A tort is a residuary civil wrong. Duties in tort are fixed by the law and such duties are owed in rem or to the people at large generally.  Such wrongs can be remedied by filing for unliquidated damages. Negligence is a tort. A 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. In this article, we shall discuss medical negligence.

Medical Negligence basically is the misconduct by a medical practitioner or doctor by not providing enough care resulting in breach of their duties and harming the patients which are their consumers. Medical negligence occurs when a doctor, dentist, nurse, surgeon or any other medical professional performs their job in a way that deviates from this accepted medical standard of care. A medical professional is not liable in all cases where a patient has suffered an injury. He might have a valid defense that he has not breached the duty of care. 

Medical negligence has caused many deaths as well as adverse results to the patient’s health. Some examples of medical negligence are as follows: 

• improper administration of medicines.
• performing the wrong or inappropriate type of surgery.
• not giving proper medical advice.
• leaving any foreign object in the body of the patient such as a sponge or bandage, etc. after the surgery.

Mens Rea at Medical Negligence:

Negligence is a tort. The concept of mens rea is not applicable in torts. If doctor’s rash or negligent act endangers human life or personal safety of his patient, he can be tried for criminal liability. In Jacob Mathew case the Court held that in criminal law medical professionals are placed on a pedestal different from ordinary mortals. It was further held that to prosecute the medical professionals for negligence under criminal law, something more than mere negligence had to be proved. Medical professionals deal with patients and they are expected to make the best decisions in the circumstances of the case. Sometimes, the decision may not be correct, and that would not mean that the medical professional is guilty of criminal negligence. Such a medical professional may be liable to pay damages but unless negligence of a high order is shown the medical professionals should not be dragged into criminal proceedings.

In King v. Phillips, (1953) 1 QB 429 case, the Court observed that the question of negligence arises only when there is a direct harm to the plaintiff by the misconduct and the harm should be foreseeable. Damage is an important ingredient to bring negligence under tort.

In Calcutta Medical Research Institute vs Bimalesh Chatterjee December 09,1998 case, the Court held that the onus of proving proofs against negligence and deficiency in service was clearly on the complainant. 

In Sishir Rajan Saha v. The state of Tripura, AIR 2002 Guwahati 102 case, the Court held that if a doctor did not pay enough attention to the patients in government hospitals as a result of which the patient suffers, the doctor can be held liable to pay compensation to the patient.

In State of Haryana v. Smt Santra, 24 April, 2000 case, the Supreme Court held that it is the duty of every doctor to act with a reasonable degree of care. However, no human in this world is perfect and even specialists make mistakes, a doctor can be made liable only if he fails to act with such reasonable care that every doctor with ordinary skills would be able to do.

Types of Medical Negligence:

Misdiagnosis:

The first step in any medical treatment is diagnosis. When a medical professional fails to diagnose what condition a patient is suffering from, then it may result in misdiagnosis. if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.

In V. Kishan Rao Vs Nikhil Super Speciality Hospital, 8 March, 2010  case, where a lady who was to undergo the treatment for malaria fever was treated differently. An officer in the Malaria Department filed a suit against the hospital authorities for performing the treatment of his wife negligently, who was undergoing the treatment for typhoid fever instead of malaria fever. The husband got the compensation. In this case, the principle of res Ipsa loquitor was applied.

Delayed Diagnosis:

A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion.  A delay in diagnosis can lead to an undue injury to the patient if the illness or injury is allowed to progress rather than being treated. In these cases the doctor / hospital / clinic may even be held liable for any damages resulting from the delay in diagnosis and treatment.

Surgical Negligence:

Medical negligence during a surgical procedure can often result in further surgeries, infection and sepsis, internal organ damage, immune system failure and even death. surgery, unintentional lacerations of an internal organ, uncontrolled blood loss, perforation of an organ or a foreign object being left in the patient’s body.

Unnecessary Surgery:

Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks.  Sometimes surgery is chosen over more conventional treatments for their expediency and ease compared to other alternatives. Surgical negligence can also take place where an operation wasn’t necessary in the first place or the patient didn’t fully consent.

Errors in Anesthesia:

Anesthesia is a risky part of any major medical operation and requires a specialist (anesthetist) to administer and monitor its effect on the patient. Medical negligence can occur as a result of the improper application anesthesia or a failure to monitor how it is impacting the patient. The results can range from patients waking up during surgery to brain damage as a result of a lack of oxygen.

In Jagdish Ram v. State of H.P., AIR 2007 (NOC) 2498 (H.P.) case, the Court held that before performing any surgery the chart revealing information about the amount of anesthesia ad allergies of the patient should be mentioned so that an anesthetist can provide ample amount of medicines to the patient. The doctor in above case failed to do so as a result of the overdose of anesthesia the patient died and the doctor was held liable for the same.

