The article focuses on the laws pertaining to the health services in India and discusses certain cases that put light on the various issues and challenges faced by the medical industry.

If a person analyses the history of laws relating to health services, he can understand that no other field has undergone sweeping changes as the health sector. There is a u-turn in the concept of contractual obligations between a medical professional and his patient. For example, Section-16 of the Indian Contract Act 1872, which had hitherto considered doctor-patient relations as ‘fiduciary relationship’; has been completely denied its dominance because of the judgment and order in VP Shantha v/s Indian Medical Association of India. It redefined the relationship between doctor-patient as a contractual obligation between two different distinct, equal parties.  It has completely revoked the fiduciary relationship between them i.e., the doctor having an undue influence over the thinking process of patient so far.

Secondly, the method of adjudication of disputes relating to consumer cases has been completely changed from judicial scrutiny to quasi-judicial, i.e., a decision by a judicial person with another layman sitting in the consumer fora. Therefore, strict adherence of proof is not required in the consumer forum. No more expenses need to be incurred for filing a `money suit’ in a non-judicial stamp paper before a civil court; a simple complaint letter from the patient is enough for the forum to take action against the service-provider. This is something a service-provider like a nursing home, hospital or medical professional did not expect. But they have to face the reality now.

How to Prevent Litigation

The first step is to follow the principles enunciated from Bolam v/s. Frien Hospital Management Case. The Privy Council of Great Britain, in this case, has formulated three tests to be followed by medical professionals/hospitals.

1. Competent Test: Whether the medical professional is competent to do that particular procedure taking into consideration his qualification, experience and the equipment available to him in a particular hospital.
2. Due Care Test: Whether the medical professional has taken due care in attending the patient in question.  In short, that medical professional may be an expert and might have done for example, thousands of open-heart operations; but has he applied due care while operating this particular patient.
3. Time and Place Test: Whether the procedure which was selected by the medical professional is in vogue in that particular place and in that relevant time. Law does not expect an expert to follow a procedure which is being followed in a different country or was followed ten years back. The procedure should be practiced in that locality in that particular time.

The first test can be answered by ensuring appointment of duly qualified medical professionals in their hospitals. Hospitals/medical professionals can prove the second test only if they maintain proper medical records which will reveal various medical procedures carried out  by experts in that field, according to medical opinion, based on diagnostic test results.

The other important factor to be considered is to obtain `informed consent’ from the patient. If such consent is obtained, patient cannot take a stand later that he was not aware of the type of treatment that was given to him by the doctor. This is called in legal jargon as “Doctrine of Estoppel”. The simple meaning is that one person, who takes a stand before a forum about a thing in a particular manner cannot take an entirely different stand in another place about the same matter. In a simpler sense, if a person claims in one petition before a court in New Delhi that he is a post-graduate, he cannot take another stand later that he is a school dropout before a court in Thiruvananthapuram. Legally, if he takes a stand, he is estopped from doing such a thing in a court of law or else, he may commit the offense of perjury which is a punishable offense.  Likewise, a patient who is well informed about the medical profession, the procedure, the various risks, its percentage of risk factors and the cost of health services, cannot take another stand before a court in a later date that he did not know the type of treatment, procedure or cost involved. That is why a proper written consent form should be obtained from the patient or his relatives. The consent form is not a piece of paper which can be obtained in a stereo-typed way from patients mechanically. It is rather a continuous process wherein the medical professional and the patient sit together with the doctor explaining all details of the treatment he intends to do for the patient, while the patient interacts with the doctor and gets proper clarifications for all his reservations and queries.

Medical Professionals & Criminal Negligence

In few instances, cases of criminal negligence were registered against the medical professions U/S 304 A, 326, 327 and 328 of Indian Penal Code in different places in India. But the Hon’ble Supreme Court has come to the help of medical professional in Jacob Mathew v/s. State of Punjab, by imposing a condition to the law enforcing authorities to obtain a medical opinion from another doctor of the same specialty and if that opinion is negative, they cannot proceed further in criminal case. If the second opinion states that there is a negligence, resulting in the patient’s death/injury, the case can proceed further.

Medical jurisprudence in respect of consumer litigation had a smooth sailing, till a slight set back to the medical professional and hospital managers when the Hon’ble Supreme Court of India pronounced a historical judgment in Nizam Institute of Medical Sciences v/s Prasanth S. Dhananka and others. In this case, a sum of rupees one crore was ordered to be paid to the patient by the management of Nizam Institute of Medical Sciences (NIMS), Hyderabad. The deficiency, as observed by the judges was that complete investigation prior to the actual operation had not been carried out. The attending doctors were seriously remiss in the conduct of the operation and it was on account of this negligence that paraplegias had set in.

