Abstract
The NEET 2024 examination witnessed around 24 lakh applicants, highlighting India’s profound interest in the medical profession. This paper explores the intersection of law and medicine in India, analyzing how legal frameworks shape healthcare delivery to ensure justice while maintaining high standards of care. It scrutinizes the rise of frivolous legal proceedings against medical professionals and their impact on medical decision-making. The paper examines landmark case laws and compares the new Bharatiya Nyaya Sanhita (BNS) with the Indian Penal Code (IPC) to reveal their effects on governing medical negligence cases. By highlighting the need to protect medical professionals from baseless lawsuits, the paper underscores the importance of balancing accountability with the freedom to practice medicine. Recommendations for legal reform, such as clearer definitions of negligence and enhanced patient-professional communication, are proposed to ensure a just and fair legal environment conducive to high-quality healthcare.
Keywords – Medical negligence, defensive medicine, gross negligence, duty of care, BNS
Research methodology– This study is a qualitative research paper using secondary sources to explore the impact of fear of legal proceedings, particularly ‘medical negligence claims’ that affects medical professionals. The research aims to analyze how laws shape healthcare delivery, and the impact of legal proceedings on medical professionals. The research compares the new Bharatiya Nyaya Sanhita (BNS) with the Indian Penal Code (IPC) provisions on medical negligence. The secondary sources include academic journals, articles, newspaper articles, online websites like JSTOR, Google Scholar, provisions of IPC and BNS, etc.
Literature Review
Medical Negligence
Medical negligence, a prominent issue in healthcare law, refers to deviations from standard practices by healthcare providers, resulting in harm to patients. It impacts patient safety, medical accountability, and has legal impacts. Research states the complexities involved in defining and proving negligence, requiring expert testimony and adherence to established care standards. Landmark cases like Dr. Suresh Gupta v. Govt. of NCT of Delhi and Jacob Mathew v. State of Punjab gives the standards for proving criminal medical negligence. Understanding medical negligence is essential for legal reforms that balance patient rights with healthcare professionals’ responsibilities.
Gross negligence
The literature on gross negligence in Indian medical law highlights the legal ramifications of not having a clear definition. Key cases include Dr. Suresh Gupta v. Govt. of NCT of Delhi, where the court held that criminal liability requires a high standard of negligence, often termed gross negligence. The Jacob Mathew v. State of Punjab case further refined this, affirming that gross negligence must involve a significant breach of duty beyond mere error. These cases highlight the necessity for clear legal standards to differentiate between professional errors and criminal negligence, emphasizing that only rarest of the rare deviations from accepted medical practice warrant criminal treatment.
Defensive medicine
Defensive medicine, prevalent in healthcare, involves doctors conducting unnecessary tests and procedures primarily to protect themselves from litigation, rather than for patient benefit. Studies highlight its adverse impact on healthcare costs, patient well-being, and overall healthcare efficiency. This practice, rooted in fear of legal repercussions, shows the interconnectedness between medical practice and legal liability. Efforts to mitigate defensive medicine involve legal reforms, clearer guidelines on negligence, and fostering a supportive legal environment that balances accountability with enabling effective patient care.
Duty of care
The concept of duty of care is fundamental in tort law, establishing the obligation of individuals and organizations to exercise reasonable care to avoid causing harm to others. The literature traces its historical development and examines the policy considerations shaping its legal obligation. Emphasizing the need to have a balanced approach,existing precedents highlight the importance of considering the interests of both parties to ensure fairness. The duty of care, as a concept, has evolved to address societal changes, promoting the societal need and public good.
BNS
The new Bharatiya Nyaya Sanhita (BNS) Act introduces significant changes to the legal landscape governing medical negligence in India. Under Section 106, it mandates stricter penalties, including mandatory imprisonment, for medical practitioners found guilty of negligence resulting in patient death. This legislative reform has sparked widespread debate and criticism within the medical and legal community, as seen in news articles and videos, citing concerns over ambiguous wording, potential misuse in litigation, and its perceived impact on professional autonomy. Medical professionals plead for clarity in legal definitions, safeguards against unjust prosecution.