Childbirth Trauma and Labour Malpractice:

There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labour, misdiagnosis of a new-born medical condition, etc. Birth injuries can include any harm the mother or baby suffers either during and after the pregnancy. These injuries can have life-changing ramifications for both mother and child.

In Jasbir Kaur v. State of Punjab, AIR 1995 P H 278 case, a newly born child was found missing from the bed in a hospital. The child was found bleeding and near the wash-basin of the bathroom. The hospital authorities argued that the child had been taken away by a cat which caused the damage to him. The court held that the hospital authorities were negligent and had not taken due care and precaution. The Court awarded the compensation.

Negligent Long-Term Treatment:

Most medical conditions are not cured overnight. Instead, it is likely that a patient will need long-term treatment or care. Where a medical professional fails to monitor the impact of the treatment properly or does not schedule the correct follow-up appointment, medical negligence can take place.

Prescription and Medication Errors:

These mistakes may take the form of the wrong medication or dosage being given to the patient, medications being prescribed together that should not be, or medications being given to patients despite knowing they are allergic to them. Taking the wrong medication, or an incorrect dose of medication, can have serious consequences including brain damage, allergic reaction, digestive problems, psychological illness and in some cases even death.

In Dr. Kunal Saha v. Dr. Sukumar Mukherjee, 21 October, 2011 case, which is famous as the Anuradha Saha Case. In this case, the wife was suffering from drug allergy and the doctors were negligent in prescribing appropriate medicines for the same which ultimately aggravated her condition and led to the death of the patient. The court held the doctor liable for medical negligence and awarded compensation.

In the case of C.P. Sreekumar (Dr.), MS (Ortho) v. S. Ramanujam, 1 May, 2009 case, the respondent was injured while going on a bicycle. He sustained severe injuries and a hairline fracture of the neck. On considering the various options available the doctor chose to perform hemiarthroplasty instead of internal fixation procedure. The surgery was performed the next day. The respondent filed a case against the doctor for not adopting the internal fixation procedure for the injury. The Supreme Court held that the appellant’s decision in choosing hemiarthroplasty with respect to a patient of 42 years of age was not so palpably erroneous or unacceptable as to dub it as a case of professional negligence.

Negligent Medical Advice:

Patient trusts medical professional’s expertise for treatment, Still doctor must advise on any risks, side effects or alternatives available. This advice is integral to being able to make an informed decision.

In Gian chand v. Vinod kumar Sharma, AIR 2008 H.P. 97 case, the Court held that shifting of the patient from one ward to another in spite of requirement of instant treatment to be given to the patient resulting in damage to the patient’s heath then the doctor or administrator of the hospital shall be held liable under negligence.

Civil Liabilities of Doctor in Medical Negligence:

Civil liability usually includes the claim for damages suffered in the form of compensation. If there is any breach of duty of care while operating or while the patient is under the supervision of the hospital or the medical professional they are held to be vicariously liable for such wrong committed. At times the senior doctors are even held vicariously liable for the wrongs committed by the junior doctors. Monetary compensation can be imposed under the general law by pursuing a remedy before appropriate Civil Court or Consumer forums.

In Mr. M Ramesh Reddy v. State of Andhra Pradesh, 2003 (1) CLD 81 (AP SCDRC) case the Court held the hospital authorities negligent, inter alia, for not keeping the bathroom clean, which resulted in the fall of an obstetrics patient in the bathroom leading to her death. A compensation of Rs. 1 Lac was awarded against the hospital.

Criminal Liabilities of Doctor in Medical Negligence:

There are various degrees of negligence and a very high degree of Gross Negligence is required to be proved beyond reasonable doubt for certain acts to be made punishable under the provisions of Criminal Law. As per existing Laws, cases for medical negligence caused by

Doctors can be filed under following enactments at the option of the Patients:

• A complaint for deficiency of service can be filed before the Consumer Forum under the Consumer Protection Act, 1986.
• A Civil Suit for the Recovery of Damages in the appropriate Civil Court.
• A complaint under Section 304–A of the Indian Penal Code, 1860 in the appropriate
• Criminal Court.
• A complaint to the Medical Council of India or The State Medical Council for de registration of a Doctor on account of negligence.

In Dr. Suresh Gupta vs Govt. Of N.C.T. Of Delhi, Appeal (crl.)  778 of 2004 case, the Supreme Court of India held that the legal position was quite clear and well settled that whenever a patient died due to medical negligence, the doctor was liable in civil law for paying the compensation. Only when the negligence was so gross and his act was as reckless as to endanger the life of the patient, criminal law for offence under section 304A of Indian Penal Code, 1860 will apply.