The case relates to a young engineering student of 20 years, who was referred to NIMS with complaints of recurring fever. He was diagnosed as having a mass in the left hemithrax with posterior mediastinal erosion of the left 2nd, 3rd and 4th rib. As several attempts at Fine Needle aspiration Cytology ((FNAC) under ultrasound guidance did not give any conclusive evidence as to the nature of the mass detected in the x-ray examination, he was operated for tumour.  Immediately, after the surgery, the complainant developed acute paraplegia with a complete loss of control over both lower limbs. Detailed reasons of deficiency pointed out by the National Consumer Disputes Redressal Commission (NCDRC) are given below:

1. The hospital/medical professionals admitted to have known pre-operatively about the extension of tumour into intervertebral foramen. They should have resorted to the advice of a neurosurgery along with CT scan.
2. Not only did the medical professional failed to utilize the available pre-operative clinical information, he also failed to conduct necessary pre-operative diagnostic tests like MRI and myelogram, which would have provided the information pre-operatively on the extension of the mass into intervertebral foramen and which information would have brought a neurosurgeon from the start of treatment.
3. The complete case records were not submitted by the management to the NCDRC which gave negative inference of suppression of facts.
4. After the operation was over, the doctors never informed the anxious parents that the patient became paraplegic. They straight away left the operation theater and after a lapse of five hours, after much persuasion, the junior doctors revealed the the truth to the patient and his parents.
5. The hospital authorities failed to carryout their statutory function of exchanging opinion on the case with sister institutions in India and abroad for post-operative management to retrieve the patient from the damage to the extent possible.

Against the claim of Rs.4.61 crores, the NCDRC has ordered a total of Rs.15.5 lakhs.  Aggrieved by this order, the complainant himself filed an appeal and appeared before the Supreme Court and argued the case by himself  by sitting in the wheel chair. The Supreme Court has modified the NCDRC’s order and passed a judgment for an enhanced compensation to a tune of Rupees one crore  which is the highest compensation amount paid to a patient by a hospital in India, so far.

Safety Jacket for Medical Professional by Supreme Court

However, the medical fraternity can be safe and relieved because of the orders of the supreme court in Martin F. D’souza v/s. Mohd. Istfaq.   It is a boon to the medical, para-medical staff members and healthcare providers in India from unnecessary, capricious and vexatious litigations against medical fraternity by the patients and the law-enforcing authorities.

The salient features of the judgment are as follows:

Whenever a complaint is received against a doctor or hospital by the consumer fora (whether district, state or national) or by the criminal court, before issuing notice to the doctor or hospital, the concerned judicial authority should refer the matter to a competent doctor or committee of doctors for opinion.

• Only on receipt of an opinion that there is prima facie grounds for deficiency, notice can be issued to the concerned doctor/hospital.
• Police officials should not arrest or harass doctors unless the facts clearly come within the parameters given by the supreme court in Jacob Mathew’s case.
• If the police authorities arrest a doctor without following the above procedure, they have to face legal action.
• The courts and consumer fora are not experts in medical sciences and must not substitute their own views over that of specialists.

• New Relief in Other Areas
  
  Another notable development in labour jurisprudence applicable to hospitals has come through another judgment of the High Court of Delhi in Indraprastha Medical Corporation Ltd. v/s NCT of Delhi and others.

  Before the judgment was pronounced it was usual for all the dismissed employees who filed petitions before the labour court to take a plea with the concerned hospitals did not have a certified standing orders as provided in the industrial employment (standing orders) act 1946 because a single judge of Delhi High Court has held that the provision of the above said Act is applicable to hospitals.

  In all their petitions before labour courts in India filed by the dismissed employees shall hitherto attack the management that they did not have certified standing orders as provided in the Industrial Employment (Standing Orders) Act 1946 because a single judge of the Delhi High Court has held that the provision of the above said Act is applicable to hospitals.

  According to the provisions, every employer who employs more than one hundred employees, must have their own Standing Orders certified by the State Labour Commissioner.  For those employers who have less than one hundred employees,  the model Standing Orders in the said Act are to be followed. Because the Delhi High Court  has held that the provisions are applicable, the management of hospitals all over the country found it very difficult to convince the Labour court. To add to that, the above orders were not challenged upto the Supreme Court level to convince the Presiding Officers of the Labour Courts.  However, surprisingly a bench consisting of  Justice Markandey Khatju (as he the n was) and Justice Madan B. Lokur has held that the provision of the above said Act are not applicable to hospitals in the above case.

  The salient observations of the honourable judges are given below:

  1. The main activity of a hospital is to cure diseases and ailments and not to do washing, cleaning, generating power, cold storage, etc. The latter are only incidental activities. In other words, to determine whether an establishment is a factory or not under Section 2(m) of the Factories Act, we have to see the main activity which is being conducted in the establishment.
  2. By no stretch of imagination can it be said that the main work of a hospital is cleaning, washing, packing, oiling, generating power, etc. These are incidental activities to ensure proper cleanliness etc in a hospital.
  3. The decision of the Supreme Court interpreting the word `Industry’ in the Industrial Disputes Act, 1947 has no application in the Standing Orders Act.

  It is also a welcome sign that the High Courts of Kerala & Karnataka have subsequently given verdicts along similar lines.

  To sum up, the judicial pronouncements in the last five years have been positively helpful to the hospital industry as a whole. But it should be remembered that the same judiciary shall not spare a hospital where employees, by their utter negligence have caused irreparable loss to the individual, in that case courts shall go the extra mile to mitigate the suffering petitioner before it, rather than hospitals as an establishment as in the cases referred to above.

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