This article is written by Kashish Varshney, Barkatullah University, Bhopal, an intern under Legal Vidhiya.
ABSTRACT
Misdiagnosis is not only a medical mistake; it is a profoundly human tragedy. When things go wrong with a diagnosis, the ripples extend far beyond the clinical record: treatment is delayed, diseases get worse, lives are disrupted, and, in some instances, patients die without ever knowing what went wrong. In India, where healthcare provisions tend to be overwhelmed and legal recourse may be cumbersome and out of reach, the effect of diagnostic negligence is particularly harsh. This paper examines the legal fallout of misdiagnosis within the context of Indian law, analyzing how civil, criminal, and consumer protection regimes deal with such lapses. It follows the development of judicial philosophy regarding medical negligence, deconstructing such doctrines as duty of care, res ipsa loquitur, and the expectations of medical practitioners to exercise reasonable skill and caution. Landmark cases and real-world examples are employed to demonstrate how courts have struggled to find a balance between medical autonomy and patient rights. The paper similarly compares international legal standards, providing insight into how other jurisdictions hold healthcare providers to account. In the end, this research is not merely about law; it is about human beings. It demands greater protection, clearer responsibility, and a more humane approach to the law to ensure that no patient suffers quietly as a result of an avoidable diagnostic failure.
KEYWORDS
Misdiagnosis, medical negligence, duty of care, malpractice, medical ethics, India, global healthcare law
INTRODUCTION
In a medical malpractice case you see a lot of things, like a misdiagnosis, and what does that mean? For example, you may be having a stroke and the doctors don’t realize it, or you may have cancer and the doctor doesn’t do the test that they’re supposed to based on the signs and symptoms, and that cancer continues to spread for sometimes years. A case of misdiagnosis typically means that the doctor did not follow the standard of care, and as a result, something was missed; typically, this resulted in a catastrophic injury to the patient.
WHAT IS MISDIAGNOSIS?
Misdiagnosis is an incorrect diagnosis of a disease or an illness. Misdiagnosis is when a medical professional incorrectly diagnoses an illness or medical condition, leading to inaccurate treatment. Legally, it may constitute medical negligence if the error breaches the standard of care expected from a competent practitioner.
LEGAL FRAMEWORK IN INDIA
In India, if someone is misdiagnosed by a doctor, they aren’t left without options. The law allows them to seek justice in different ways: by filing a civil case for compensation, pursuing criminal charges, or turning to consumer courts to hold healthcare accountable for poor service. The most common route for legal redress is through the Consumer Protection Act, 2019, which recognizes patients as consumers and medical services as “services.” This allows patients to file complaints in consumer courts without the burden of proving criminal intent. In the pivotal case of Indian Medical Association v. V.P. Shantha[1], the Supreme Court affirmed that medical services are covered under consumer protection law, significantly broadening avenues for legal redress.
To charge ‘criminal negligence,’ the level of negligence needs to be of a high standard traditionally described as gross negligence. This traditionally started with the two important landmark judgments given by the Hon’ble Supreme Court of India. Criminal liability may arise under Sec 106 of the Bhartiya Nyaya Sanhita, 2023 (Section 304A of the old IPC), which penalizes causing death by negligence.[2] First of all, what is negligence? Negligence in layman’s language is when there’s a duty to perform something, but you fail to perform such duty with proper care and caution, so your act constitutes negligence. To illustrates this, let’s consider a well-known scenario. Suppose a doctor performs a surgery with full intention to help the patient and without any wrongful motive. However, due to a lack of proper care and caution during the procedure, the doctor accidentally leaves a surgical instrument, such as a pair of scissors, inside the patient’s stomach. If this leads to the patient’s death, then despite the doctor’s good intentions, the act would still be considered negligent. In law, negligence is not only about intent but also about failing to meet the required standard of care.
Civil suits for damages can also be filed under tort law, where the patient must prove that the doctor breached their duty of care and caused harm.
The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, also provide ethical guidelines for doctors, including the duty to maintain accurate records, obtain informed consent, and act in the patient’s best interest.