In Vinod Jain v. Santokba Durlabhji Memorial Hospital, 5 February, 2019 case, the Supreme Court has mentioned the factors to be considered while establishing the liability in medical negligence cases. The Supreme Court made the below-mentioned observations:

• A doctor cannot be said to be negligent if his acts are in accordance with the set guidelines, merely because a body is there which holds a contrary view.
• A doctor need not have special expertise in medicine and it is enough if he exercises ordinary skills that an ordinary man of that profession would be able to do.
• A doctor cannot give assurance for any recovery as it is not in his hands and he can only try his best. The only assurance he can give is that he holds requisite skills in the profession and while undertaking this he should perform his duties as a reasonable man of the profession and in accordance with the standard of care in the medical profession.  

Contributory Negligence:

A person is guilty of contributory negligence if he ought reasonably to have foreseen that if he did not act as a reasonable prudent man he might be hurt himself. In his reckonings he must take into account the possibility of others being careless. When plaintiff contributes to the incident his role should be duly regarded when liability is determined and quantum of damages is assessed. Contributory negligence is a good defence available to doctor in all claims of civil nature. Contributory negligence of a patient is any unreasonable conduct or absence of ordinary care on the part of the patient or his personal attendant which combined with the doctors’ negligence contributed to the injury complained of as a direct proximate cause and without which the injury would not have occurred

Contributory negligence include

• Failure to give the doctor accurate medical history
• Failure to cooperate with his doctor in carrying out all reasonable and proper instruction
• Refusal to take the suggested treatment
• Leaving the hospital against the doctors advise
• Failure to seek further medical assistance if symptoms persist

Doctrine of Res Ipsa Loquitur:

Res ipsa loquitur is a Latin maxim whose meaning is “the things tells its own story”. The doctrine of Res Ipsa Loquitur has three elements:

1. the injury that had occurred under the circumstances must be explicit and can only occur due to someone’s negligence and it cannot occur in the ordinary situations.
2. the injury caused by the defendant to the plaintiff must have been done with the use of some instrument which was exclusively under the control of the defendant.
3. the injury caused to the plaintiff must be under the scope of the defendant’s duty and it must not be due to the voluntary act or the contribution from the plaintiff’s side.

The first condition of doctrine is technical in nature and is difficult to prove plaintiff being the layman in respect to medical science cannot prove the medical negligence based on his/her common knowledge.

In Jaspal Singh v. Medical college case, the patient, blood group was A+ was give n B+ blood on two different fays, and he died soon thereafter.

Defences Available to Medical Practitioner:

• The Medical Practitioner has to prove that there is no existence of duty of care towards the patients.
• Medical Practitioner has to prove that he has conducted the treatment to his best effort with due care and the course of treatment which he chooses to perform is suitable in the situation of case and as per medical norms.
• Another defence which is available with the Medical Practitioner is to prove that the patient did not suffer any injury from the treatment performed by him.
• The doctor may claim that the injury was caused by the patient not following proper medical advice. (Contributory negligence).
• That the injury complained of was the result of an unavoidable risk connected to that particular line of treatment, which was fully explained to the patient and for which the patient’s informed consent was obtained.
• That the patient himself insisted on a particular line of treatment, despite having been told by the doctor about the risk and consequences attached to that line of treatment.

• Section 80 of the Indian Penal Code, 1860, says that anything which happens as a result of an accident or misfortune and without any criminal intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and caution is not an offense.
• Section 81 of the Indian Penal Code, 1860, states that if anything is done merely by the reason that it is likely to cause harm but if the same is done without any intention to cause harm and in good faith in order to avoid other damages to a person or his property is not an offense.
• Section 88 of the Indian Penal Code, 1860, says that no one can be made an accused of any offense if he performs an act in good faith for the good of other people and does not intend to cause harm even if there is a risk involved and the patient has given the consent explicitly or implicitly.

Precautions to be Taken by Medical Practitioner:

1. He must always respect the right of self-determination of the patient
2. He must treat the patient with due care and skill expected by the patient from a person trained in the medical profession.
3. He must adhere to standard and accepted practices of the medical profession when giving any treatment to the patient.
4. He must never give guarantee to the patient that the patient will be cured by him
5. After making full disclosure, all doctors must obtain an informed consent in writing from the patient, or his parent or guardian or near relative if patient is minor.
6. He must carefully record all the symptoms of the patient, the treatment given and progress made by the patient time to time and must kept record of this treatment.
7. He must consult a specialist wherever the need for such consultation arises.
8. He must not leave the patient unattended especially in the case of emergency.