This paper addresses the gap in research by comparing the new criminal law, Bharatiya Nyaya Sanhita (BNS) with the Indian Penal Code (IPC) regarding medical negligence, highlighting doctors’ protests, and examining how the fear of litigation prompts defensive medical practices. It contributes to understanding the legal landscape’s impact on healthcare, emphasizing the need for balanced reforms to protect both patients and medical professionals.
Introduction
Medical negligence constitutes the nucleus of medical law, with its roots tracing back to the Code of Hammurabi in ancient Babylonia. Originally established to protect the public from malpractice by doctors and physicians and to ensure bodily autonomy, medical negligence has evolved significantly over the centuries. Negligence can be defined as the breach of a duty, either by omission—failing to do something a reasonable person of ordinary prudence would do—or by commission—doing something that a prudent person would not do. Medical negligence is categorized into civil and criminal negligence, distinguished by the degree of negligence and intent. Criminal medical negligence requires the presence of mens rea, meaning there must be malicious intent or a level of negligence and recklessness significantly higher than that required for civil liability, amounting to gross negligence. The rise in medical negligence cases can be credited to increased patient rights awareness, notably amplified by the Consumer Protection Act’s inclusion in the 1990s, triggering a rise in legal actions against doctors.
The criticism
Issues regarding the breach of patient rights frequently emanate from scenarios involving medical professionals, particularly in India’s context where the private healthcare sector grapples with a lack of regulation and the public healthcare system is hampered by sub-par infrastructure. There are many individuals who do not possess the qualification or certification and yet are administering healthcare to citizens. It is crucial to draw a distinction between medical negligence, characterized by the non-fulfillment of prevailing standards of care that is followed by a man of ordinary prudence, and medical malpractice, which implies when the healthcare provider fails to follow appropriate guidelines or rules. This paper confines its analysis to the domain of medical negligence.
Comparative study
Medical negligence laws vary across different countries. In the United States, medical negligence is mainly governed under tort law and civil liabilities, where plaintiffs have the burden of proof for proving negligence of the medical professional under “preponderance of evidence” standard. The U.S. legal system allows for monetary compensation, including punitive damages, which ultimately increase defensive medicine practices. In contrast, in the United Kingdom, medical negligence is governed by the National Health Service (NHS) and civil courts. The Bolam test, developed in the UK, is a key standard for determining the standard of care and is followed globally, including in India. According to the Bolam test, a doctor is not considered negligent if their actions are supported by a reliable body of professional medical opinion. The burden of proof is on the claimant, and compensation is based on the severity of the harm or negligence caused to the patient. Select countries, like Sweden and New Zealand, have adopted no-fault systems where compensation is awarded based on severity of the injury.
In India, medical negligence cases were historically governed by the Consumer Protection Act and the Indian Penal Code (IPC) Section 304A. However, the recent introduction of the Bharatiya Nyaya Sanhita (BNS) under Section 106 raises concerns about its impact on medical practice due to new punishments, ambiguous wording, and the perceived lack of protection for doctors. While India criminalizes medical negligence, in the US and UK, medical professionals convicted under medical negligence are often charged with involuntary manslaughter, which means causing death without malicious intent or lack of mens rea.
Judicial Perspective in India
How effective can the Hippocratic Oath truly be when doctors bear the full weight of scrutiny whenever outcomes go awry? The Delhi High Court recently highlighted the importance of medical experts being able to provide reasoned opinions without fearing legal repercussions. In this case, a woman was seeking a medical termination of pregnancy (MTP) upon discovering that her unborn fetus was diagnosed with Joubert syndrome, which the Lok Nayak Hospital had denied. The court, presided over by Justice Sanjeev, expressed dissatisfaction with the initial report from Lok Nayak Hospital’s medical board, deeming it inconclusive and unreliable. Furthermore, the court sought further evaluation from the AIIMS medical board. The AIIMS medical board verified the MTP request, confirming the presence of significant abnormalities in the pregnancy. This reflects a persistent issue in our medical system. Medical boards must swiftly and accurately provide reports, offering precise information to vulnerable patients. It reiterates the judicial system’s crucial role in ensuring that expert medical opinions are safeguarded from undue legal challenges.