JUDICIAL DOCTRINES AND BURDEN OF PROOF
In misdiagnosis cases, proving negligence can be challenging. The patient must establish four elements: duty, breach, causation, and damages. Courts sometimes invoke the doctrine of res ipsa loquitur, “the thing speaks for itself,” to infer negligence from the nature of the incident. This shifts the burden of proof to the doctor. For example, if a patient undergoes surgery for one condition but suffers damage to an unrelated organ, the court may presume negligence unless the doctor can prove otherwise.
LANDMARK JUDGMENTS IN INDIA
Dr. Suresh Gupta v. Government of N.C.T. of Delhi and another[3]
In this case, Mr. X, a 38 years healthy male has been posted for elective surgery that is basically surgery for deviated nasal septum. He arrived at the hospital, gave his consent, and goes for surgery. During the surgery, the doctors began giving him anesthesia. However, they realized that the correct size of the cuffed endotracheal tube which is used to keep the airway open was not available. Even though they didn’t have the right equipment, they continued with the surgery using a tube that was uncuffed and of the wrong size. Unfortunately, during the procedure, the blood entered Mr. X’s windpipe through the improperly sealed tube. This blocked his airway, and he died on the operating table. The postmortem report confirmed that the cause of death was asphyxia due to blood blocking the respiratory passage, which happened because the wrong tube was used. In this case the family became very upset they pressed charge against the both the doctors. That is anesthetist and the sergeant. They were charged under the Section 306A of IPC,1860 by telling causing death by negligence. District court held both the doctors were criminally responsible for the death. Even the High Court of Delhi went ahead with District Court decision. But however, in the apex court the apex court differed saying that for this act of not choosing a right endotracheal tube by the doctor during the surgery may amount for civil case but it cannot be described to be so reckless or grossly negligent as to make him criminally liable. Supreme Court said, imposing criminal liability in hospitals and doctors for everything that goes wrong is completely not warranted or not right from the civilized society. The doctors and hospital would be more worried about their own safety than giving all best treatment to the patient who are seriously ill. Such a beautiful judgment given by the Supreme Court of India with regard to this case. In this landmark judgment, the Supreme Court released both doctors from criminal liability and introduced the idea of ‘gross negligence’ which means only very serious and careless mistakes should be treated as criminal. This decision helped protect doctors from unfair criminal charges while still holding them accountable through civil law.
Jacob Mathew v. State of Punjab and Anr.[4]
Another landmark decision was taken by the Supreme Court. In this case, Mr. X was suffering from an advanced stage of cancer. No hospitals wanted him to admit because of the very nature of advanced cancer illness. The family finally went to Christian Medical College (CMC), Ludhiana. Doctors at CMC Ludhiana made it clear to the family members that the disease was of such a nature and had attained such gravity that peace and solace could only be gotten at home. Mr. X’s son was a highly influential person; he pressured CMC Ludhiana to admit his father. Based upon the compassionate ground, they admitted the patient. On one fine day at 11:00 P.M., Mr. X developed respiratory difficulty; he started gasping. The nurse was informed, brought an oxygen cylinder, and connected it to the patient. Unfortunately, the oxygen cylinder was empty, and Mr. X died. An FIR was registered against Jacob Mathew and his team under section 306A of IPC, 1860. The Supreme Court has made it clear that doctors should not be held negligent for failing to use a specific medical device if that equipment wasn’t commonly available at the time of treatment. In other words, expecting doctors to use tools that weren’t standard or accessible during that period is unfair and legally unsound. The Court also cautioned against the indiscriminate prosecution of medical professionals, stating that such actions can be harmful and ultimately do more damage than good to society.
In a recent case, the Supreme Court awarded ₹10 lakhs in compensation to a patient who suffered hoarseness of voice due to medical negligence while receiving anesthesia at Manipal Hospital. The patient had initially been granted ₹5 lakhs by the District Consumer Forum, but the Supreme Court increased the amount and directed the hospital to pay ₹10 lakhs along with interest. This judgment reflects the Court’s willingness to hold healthcare institutions accountable while also ensuring that justice is proportionate and grounded in medical realities.