Case Laws:

Dr. Jacob Mathew v. State of Punjab case:

A patient named Jiwan Lal was admitted to a private ward in CMC Hospital, Ludhiana. The patient suddenly had difficulty in breathing. His elder son called the nurse and doctor after seeing his father’s condition. No doctor turned up for about 20-25 minutes. After that, Dr. Jacob Mathew and Dr. Allen Joseph came to the room for the patient. The patient was immediately connected with an oxygen cylinder to his mouth which was empty. The son went to the adjoining room and brought another gas cylinder. During this, the doctor confirmed that the patient is dead. The younger son, Ashok Kumar Sharma filed a First Information Report (FIR) under Section 304A (causing death by negligence) read with Section 34 (common intention of criminal activity) of the IPC.

The Court observed that all the averments made in the complaint, even if held to be proved, do not make out a case of criminal rashness or negligence on the part of accused-appellant. There was no challenge to qualifications or method of treatment by the doctors. It is a cause of non-availability of oxygen cylinder for which hospital may be held liable in civil law but the accused-appellant cannot be proceeded against under Section 304-A of IPC on the parameters of Bolam’s test. Hence, the prosecution of the accused-appellant under Section 304A/34 is quashed. The Supreme Court prescribed following guidelines:

• A private complaint may not be entertained unless the complainant has produced prima facie evidence before the Court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor.
• The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam’s test to the facts collected in the investigation.
• A doctor accused of rashness or negligence, may not be arrested in a routine manner (simply because a charge has been leveled against him). Unless his arrest is necessary for furthering the investigation or for collecting evidence or unless the investigation officer feels satisfied that the doctor proceeded against would not make himself available to face the prosecution unless arrested, the arrest may be withheld.
• That is why in Jacob Mathew’s case the Court held that in case of criminal negligence against a medical professional it must be shown that the accused did something or failed to do something in the given facts and circumstances of the case which no medical professional in his ordinary senses and prudence would have done or failed to do.

In Poonam Verma v. Ashwin Patel 1996 (4) SCC case, Pramod Verma, husband of the appellant, Mrs. Poonam Verma fell ill and complained of fever and so, Ashwin Patel, who was an authorized Homeopathic kept him under mediation and gave him some allopathic medicines for viral fever for two days. But even after these medications the condition of Ashwin Patel didn’t improve so Ashwin Patel shifted the medications from viral fever to Typhoid Fever because according to Ashwin Patel these two diseases were prevalent in the locality. But even then the condition of Pramod Verma deteriorated and so Ashwin Patel asked the appellant to shift Pramod Verma to Sanjeevani Maternity and General Nursing Home under Dr. Rajeev Warty. Then Pramod Verma was shifted to Hinduja Hospital in an unconscious state where, after four and a half-hour of admission, he died. The Appellant therefore filed a petition before the National Consumer Disputes Redressal Commission, New Delhi. The issue was whether there was a breach of duty of care by Ashwin Patel in the treatment of Pramod Verma and whether this will amount to actionable negligence. The honourable Court found Ashwin Patel guilty for negligence and was made to pay compensation.

In Roe v. Minister of Health (1954 2 Q. B. 66), the case revolved around how anesthetic drugs are to be stored by a medical professional. The facts leading to the case occurred in 1947, when an anesthetist kept such drugs in a manner that was considered to be safe at that time. Seven years later, that in 1954, it was found that undetectable crack could develop in the ampules if stored in that manner, and therefore it was dangerous practice. Acquitting the anesthetist the Court commented that in 1947, the drug was kept in a manner considered safe at that time which was found to be unsafe later. Subsequent knowledge cannot be used to hold doctor negligent and commented “An incident of 1947 cannot be seen with spectacles of 1954”.

Conclusion:

Medical Negligence is the misconduct by a medical practitioner or doctor by not providing enough care resulting in breach of their duties and harming the patients which are their consumers. Any deviation from the accepted medical standard of care is considered to be medical negligence, and if it causes undue injury to a patient the doctor, staff and/or hospital may be held liable. Medical negligence becomes medical malpractice when the doctor’s negligent treatment causes injury to the patient—makes the patient’s condition worse, causes unreasonable and unexpected complications, or necessitates additional medical treatment. Medical negligence can occur in many different ways, the general theme is that a medical professional deviates from the level of care that is required by his or her duty to patients.

