What Does the Law Say on Medical Negligence and Issues of Diagnosis, Treatment, Informed Consent, Interference and Damages?
Everyone falls sick one time or other and needs to go to a doctor for medical attention. A misdiagnosis, an inaccurate treatment or a tragedy leads to disputes we classify in law as medical negligence. Patients worry if they are getting the best care while doctors worry about the legal implications. These worries are a result of lack of proper understanding of the law on medical negligence.
The law on medical negligence is affected by developments across the world. It creates a few dos and don’ts for the patients and doctors alike. With the help of significant court judgements from India and across the world, this article aims to acquaint the patients, doctors and medical practitioners with some basic guidelines to prevent litigation.
Diagnosis and Treatment
The law on the acceptability of diagnosis and treatment is well developed. In short, the doctors are required to be prudent when it comes to diagnosis and treatment. Practically, it means that a general body of experts should concur with the doctor’s action.
Doctors and hospitals are legally responsible for the standard of care. The standard of care has two parameters—first the standard should be acceptable to a general body of experts. The standard of care should also be up to date considering developments in the field of medicine. Thus, doctors and hospitals are required to keep abreast of new practices in medicine. Further, all the medical professionals involved in providing the treatment procedure are required to possess the necessary skills.
Second, the standard of care should also meet the common-sense test. Related examples of cases are blood transfusion of the wrong type, employing unqualified nurses, empty oxygen cylinders etc. From my personal experience, I could add some more—such as quack medical supervisors, over-worked resident doctors, improper medical records, hospitals and nursing homes not having appropriate permissions from the Medical Council of India and local authorities, open/exposed medical waste in patient area, etc.
As clarified in Balram Prasad case, the liability of the hospital is residuary and therefore in many cases maximum. The responsibility of the hospitals is two-fold. First is the substantive responsibility. The hospitals are required to ensure efficient and effective diagnosis and treatment. They need to ensure that the doctors are qualified, that they have tools and techniques available at their disposal for the best possible patient care. Second, the hospitals also have procedural responsibility. Any shortfall in either of these two duties creates a liability. The hospitals need to ensure that the standards on these two aspects meet the requirement.
Legally, the decision with respect to diagnosis rests exclusively with the doctor. Whether the diagnosis is correct can only be determined by a doctor or a body of expert doctors. But the decision with respect to treatment is taken jointly between the doctor, patient, patients’ family and other stake-holders. The interests of the patient are paramount in this decision. To arrive at both these decisions we need information.
The law expects the patients to supply the information about their conditions to the doctor. This information covers symptoms, allergies, etc. but also much more.
Court decisions indicate that a patient should also highlight her concerns and apprehensions that help her decide—i.e. her decision parameters. Thus, “incessant questioning” was held as an indicator of patient’s apprehension about possible complications arising from an operation. An explicit comment about not wanting to lose her voice was found to be a relevant concern raised by the patient. Thus, the law expects patients to be curious about the risks involved at all stages - diagnosis, treatment and possible side-effects or possible complications. The patients, therefore, should also seek information about the diagnosis, treatment and the risks involved in all the procedures.
Doctors must understand that informing the patient is absolutely critical. The information must be complete and easily understandable. In general, it is absolutely essential to discuss the possible outcomes, possible risks and potential complications arising from the procedure.
Various decisions indicate that the doctors must be vigilant about understanding the patients’ decision-making process as well. They must glean from patient interaction as to what sort of risks the patient is accepting and what risks the patient does not wish to take. Using this information, the doctors must determine the kinds of risks they should inform the patient about. If it is unclear, they must directly point out the risks and seek the patients’ consent. The information, in the words of Lady Hale is “enough information [is] given so that the doctor is not acting negligently and is giving due protection to the patient's right of autonomy.”
Even in the matter of getting information from the patient, substantial responsibility rests with hospitals and clinics who deal in out-patient care. Many hospitals have separate professionals, junior doctors usually, who get detailed information from the patients based on predesigned forms. While the intent is salutary, such over-reliance on forms is also not good. Hospitals must aim for materiality and relevance and allow for judicious departure from norms.
The question of informed consent in important in the Indian context. Firstly, Indian hospitals and doctors tend to get blanket consent that the common law jurisprudence rejects. Secondly, the concept of informed consent, while accepted in Indian jurisprudence, has not been rigorously tested.
We find that the Indian law does not approve of the term “informed consent” and favours “real consent”, a legacy of English law. However, both are practically the same. Thus, in the Samira Kohli case, the court, while using the term “real consent” has described various principles associated with it. The principles enlisted are quite illuminating and should be read entirely in the case description.
