Medical Negligence Of Pathological Labs

The concept of negligence in the medical profession conceals its reliability. The services which are rendered by the medical professionals is the noblest. The rule of Vaidyo narayano harihi which means doctors are equal to Lord Vishnu has been embodied by the Aryans. There are certain profession which requires the exercise of some special skills such as that of doctors, lawyers, etc. When a man practices a profession it requires a particular level of learning. It impliedly means and assures the patient that he has the requisite knowledge, expertise and will exercise his skills with a reasonable degree of care and caution. It is the duty of the professional to take into consideration the “corpus of knowledge into his profession. For a long time, the medical profession has been highly respected but today due to the rapid increase in a number of litigation against a medical professional for their negligent conduct narrows down to the concept of medical negligence.[1]

Recently, a growing awareness has been made by the Indian Society regarding the rights of the patient. This trend is clearly visible as the number of cases against the medical professionals is rising day by day because of their negligent conduct claiming damages caused to them due to breach of confidentiality, medical negligence and also vitiated consent which arises out of the doctor-patient relationship. In the medical professional liability, the process of adjudication whether it is in a consumer court or regular civil or criminal court takes into consideration the common law principles with respect to negligence, vitiated consent and breach of confidentiality. But it should be kept in mind that the protection of patient’s rights should not be at the cost of professional integrity and autonomy. Therefore, a balance should be maintained between them and if no balance is maintained then the consequences of the same would be adverse.[2]

In India, medical negligence is a significant problem. As the standard of medical service and awareness among the population has increased, the dissatisfaction among patients is also bound to rise. This is because of increased commercialisation in the medical sector and a decline in the self-regulatory standard of the profession. The question relating to medical negligence arises only in a medical setting but the principles which determine its liability are legal. Therefore, it can be said that medical negligence is a combination of law and medicine. It is the point where purely medical judgment leaves off and legal standards begin to operate.[3]

Professional negligence, also known as medical negligence as the word suggests relates to the medical profession and is the consequence of some irregular conduct done by any member of a profession or while discharging some professional duties. But first of all, it is essential to know what does the term negligence means. The term “negligence” basically means that it is a breach of a legal duty that is to perform with care. Now the question is what is meant by legal duty. A legal duty to care in the medical profession means the duty which is given by law to every person to respect the legal rights of the other. Hence, the legal right of a person can be described as the provision provided by the law to protect the interest of its citizen.

In Blyth v. Birminghamm Waterworks Co.[4] Baron Alderson defines negligence as:

“Negligence is the 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.”

As per the maxim “ubi jus ibi remedium” whenever the legal right is breached there is a corresponding remedy associated with it.

According to Charlesworth & Percy[5] the term negligence has three meanings which are as follows:

  1. A state of mind, in which it is opposed to intention;
  2. Careless conduct; and
  3. The breach of duty to take care is imposed by either common or statute law.

Winfield defined negligence as:

“Negligence as a tort is the breach of a legal duty to take care which results in damages, undesired by the defendant.”[6]

From the above definitions, the three essential components of negligence that are recognised are resulting damage, duty and breach which basically means that:

  1. There must be a duty to take care of the part of the defendant towards the complainant;
  2. Breach of the said duty and
  3. Consequential damage that arises out of it.

There is no prescribed definition under the law that defines medical or professional negligence as a form of conduct that should be set apart from the conduct of any other member of society offering a service. In other words, it means that there is no distinction between the negligence of a doctor and that done by a plumber or window-cleaner.[7]

Medical treatment is usually considered risky and therefore, medical negligence is considered a complicated subject. There is always a risk associated with the medical treatment that something might go wrong. Along with this, there are different reactions of the human body of patients to the same treatment. In addition to this, there are many instances where the patients are harmed due to the inappropriate treatment given to them or there is a delay in giving such medications.

In Hunter v. Hanley[8], Lord President Clyde made the following observation and gave a precise definition of what is meant by the term medical negligence. According to him,

“The true test for establishing negligence in diagnosis or treatment on the part of the doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would have been guilty of, if acting with reasonable care”.

The following elements must be proved for medical negligence by the aggrieved party to the satisfaction of the court that:

  1. There is a duty to care on the part of the doctor and should perform it by keeping in mind the standard of professional conduct which is to be followed by him.
  2. There is a breach of conduct in the duty of the doctor.
  3. Damage is suffered by the patient.
  4. The conduct of the doctor results in the direct and proximate cause of damage.