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Health is a vital indicator of human development and human development is the basic ingredient of economic and social development. According to the World Health Organization (WHO), health is a state of complete physical, mental and social well-being and not merely the absence of disease. The right to health for all people means that everyone should have access to the health services they need, when and where they need them, without suffering financial hardship. No one should get sick and die just because they are poor, or because they cannot access the health services they need. Good health is also clearly determined by other basic human rights including access to safe drinking water and sanitation, nutritious foods, adequate housing, education and safe working conditions. Everyone has the right to privacy and to be treated with respect and dignity. Nobody should be subjected to medical experimentation, forced medical examination, or given treatment without informed consent. The Indian Constitution has granted certain fundamental rights to its citizen under part III of it these rights play an important role with reference to the health and health care.

In CESC Ltd. v. Subash Chandra Bose, AIR 1992 SC 573 case, the Supreme Court relied on international instruments and concluded that right to health is a fundamental right. It went further and observed that health is not merely absence of sickness: “The term health implies more than an absence of sickness. Medical care and health facilities not only protect against sickness but also ensure stable manpower for economic development. Facilities of health and medical care generate devotion and dedication to give the workers’ best, physically as well as mentally, in productivity. It enables the worker to enjoy the fruit of his labour, to keep him physically fit and mentally alert for leading a successful economic, social and cultural life. The medical facilities are, therefore, part of social security and like gilt edged security, it would yield immediate return in the increased production or at any rate reduce absenteeism on grounds of sickness, etc. Health is thus a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”

Constitutional Provisions:

There is no direct mention of the “Right of Health” in the Constitution. But Article 21 refers to right to life which includes living with a good Health. In a leading case, the Supreme Court held that the right to life implies the right to live healthy life. The Constitution of India not only provides for the health care of the people but also directs the state to take necessary measures to improve the condition of health of the people. Though the provisions enshrined under this part have no direct link with the healthcare, however from various judicial interpretations it has been established that the intention of the legislature were there to cover the health as a right of the citizens.

Fundamental Rights:

Article 14:

Article 14 speaks about equality before law where the State shall not deny to any person equality before the law or the equal protection of the laws within the territory of India.

Article 15:

Article 15 contains provisions for a particular application of the general principle of ‘equality of treatment’ embodied in Article 14. It prohibits discrimination against citizens on the grounds only of religion, race, caste, sex, place of birth or any of them. Even nothing in this Article shall prevent the State from making any special provision for women and children for their betterment of life.

Article 19(1)(g):

According to Article 19 (1) (g) all citizens shall have the right to practice any profession, or carry on any occupation, trade or business subject to restrictions imposed in the interest of general public under clause (6) of Article 19. 

In Burrabazar Fire Works Dealers Association v. Commissioner of Police, Calcutta, AIR 1998 Cal 121 case, the Supreme Court held that Article 19 (1) (g) does not guarantee the freedom which takes away that community’s safety, health and peace.

Article 21:

According to Article 21 of the Constitution of India “no person shall be deprived of his/her life or personal liberty except according to the procedure established by law. Right to life under Article 21 of the Constitution has been generously deciphered to mean something more than only human presence and incorporates the right to live with nobility and conventionality. The use of word ‘Life’ in Article 21 of the Constitution has a lot more extensive importance which includes human nobility, the right to livelihood, right to health, right to pollution free air, and so forth.

In Bandhua Mukti Morcha v. Union of India, AIR 1984 SC 802 case, Bhagwati, J. observed: “This right to live with human dignity enshrined in Article 21 derives its life breath from the Directive Principles of State Policy and Particularly clauses (e) and (f) of Article 39 and Article 41 and 42.” Since the Directive Principles of State Policy are not enforceable in a Court of law, it may not be possible to compel the State through judicial process to make provision by statutory enactment or executive fiat for ensuring these basic essentials which go on to ensure a life of human dignity.

In Paschim Banga Khet Mazdoor Samity v. State of West Bengal, (1996) 4 SCC 37  case, while widening the scope of Article 21 and the government’s responsibility to provide medical aid to every person in the country, the Apex Court held that in a welfare state, the primary duty of the government is to secure the welfare of the people. Providing adequate medical facilities for the people is an obligation undertaken by the government in a welfare state. The government discharges this obligation by providing medical care to the persons seeking to avail of those facilities.

In Unnikrishnan, J.P. v. State of Andhra Pradesh, AIR 1993 SC 2178 case, the Court held that the maintenance and improvement of public health is the duty of the State to fulfill its constitutional obligations cast on it under Article 21 of the Constitution.

In the State of Punjab v. M.S. Chawla, AIR 1997 SC1225 case, the Court held that-the right to life ensured under Article 21 incorporates inside its ambit the right to health and clinical consideration. 

in Consumer Education and Research Center v. Union of India, AIR 1995 SC 922 case, the Supreme Court held that right to health, medical aid to protect the health and vigour of a worker while in service or postretirement is a fundamental right under Article 21. 

