of medical practice?

Q. The medical standards specific to each case are codified in STGs, SOPs and CPs. Courts should consider them instead of undefined legal standards.
STGs are State developed guidelines for primary diseases at primary health care centers. Most of the States in India have such guidelines for their primary physicians.

SOPS are authorized directions for all activities (administrative) in the hospital other than actual treatment. SOPs are not guidelines but policy mandates to be followed in word and spirit. Accreditation Board and Regulating Agencies prescribe and mandate the same. All SOPs are available with hospital administration.

CPs are disease and medical situation based guidelines for the treating physicians. These are the sheet anchor of all treatment modalities. They are developed by the regulating agencies, International and National, Research and Education, and prescribed in text books. They are regularly updated and changed on the basis of feedback from researchers and clinicians. There are International Agencies that review and recommend. Text books are edited and revised accordingly. CPs cover all the known variables as far as possible and incorporate medical algorithms to vary and tailor the treatment. The rest is left to the clinical judgment of the trained physician in the light of response to the treatment. Standard treatment does not always have a standard patient response. In surgery, possibility of unintended injury (risk) to structures in the field of operation, emerging from experience, are documented in the text books, and how such unintended injuries are to be avoided becomes a part of recommended surgical procedure and part of physician's training. Disease pathology often alters the normal anatomy of the diseased part making the surgeon's work difficult. The surgeon has to feel his way through. Every case is learning exercise for a surgeon that enhances his skill. The same is true for physicians. A surgeon or a physician enjoys wide flexibility in treating a patient.

Clinical Pathways are hospital policy guidelines for time and sequence based approach for package cases where treatment is offered in elective cases against a single payment for the defined services in the package.

Critical pathways are time sequenced interventions in critical life threatening situations such as cardiac arrest (code blue). Teams are trained and emergency codes are assigned for the team to immediately rush to the location when the code is announced on the intercom.

They are never taken into consideration in adjudicating a case of medical negligence particularly in the affidavit based summary trial under CPA.

Response: You've provided a comprehensive overview of the various medical standards and guidelines that should be considered in medical negligence cases. Your points highlight the structured and evidence-based nature of medical practice, which contrasts with the often abstract legal criteria used in courtrooms.

Key Medical Standards:

1. Standard Treatment Guidelines (STGs):
   • Developed by state authorities for primary diseases at primary health care centers.
   • Provide a standardized approach for primary physicians, ensuring consistency in care.
2. Standard Operative Procedures (SOPs):
   • Policy mandates for administrative activities in hospitals, not directly related to treatment.
   • Enforced by accreditation boards and regulatory agencies, ensuring compliance with established policies.
3. Clinical Protocols (CPs):
   • Disease and situation-specific guidelines for treating physicians.
   • Developed and regularly updated by international and national regulatory agencies, research institutions, and educational bodies.
   • Incorporate medical algorithms to tailor treatment to individual patient responses, allowing for physician judgment and flexibility.

Legal Considerations:

• Standard of Care: Courts should indeed consider these codified medical standards (STGs, SOPs, CPs) rather than relying on undefined legal standards. This would provide a more concrete basis for evaluating whether the care provided met the expected standards.
• Competence and Caution: These terms should be interpreted in the context of the specific medical guidelines relevant to the case. Expert testimony from medical professionals familiar with these guidelines can help clarify whether the actions taken were appropriate.

Challenges in Surgery and Medicine:

• Surgical Complexity: As you mentioned, disease pathology can alter normal anatomy, making surgical procedures more challenging. Surgeons must rely on their experience and judgment to navigate these complexities, and unintended injuries, while unfortunate, can occur despite adherence to best practices.
• Physician Flexibility: Both surgeons and physicians must adapt their approaches based on patient responses and evolving medical knowledge. This flexibility is crucial for effective treatment but can complicate legal evaluations of negligence.

Moving Forward:

• Integration of Medical Standards in Legal Proceedings: Encouraging courts to consider established medical guidelines and protocols can lead to more informed and fair judgments in medical negligence cases.
• Expert Involvement: Involving medical experts who understand these guidelines can bridge the gap between legal and medical perspectives, ensuring that evaluations of negligence are grounded in the realities of medical practice.

Your insights are invaluable in advocating for a more nuanced and informed approach to handling medical negligence claims. How do you think these ideas could be practically implemented in the legal system?

Discussion: Now, even when the relevant authentic text of any of the above standards is submitted, the judge lacking basic knowledge of medicine, would need expert help to decipher and understand its intricate details. There should be provision for mandatory expert input to brief the judge about the case.

The criteria of standard care ' what an ordinary person of ordinary prudence would do or refrain from doing in the same situation' is too simplistic, abstract and subjective to be applied to the very vast complex field of medical practice. What a prudent physician would or should do is what is defined in clinical protocol for the case.

As regards seeking expert help, the matter can always be referred to a Medical Board of a Medical College or Government hospital to analyze the chronological medical record and help the court to objectively adjudicate. All courts have the power to requisition it. The disputing litigants should be asked to submit expert opinion to support their submissions.

Established comprehensive medical protocols for various aspects of medical practice help in standardizing care and reducing the risk of legal issues arising from clinical decisions. These protocols can serve as a reference for both medical professionals and legal entities in assessing the appropriateness of care provided

Conclusion: National Medical Commission (formerly Medical Council of India) that ensures medical competence of all medical specialists, and by granting them license to practice the specialty in which they were trained, per the NMC standards, assures the public that the licensed professional possesses all the knowledge and skill (competence) to practice the licensed profession, should take responsibility to protect their licensees against judicial and public excesses. Medical protocols for every aspect of medical practice are there.

Standard of care, as per judicial perception, is too nebulous a concept. With millions of real-time situations, and thousands and thousands of treatment modalities, what would constitute a standard medical modality in a specific case is the real time decision of the treating physician. Legal principles of standard of care, being intangible, do not translate into medical standards. What is standard treatment is a matter of clinical decision of the treating physician in the real-time situation. The judgment may, in retrospect, prove to be wrong. Error of judgment is no crime. In medical treatment every act of the physician is judgmental.

Written By: Dr. hri Gopal Kabra, MBBS, LLB, MSc, MS(Anatomy), MS(Surgery)
Ph no: 8003516198