Legal Framework in India

The legal framework of Indian law which deals with the medical profession and which provides remedies and precludes the healthcare professionals from committing any malpractice must be introduced. In India, an aggrieved patient can file a complaint and sue a healthcare professional in various laws such as:

  1. The Constitution of India, 1949

Under the Indian Constitution, an aggrieved patient can file a complaint under Part III of the Constitution that deals with Fundamental Rights or Part IV of the Constitution that talks about Directive Principles of State Policy. Under Part III of the Constitution, he/she can file a complaint under Article 21 or Article 32 whereas under Part IV they can file a complaint under Article 41,42 and 47.

  • The Indian Penal Code, 1860

Under the Indian Penal Code, 1860 the following Sections deals with medical negligence which are as follows:

Section 52, 80,81, 88,  90, 92, 304-A, 337 and 338

In addition to these laws, the Indian Medical Council Act, 1956, the Consumer Protection Act, 1986 and the Public Interest Litigation under Article 32 of the Indian Constitution deals with the standard of professional conduct which is to be followed by the healthcare professionals and the malpractices which are to be abolished.

Medicolegal liability in Pathology and cases

When a pathological lab is set up it has to undergo various formalities and registration process in consonance with the Clinical Establishment (Registration and Regulation) Act, 2010.

The objective of the Act[9] states that:

“This Act has been enacted by the Central Govt. to provide for registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities and services provided by them.”

The term clinical establishment is defined under Section 2 (c)[10] of the Act and includes:

  • a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or
  • a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not

In 2018, an amendment has been made to the Act which prescribes minimum standards that are only available to medical diagnostic labs. Rule 8A [11]of the Act states that:

“Every clinical establishment relating to diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Schedule.”

In other words, it means that a pathological lab has to maintain certain minimum standards that are specified in the Schedule. If they do not follow the same, then they can be held liable for medical negligence.

Cases where Pathological Labs are held liable for medical negligence

Smt. Krishna Majumdar v. Bhattacharjee Pathology Lab. [12]

In this case,  the patient was suffering from some gynaecological problems and the doctor prescribed him to for a certain test. On prescription of doctor-patient undergone for the test and the report of the above examination was given on 08.06.2006 which shows that there was endometrial carcinoma. On seeing the report, the doctor advised her to consult a surgeon and further opined that it would be better to go for a centre of higher standard.. After this patient followed the same and admitted into Mumbai Tata Memorial Centre. The hospital re-examined her and a new test was done. When the reports came it was seen that there was no such problem from which the patient is suffering.

So, the suit was filed for deficiency of services and compensation for the loss of organ, mental pain, agony, harassment and litigation cost in State Consumer Disputes Redressal Commission. The court held that “ the appeal is allowed and the complaint is allowed in part. The O.P.s is directed to pay Rs. One lac ( Rs.75,000 + Rs.25,000) within 45 days from this date failing which the amount will carry interest at the rate of 10% per annum till realization.

The factors which are taken into consideration by the court in case of medical negligence by the Pathological Labs are as follows:

  • Pathological Labs should exercise a reasonable degree of care and skill and perform their duties diligently.
  • There should not be any deficiency in service by the pathological labs.
  • The amount of harm that has been suffered by the patient.
  • The burden of proof is on the patient and he needs to prove that the pathological lab’s negligence proximately and foreseeably resulted in an injury that caused or was associated with psychological stress.

But these factors varies from case to case depending on the physical and mental harm suffered by the patient and the reasonable degree of care and skill exercised by the labs.


It is the duty of a doctor as well as pathological labs to perform their duty with due diligence. Medical reports play an important role in the treatment of the patient as they guide the doctor on which organs of the patient are affected and the reports of the patient also guide the doctor regarding the health condition of the patient. If any negligence takes place with these reports it will amount to a big problem for the patient as wrong treatment will be given to them.

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[1] Shounak Mitra, Supreme Court and Medical Negligence Necessary Protection, Feb. 22, 2008-

[2] SV Joga Rao, Medical Negligence Liability Under the Consumer Protection Act: A Review of Judicial Perspective, 2009, Volume: 25, Issue: 3, pp. 361-371

[3] Bakshi, P.M. Law and Medicine, (1987) 97.

[4] (1856)11 Ex 781

[5] Negligence, Tenth Edition

[6] Definition of Negligence given by Sir Henry Princy Winfield

[7] Carrier John & Kendall Ian, Medical Negligence Complaint & Compensation, 1990

[8] 1955 (1st Division, Court of Session, Scotland)

[9] Clinical Establishment (Registration and Regulation) Act, 2010

[10] Clinical Establishment (Registration and Regulation) Act, 2010

[11] Clinical Establishment (Registration and Regulation) Amendment Act, 2018

[12] Decided on 31st January 2012, State Consumer Dispute Redressal Commission

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