EMPIRICAL DATA AND GLOBAL COMPARISONS
According to a 2024 study published in the Indian Journal of Medical Ethics, India witnesses over 5.2 million medical malpractice cases annually, with misdiagnosis accounting for a significant portion.[5] Litigation has surged by 400%, and only 46% of healthcare providers comply with ethical guidelines. In the United States, diagnostic errors represent nearly 30% of all medical malpractice claims, and 5% of patients are misdiagnosed each year.[6] In the UK, misdiagnosis is one of the leading causes of malpractice litigation, especially in cancer and cardiovascular cases.
Globally, countries like South Africa, the UAE, and the UK have codified medical liability laws. In South Africa, Section 27 of the Constitution guarantees the right to healthcare[7], and courts have held doctors accountable under constitutional torts. In the UAE, Federal Law No. 4 of 2016 imposes fines and imprisonment for medical errors due to negligence.
NEWS REPORTS AND REAL-LIFE CASES
Recent news reports in India reveal the growing public awareness of medical negligence. In August 2025, City Care Hospital in Bhopal was sealed after failing to respond to notices regarding alleged negligence.[8] In Navi Mumbai, a patient permanently lost vision due to a botched eye surgery, and the court awarded Rs.7 lakh in compensation.[9] In Kanpur, a patient died after being left unattended for hours, raising serious questions about hospital accountability.[10]
These incidents reflect the urgent need for better regulation, transparency, and enforcement in the healthcare sector.
INTERNATIONAL NORMS AND UN RECOGNITION
The Universal Declaration of Human Rights (Article 25) and the International Covenant on Economic, Social and Cultural Rights (Article 12) recognizes the right to health. The UN Human Rights Council Resolution (2022) declared a clean, healthy, and sustainable environment as a human right, indirectly reinforcing the need for accurate medical diagnosis.
The World Health Organization has emphasized diagnostic accuracy as a key component of patient safety. The Global Patient Safety Action Plan 2021-2030 calls for systemic reforms to reduce diagnostic errors.
LEGAL CONSEQUENCES AND REMEDIES
The legal consequences of misdiagnosis range from civil liability to criminal prosecution. Patients may seek compensation for physical harm, emotional distress, and financial losses. Courts may award general damages (pain and suffering), special damages (medical expenses), and punitive damages in cases of gross negligence.
Doctors found guilty of misdiagnosis may face disciplinary action from medical councils, suspension of licenses, and reputational damage. Hospitals may be held vicariously liable for the actions of their staff.
CONCLUSION
To conclude, misdiagnosis is not just a medical mistake, it is a breach of trust and a violation of rights. In India, misdiagnosis can lead to legal action under civil law (for compensation), criminal law (for causing death by negligence), and Consumer law (for poor service). Mere lack of proper care, precaution and attention or inadvertence might create ‘civil liability’ but not a criminal one. To charge ‘criminal negligence’ the level of negligence needs to be of high a standard traditionally described as ‘gross negligence’. The law must continue to evolve not just to punish negligence, but to promote a culture of care, competence, and compassion.
REFRENCES
- The Bharatiya Nyaya Sanhita, 2023
- Overview of Diagnostic Error in Health Care https://www.ncbi.nlm.nih.gov/books/NBK338594/,
[1] Indian Medical Association v. V.P. Shantha & Ors., AIR 1996, SC 550
[2] Bharatiya Nyaya Sanhita,2023, Sec 106.
[3] Dr. Suresh Gupta v. Govt. of N.C.T. of Delhi & Anr., AIR 2004, SC 4091
[4] Jacob Mathew v. State of Punjab & Anr., AIR 2005 SC 3180.
[5] https://www.business-standard.com/finance/personal-finance/over-5-2-mn-medical-malpractice-cases-filed-in-india-annually-shows-data-124042900073_1.html, last visited Aug 14, 2025
[6] https://focusconlaw.com/the-consequences-of-medical-misdiagnosis/, last visited Aug 14, 2025
[7] South Africa Const. sec 27, 1996
[8] https://www.freepressjournal.in/bhopal/bhopals-city-care-hospital-sealed-over-alleged-medical-negligence, last visited Aug 14, 2025
[9] https://www.mid-day.com/mumbai/mumbai-news ,last visited Aug 14, 2025
[10] https://www.news18.com/india/patient-dies-due-to-negligence-at-up-hospital-decomposing-body-left-in-ward-after-death-ws-e-9499564.html, last visited Aug 14, 2025
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