Can this happen to you?

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A 32-year-old, one-eyed gentleman comes to the retina out-patient department with sudden loss of vision in the seeing eye. Subsequently, he undergoes detachment surgery in that eye and regains 6/12 vision. After about 2 months, he again comes with sudden loss of vision in the seeing eye. Vision now is counting fingers at 3 metres. Examination looks normal, with retina attached. OCT of the eye appears normal. Neurology work-up, including MRI, comes up normal. The next day, he informs the doctor that he has been on the oral medication febuxostat for hyperuricemia (prescribed by a local doctor) for the past 5 days, after which he lost his vision. ChatGPT supplies him with the necessary evidence for his claims, including successful litigation cases in similar scenarios. He intends to sue the general practitioner who prescribed febuxostat, and is convinced that his loss of vision is due to the side effect of the drug. The drug was prescribed to him at 80 mg daily dose, instead of the recommended 40 mg dosage. He was never informed of the possible side effects of the drug, and hence feels medication was started without his consent. LEGAL SCENARIOS THAT NEED ANSWERS Is consent required from the patient before starting a drug with possible side effects? What is the legal standing for such a case in the consumer court? Consent is perhaps the only principle that runs through all aspects of health care provisions today. It also represents the legal and ethical expression of the basic right to have one’s autonomy and self-determination. If a medical practitioner attempts to treat a person without valid consent, then he will be liable under both tort and criminal law. Often medical practitioners ask for precise prescriptions for the situations when written consent is needed. It is interesting to note that what law demands is mere consent and not written consent and does not prescribe such requirement on a mandatory basis. In fact, the medical practice itself determines the need for written consent. There is no mandate that a doctor should always obtain written consent and failure of which would hold him liable. However, if there is written consent, the medical practitioner would have greater ease in proving consent in case of litigation. To standardize the practice, the Medical Council of India (MCI) has laid down guidelines that are issued as regulations in which consent is required to be taken in writing before performing an operation.[1] However, the nature of the information that a patient must have in order to give informed consent is a debatable question, as the American and English viewpoints differ to some extent. Informed consent from the American sense is often described from the viewpoint of a prudent patient, popularly known as the prudent patient test. In this approach, the highest respect for the patient’s right of self-determination about a particular therapy is recognized. This will lead to a so-called objective test of disclosure wherein the doctor will keep in mind the patient and disclose all such information which is required to be given. In contrast to this, the English approach is doctor centric, which is also popularly narrated as the prudent doctor test of disclosure. Here, the doctor is taken as a professional-man endowed with greater prudence to protect the right interest of the patient and bestowed with the final right to decide what information shall be divulged to the patient considering the circumstances and how much information is to be divulged.[1] In the Indian context, there is a traditional notion of paternalism prevalent among the members of the medical fraternity. It is a notion where the doctor takes-up the role of a parent of the patient and starts deciding on behalf of the patient himself. Unfortunately, the law does not accept this notion. The first priority of law is always the right of autonomy of the patient provided he is endowed with necessary capacity. Informed written consent while prescribing medications is an open-ended question. Informed written consent while undergoing surgical procedures is accepted practice while the former still remains in the gray zone. A randomized control trial on patient recall was conducted. Though an informed consent regarding possible side effects of the drug prednisolone was taken, the study subjects showed poor recall of side effects when questioned later.[2] It is not always not practical to obtain an informed written consent while prescribing regular medications, but it must always be kept in mind. Azathioprine, an immunosuppressant, has adverse side effects (including bone marrow suppression) which could be fatal to the patient. It is always advisable, in such a situation, to obtain a written, informed consent before starting such medications. Wrong dosage and related complications are always a case of medical negligence, if it can be proven in a court of law. CONCLUSION Informed consent is a must before starting any kind of treatment. It can be an implied or express consent. It can be an oral consent or written informed consent. Written informed consent is usually mandated only for surgical procedures. While using medications with fatal side effects, it is always advisable to obtain an informed written consent since it can be an added advantage to the doctor if at all a litigation arises. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

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