The courts states that the consent should be “prior consent” before undertaking the procedure. The consent should be obtained after providing “adequate information” but not overburden the patient with remote risks. The court has clarified it as “the doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment.” The court further states that the consent for diagnostic procedure cannot be extended to treatment and a separate consent is required for that. However, in certain cases consent for both may be taken together but the same must be clearly explained to the patient.
Many hospitals have specialists who inform the patients of the risks related to the diagnosis and treatment. The process is iterative, and more information must be sought and given to meet the high standard of consent required by law. The standard of consent globally established is quite high and Indian law is expected to progress rapidly towards that standard.
There are two additional complications when it comes to informed consent in India. First, in many cases you have patients who are illiterate and do not comprehend the kinds of risks they are undertaking. Second, Indian doctors are still seen in their paternalistic role when it comes to general patient. Thus, I venture, the patient has to demonstrate a clear preference for knowing all the risks before the onus can be shifted to the doctor. Further, the patient needs to actively protect herself from the judicial presumption that sees doctors in a paternalistic role. Nevertheless, I expect we shall soon see developments with respect to “informed consent” in Indian law.
The law recognises that there are cases of emergency where a doctor has to make a choice in the absence of information or consent. The law allows for the doctor to take any and all actions in the interest of the patient’s health and safety. There are two conditions: the doctor’s action should be in good faith and there has to be an emergency. In the Samira Kohli case, the Supreme Court established that the consent had not been proper though it concluded that the action of the doctor was in good faith and in the interest of the patient. There is another condition in which the doctor is allowed to withhold information – if she determines that it will affect the patient’s mental health.
Interference by Patient and Kin
Unfortunately, this aspect has no parallel in the international jurisprudence. While a paternalistic role is attributed to the doctors generally, it is not always the case. Therefore, Indian law also allows for defence of a non-cooperating patient and interference from the patients’ kin. In the Martin Dsouza case, the court concluded that the doctor was faced with a non-cooperative patient with multiple maladies and it therefore justified the deployment of extraordinary measures by the doctor.
However, the courts are careful in ascribing interference to the patient or patient’s kin and strong evidence is required for the same. Thus, in the Malaykumar Ganguly case, faced with the doctor’s incompetent handling of the patient, the patient’s husband (who was also a doctor) “interfered” with the treatment but it was held to be acceptable.
Patients and their kin should not interfere in the diagnosis and treatment. However, the patient and their kin are not restrained from making inquiries, making suggestions and indicating their views on the diagnosis or treatment.
Doctors should also note that what is “interference” is determined by a post-facto judicial scrutiny. Thus, if the patient is reasonable in her inquiry, suggestions or views on the diagnosis or treatment, then the burden on the doctors increases. The consequences of ignoring just and reasonable suggestions of the patients and their kin are quite drastic.
We can infer that consulting doctors need to keep a record of interference by the patient herself or by their kin, along with the case files and record the inquiries, suggestions and views in the said file along with the opinion of the relevant doctor. It is in the interest of the treating doctors and the hospitals that such instances be recorded and maintained properly.
Indian jurisprudence is compensatory and does not usually award exemplary damages. However, Indian jurisprudence is progressing rapidly in the case of award of damages. In this regard two landmark cases, Nizam Institute and Balram Prasad, have laid new ground rules. The Indian courts have transitioned from relying on multiplier method to more ad hoc damages that are closer to appropriate compensation for the loss suffered.
There are two areas where, in the future, there may be further enhancement. First, computation of legal costs. In Balram Prasad, we have seen some costs awarded for legal expenses. However, the determination of these costs is arbitrary and not in keeping with the actuals. This may change. Second, award of exemplary damages may be around the corner. The jurisprudence with respect to damages is affected from various quarters - motor vehicles, civil suits on contracts and those on other forms of negligence too. Since this particular element is a kind of tort law, as the tort law develops, we will see further development in the computation of damages.
Thus, as seen above, the law on medical negligence is keeping up with the changes in the society. These changes cast a duty on patients, doctors and hospitals to improve the standard of care in every aspect of medical practice. I believe the doctors and hospitals need to continuously review their procedures and ensure that the provided care meets the ever-stricter standards laid down by the courts.
(Rahul Prakash Deodhar, Advocate, Bombay High Court, has counselled Fortune 500 companies, public and private sector banks, hedge funds and private equity funds. He has previously worked with Aditya Birla Group, CRISIL and Morgan Stanley. He is the author of two books – Subverting Capitalism and Democracy and Understanding Firms. He can be reached at [email protected], on twitter at @rahuldeodhar or at his website www.rahuldeodhar.com.)