In Parmananda Katara Vs Union of India, AIR 1989 SC 2039 case, the apex court held that every doctor is bound to provide medical aid to the victims irrespective of the cause of injury; he cannot take any excuse of allowing law to take its course. Hence, if now a doctor refuses treatment, in case of emergency, he/she could be sued under the law. Once the doctor accepts the case and starts treatment, then the doctor-patient relationship is established. The Court further stated that preservation of health is of paramount importance. Once life is lost it cannot be restored. Hence, it is the duty of doctors to preserve life without any kind of discrimination.

Article 32:

Under Article 32 of the Constitution, any person whose fundamental rights are violated can approach the Supreme Court for restoration of his fundamental right. Similarly, under Article 226 of the Constitution, any person whose fundamental rights are violated can approach High Court of respective State for restoration of his fundamental right.

Directive Principles:

The Directive Principles of State Policy (DPSP), enshrined in Chapter IV of the Constitution of India, require the state to, among other duties.

Article 38:

Article 38 provides that, “the State shall strive to promote the welfare of the people by securing and protecting, as effectively as it may, a social order in which justice– — social, economic and political, shall inform all the institution of the national life”. Thus, a constitutional liability is imposed on state that the State will secure a social order for the promotion of welfare of the people including public health because without public health welfare of people is practically meaningless.

Article 39:

Article 39 enjoins upon the State that (i) that the health and strength of workers and the tender age of children are not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength and (ii) that children are given opportunities and facilities to develop in a healthy manner and in conditions of freedom and dignity and that childhood and youth are protected against exploitation and against moral and material abandonment.

In Lakshami Kant Pandey v. Union of India, 1987 AIR 232 case, Bhagawati, J. while delivering the opinion of the court observed that: “It is obvious that in civilized society the importance of child welfare cannot be overemphasized because the welfare of the entire community, its growth and development depends upon the health and well-being of its children. Children are a „supremely important national asset and the future well-being of the nation depends on how its children grow and develop.”

 In Sheela Barse v. Union of India, 1986 SCALE (2) 230 case, the Supreme Court held that “A child is a national asset and therefore, it is the duty of the State to look after the child with a view to ensuring full development of its Personality.”

Article 41:

Article 41 deals with right to work, education and public assistance in certain cases and thus imposed duty on the State to public assistance basically for those who are old, sick and disable. This Article specifically says that “the state shall within the limits of its economic capacity and development, make effective provisions for securing the right to work, to education and to public assistance in case of unemployment, old age, sickness and disablement, and in other cases of undeserved want”. Their implications in relation to health are obvious.

In Mahendra Pratap Singh v. State of Orissa, AIR 1997 Ori 37 case, the Court held that in a country like ours, it may not be possible to have sophisticated hospitals but definitely villagers within their limitations can aspire to have a Primary Health Centre. The government is required to assist people, get treatment and lead a healthy life. Thereby, there is an implication that the enforcing of the right to life is a duty of the state and that this duty covers the providing of right to primary health care.

Article 42:

Article 42 provides for just and humane conditions of work and maternity relief and gives the power to the State for making provisions in this regard, which implies that this Article is intended to protect the health of infants and mothers by providing maternity benefit.

In U.P.S.E. Board v. Harishankar, AIR 1980 SC 65 case, the Supreme Court held that Article 42 provides the basis of the larger body of labour law in India. Further referring to Article 42 and 43, the Supreme Court has emphasized that the Constitution expresses a deep concern for the welfare of the workers. The Court may not enforce the Directive Principles as such, but they must interpret law so as to further and not hinder the goal set out in the Directive Principles. 

In P Sivaswamy v. State of Andhra Pradesh, AIR 1988 SC 1863 case, the Supreme Court held that Article 42 of the Constitution makes it the obligation of the State to make provisions for securing just and humane conditions of work. There are several Articles in Part IV of the Constitution which indicate that it is the State’s obligation to create a social atmosphere befitting human dignity for citizens to live in.

Article 43:

Article 43 lays down that alia that the State must endeavour to secure a decent standard of life to all workers.

Article 45:

Article 45 lays down that the State must endeavour to provide any childhood care and education to all children under the age of six years.

Article 47:

Article 47 imposes duty on the State to raise the level of nutrition and the standard of living and to improve public health. It categorically provides that “the State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.”