Fear of litigation and Defensive Medicine
The fear of litigation drives doctors to act defensively, performing unnecessary diagnostic tests and going through unnecessary treatments and hospitalization of patients —a phenomenon known as defensive medicine. It is defined as physicians prescribing investigations, procedures, referrals, or other evasive steps to protect themselves from legal liability under medical malpractice.
Studies by Studdert in the US revealed that 92% of surveyed physicians in the US ordered unnecessary tests for confirmation, and 42% avoided treating high-risk patients or patients with complications due to legal concerns. A Harvard study confirmed that most physicians were performing defensive medicine These show the rising prevalence of defensive medicine and how the fear of litigation plays a prominent role in the way medicine is practiced. Defensive medicine raises the cost of healthcare and often puts a financial burden on the patients. Performing unnecessary tests as a protective mechanism is not efficient, practical nor sustainable.
Defensive medicine has led to many unintended consequences. In practicing defensive medicine, it has been noticed that doctors hand out antibiotics frivolously, thereby contributing to the growing antibiotic resistance in patients. In Turkey, gynecologists are reportedly avoiding critical cases due to defensive strategies, while a Florida hospital saw a rise in C-sections deliveries over vaginal births, linked to medical liability fears. In the case of Martin F. D’ Souza vs. Mohd. Ishfaq, the court gave the example of heart attack patients who received medications such as morphia and pethidine injections, considering the urgency of the matter. However, due to the threat of legal action, doctors have become hesitant to administer such medications, even during emergency situations, fearing legal proceedings if the patient does not survive. The reality is that doctors are not magicians or divine beings with life-saving powers. A mistake made under normal circumstances cannot be equated with negligence. Doctors and other medical professionals deserve to be protected to ensure that they are allowed the freedom to suggest the best possible cure or remedy as each situation demands.
The Impact of Legal Scrutiny on Medical Practice
Civil courts have traditionally been the primary method for resolving medical negligence claims in India. The landmark case of the Indian Medical Association v. V. P. Shantha brought medical negligence under the ambit of the Consumer Protection Act of 1986. Criminal liability for medical negligence was defined under section 304A of the Indian Penal Code (IPC) 1860, which states: “Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.” However, the terms ‘rash’ and ‘negligent’ are not explicitly defined in Section 304A or any other section of the IPC, leaving their interpretation to the discretion of the court and the medical board. Additionally, Sections 52, 80, 81, 88, 90, 91, 92, 336, 337, and 338 of the IPC have also been employed in cases related to criminal medical malpractice.
In the case of Dr. Suresh Gupta v. Govt. of NCT of Delhi, the court held that for fixing criminal liability in medical negligence cases, the standard of negligence must be high or must constitute gross negligence. A mere lack of care, attention, or skill is not adequate to constitute criminal negligence in medical professionals. This was contested in another case, where the bench argued that the terms “gross negligence,” “competence,” and “indifference” were not specified under IPC Section 304A. These developments in medical negligence law culminated in the landmark case of Jacob Mathew v. State of Punjab, which affirmed the principles mentioned in the Suresh Gupta case. In the case of Jacob Mathew v. State of Punjab, the importance of protecting medical professionals who offer highly valued services to society was emphasized. This case contributed their opinions as follows:
- The Bolam test was upheld as a valid test for judging negligence cases in India.
- Professional negligence was distinguished from occupational negligence.
- The essential components of negligence were stated as death, breach of care, and resulting damage.
- A simple mistake or an erroneous decision made during care does not constitute negligence if the decision aligns with acceptable practices prescribed by a medical professional of ordinary prudence.
- The doctrine of res ipsa loquitur has limited applicability in cases of medical criminal negligence.
The court therein stated, “Indiscriminate prosecution of medical professionals for criminal negligence is counter-productive and does no service or good to society.”