In Vincent Panikurlangara v. Union of India, AIR 1987 SC 994 case, the Court stated that “maintenance and improvement of public health have to rank high as these are indispensable to the very physical existence of the community and on the betterment of these depends, the building of the society of which the Constitution makers envisaged. Attending to public health, in our opinion, therefore is of high priority perhaps the one at the top”. The Supreme Court while interpreting Article 47 has rightly stated that public health is to be protected for the betterment of the society. Further it has been held that, in this welfare era raising the level of nutrition and improvement in standard of living of the people are primary duties of the State.

Article 48A:

Article 48A ensures that State shall endeavour to protect and impose the pollution free environment for good health.

In M.C. Mehta v. Union of India, Writ Petition (civil) 13029 of 1985 Case, the Court held that, “Art 39 (a), 47 and 48-A by themselves and collectively cast a duty on the State to secure the health of the people, improve public health and protect and improve the environment”

In Virender Gaur v. State of Haryana, 1995 (2) SCC 577 case, the Supreme Court held that environmental, ecological, air and water pollution, etc., should be regarded as amounting to violation of right to health guaranteed by Article 21 of the Constitution.

Fundamental Duties:

Article 51A:

Article 51 A (g) under Part IV – A of the Constitution says that “it shall be the duties of every individual to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures.”

Euthanasia:

Euthanasia is described as the deliberate and intentional killing of a person for the benefit of that person in order to relieve him from pain and suffering. The term ‘Euthanasia’ is derived from the Greek words which literally means “good death” (Eu= Good; Thanatos=Death). Euthanasia is defined as the act of bringing the death of a person (patient) for the purpose of relieving the patient’s intolerable and incurable suffering. Typically, the physician’s motive is merciful and intended to end suffering. In voluntary euthanasia, a consent from the patient is taken. In non-voluntary euthanasia, the consent of patient is unavailable due to some reason.

In active euthanasia, the death of patient is brought directly by giving him a lethal dose of poisonous drug. In passive euthanasia, the life supporting system to the patient is discontinued and ultimately patient dies. In Aruna Shanbaug v. Union of India, the Supreme Court opposed active euthanasia but has given nod to passive euthanasia.

Conclusion:

From the above discussion, it is evident that right to life also includes right to health and therefore the state and its instruments, are duty bound to provide health care facilities and services to all its citizens without any discrimination. The Constitution also stipulates certain duties for the citizens towards contributing to the promotion of health in the country.

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A Medico-Legal Case (MLC) can be defined as a case of injury or ailment, etc., in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. It may be a legal case requiring medical expertise when brought by the police for examination. In this article we shall discuss medico-legal aspect of sexual assault.

List of Medico-Legal Cases:

• All cases of injuries and burns -the circumstances of which suggest commission of an offense by somebody. (Irrespective of suspicion of foul play)
• All vehicular, factory or other unnatural accident cases specially when there is a likelihood of patient’s death or grievous hurt.
• Cases of suspected or evident sexual assault.
• Cases of suspected or evident criminal abortion.
• Cases of unconsciousness where its cause is not natural or not clear.
• All cases of suspected or evident poisoning or intoxication.
• Cases referred from a court or otherwise for age estimation.
• Cases brought dead with improper history creating suspicion of an offense.
• Cases of suspected self-infliction of injuries or attempted suicide.
• Any other case not falling under the above categories but has legal implications

Medical professionals are often unsure of the course of action in medico-legal cases. Thus, they are rather reluctant to attend to cases of accident for fear of being involved in unnecessary litigation later on. Even in cases of serious accidents, medical professionals hesitate to offer help, sometimes resulting in patient’s death. The first question that arises in such cases is whether any medical man can be forced to accept an accident victim. The answer to this till some time back was very clear. The doctor could choose patients according to his own will.

In Parmananda Katara Vs Union of India, AIR 1989 SC 2039 case, the apex court held that every doctor is bound to provide medical aid to the victims irrespective of the cause of injury; he cannot take any excuse of allowing law to take its course. Hence, if now a doctor refuses treatment, in case of emergency, he/she could be sued under the law. Once the doctor accepts the case and starts treatment, then the doctor-patient relationship is established.

The doctor or hospital is required to examine a victim of rape if she reports to the hospital directly, and voluntarily, without a police requisition.

In State of Karnataka v. Manjanna, 2000 (3) SCR 1007 case, the Supreme Court recognized that the rape victim’s need for a medical examination constituted a “medicolegal emergency”. Second, it was also the right of the victim of rape to approach medical services first before legally registering a complaint in a police station. The hospital was obliged to examine her right away; they could always subsequently initiate a police complaint on the request of the victim. The judgment also recognizes the three ways by which a hospital may receive a victim of rape: voluntary reporting by the victim; reporting on requisition by the police, and reporting on requisition by the Court.