New Criminal Law and Medical Negligence
The new criminal law gives the punishment for medical negligence under BNS Section 106, which is set to replace IPC Section 304A. BNS Section 106 mandates a fixed jail term of two years along with a fine for deaths caused by medical practitioners due to negligence. This contrasts with IPC Section 304A, which prescribes either imprisonment of up to two years or a fine, making imprisonment mandatory under the new law. This change, from “or” to “and,” has been met with considerable public scrutiny and almost unanimous opposition from the medical fraternity. Demands have been made to the central government to stop the implementation of these laws by Tamil Nadu, Karnataka and even Kerala. Moreover, the inclusion of the term “medical practitioner” in BNS, which was absent in the previous law, intensifies feelings of injustice among board-certified professionals, who feel they are unfairly targeted. Medical professionals and doctors have actively protested against the revised law, arguing that the language used implies an unjust incrimination of those in the profession.
The Indian Medical Association (IMA) has also taken a strong stance against this provision, sending a letter to the Prime Minister stating that without mens rea, or malicious intent, there are no grounds for criminal prosecution of medical practitioners. Their contention is that professional medical practice should be exempt from criminal prosecution to ensure that healthcare providers can perform their duties without fear of undue legal repercussions. In discussions with Home Minister Amit Shah, he emphasized, “Currently, if a death occurs due to a doctor’s negligence, it is treated almost like murder, equating it to criminal negligence. Therefore, I will propose an official amendment to exempt doctors from such criminal negligence charges.” He reiterated their commitment to protecting medical professionals, but this was never followed through.
The new law serves as a significant deterrent to many medical practitioners, as they fear the potential for criminal charges. This can severely impact doctors treating critical patients, who risk losing their licenses, facing imprisonment, and jeopardizing their careers and reputations. Such a climate of fear can undermine the confidence of medical professionals to perform high-risk procedures or prescribe necessary medications, actions that could save countless lives but might be misconstrued as negligence. A law of this nature has the potential to cause severe harm to the healthcare system and inadvertently impinge on the fundamental right to health, prescribed under Article 21. There is an alarming possibility of a doctor’s decision-making being influenced by the fear of imprisonment rather than the best interest of the patient.
The role of law in medicine must strike a delicate balance. It should regulate medical practice to prevent negligence or malpractice, which can be fatal. However, this intervention must not serve as an obstacle to the doctors’ ability to deliver effective care. Greater protection for medical professionals in India is the need of the hour.
Way forward
Critical reforms in medical law are essential, considering the judiciary’s limited understanding of medical intricacies. The medical profession demands expertise that legal professionals lack, necessitating professional input and collaboration at every step of the way in the legislative processes. Doctors cannot be expected to practice under laws that jeopardize their careers while upholding quality care standards. Clear definitions of negligence, standard of care, and gross negligence are imperative. Legal reform, with assistance from a diverse perspective from the medical fraternity, is imperative in ensuring a just and fair law that is advantageous for patients and professionals alike. Additionally, mandatory training on patient-professional relations is crucial to navigating sensitive information about a patient’s death or condition, reducing the likelihood of litigation stemming from misunderstandings. Empathetic and honest information delivery acts as a deterrent to these and saves from the patient to plaintiff pipeline. Proper documentation is the best bet for defending medical professionals against prosecution. The importance of documentation needs to be reiterated in every clinic, hospital, and medical facility where the prescriptions, insurance, medical history, risks are all recorded and kept as evidence. Strengthening these aspects will foster a legal environment that supports ethical practice and protects both healthcare providers and patients.
Conclusion
Law and medicine are intricately intertwined in our modern society and economy. The judiciary plays a crucial role in ensuring that medical practitioners have a supportive legal environment to give their expert opinion without fear, as stated by Justice Sanjeev’s recent remarks. It is vital to recognize that doctors, while highly skilled, are not infallible, and subjecting them to excessive scrutiny can undermine patient care. Unrealistic expectations of modern medicine can also pose risks to vulnerable patients. The recent rise in criminal proceedings against doctors necessitates careful scrutiny and thoughtful consideration. The controversy surrounding new criminal laws and their impact on the medical profession highlights the urgent need for collaboration between legal experts and medical luminaries. A balance needs to be struck—one that upholds accountability while safeguarding the ability of doctors to practice medicine effectively. By working together, both fields can ensure that legal frameworks support ethical medical practice, uphold standards of care, and ultimately serve the best interests of patients and society.
Shreya Susan Cherian, CHRIST (Deemed to be) University