Medico-Legal Aspect of Sexual Assault:

Section 375 of the Indian Penal Code defines the term “Rape” as follows:

A man is said to commit “rape” who, except in the case hereinafter excepted, has sexual intercourse with a woman under circumstances falling under any of the six following descriptions:

(First) — Against her will.

(Secondly) —Without her consent.

(Thirdly) — With her consent, when her consent has been obtained by putting her or any person in whom she is interested in fear of death or of hurt.

(Fourthly) —With her consent, when the man knows that he is not her husband, and that her consent is given because she believes that he is another man to whom she is or believes herself to be law¬fully married.

(Fifthly) — With her consent, when, at the time of giving such consent, by reason of unsoundness of mind or intoxication or the administration by him personally or through another of any stupe¬fying or unwholesome substance, she is unable to understand the nature and consequences of that to which she gives consent.

(Sixthly) — With or without her consent, when she is under sixteen years of age.

Explanation: Penetration is sufficient to constitute the sexual intercourse necessary to the offence of rape.

Exception: Sexual intercourse by a man with his own wife, the wife not being under fifteen years of age, is not rape.

Object of Rape Evaluation Test:

Victims of alleged Sexual offences like rape may be brought for the medical examination by police, or by order of a court, or the victim may come on their own. In the event the victim comes directly, the police will be informed and necessary action will be taken to register a case. The objects of medical examination are as follows:

1. Medical assessment and treatment of injuries and assessment, treatment, and prevention of pregnancy and Sexually transmitted diseases (STDs)
2. Collection of forensic evidence;
3. Psychological evaluation;
4. Psychological support;
5. Prepare reports required under the law.

The principal features of the examination are:

1. Primary data;
2. Physical Examination and mental condition;
3. Signs of struggle on clothes and body;
4. Local examination of the genitals.

Medico Legal Aspect of Sexual Assault with Reference to Victim:

Section 53(5) of the CrPC talks about examination of a female victim, which should be done by or under the supervision of a female doctor.
Section 164(A) CrPC explains the legal requirements for medical examination of a victim of rape. One of the main elements of this is that the consent of the victim is mandatory and should be part of the report.

The Section provides for a medical examination of the victim of rape by a registered medical practitioner. It also provides that when no woman doctor is available, there is no bar against a male doctor carrying out the examination, if the victim consents. Though getting the examination done by a woman doctor is ideal, the law does not mandate it, keeping in mind that a medical examination should not be postponed because of an extreme situation such as the want of a female doctor.

The same section mandates that a medical examination must be carried out within 24 hours of the police receiving information, thus recognizing this as a medico legal emergency and putting a timeframe for the investigating officer.

The report shall state precisely the reasons for each conclusion arrived at. The exact time of commencement and completion of the examination shall also be noted in the report. The registered medical practitioner shall, without delay, forward the report to the investigating officer, who shall forward it to the Magistrate referred to in section 173 of Cr. P. C. as part of the documents referred to in clause (a) of sub-section (5) of that section.

Medico Legal Aspect of Sexual Assault with Reference to Accused:

Section 53A of the CrPC provides for a detailed medical examination of a person accused of an offence of rape or an attempt to commit rape. A detailed medical examination is to be carried out by a registered medical practitioner (only allopathic doctors registered under the MCI) employed in a hospital run by government or local authority – and in the absence of such a practitioner within the radius of 16 km from the place where the offence has been committed, by any registered medical practitioner acting on the request of a police officer not below the rank of a sub inspector.

The medical examination should be carried out without any delay and a “reasoned” report be prepared recording the name and address of the accused, the person by whom he was brought, the age of the accused, marks of injury if any, a description of materials collected from the accused for DNA profiling, other material particulars in reasonable detail, and the exact time of commencement and completion of examination. The report should be forwarded without any delay to the investigating officer who in turn shall forward it to the magistrate concerned.

The report shall state precisely the reasons for each conclusion arrived at. The exact time of commencement and completion of the examination shall also be noted in the report. The registered medical practitioner shall, without delay, forward the report to the investigating officer, who shall forward it to the Magistrate referred to in section 173 of Cr. P. C. as part of the documents referred to in clause (a) of sub-section (5) of that section.

Where the accused in a case of sexual offence in police custody is brought for medical examination, consent is not required. Samples may be collected and handed over to the police for forensic examination.

SAFE Kit:

The kit was developed in Chicago in the mid-1970s by Louis Vittulo, in order to provide a more uniform protocol for evidence collection after sexual assaults. For years, the standardized tool was referred to as a Vitullo kit. Today it is colloquially referred to as a rape test kit or a rape kit, which is used interchangeably to refer to the specific evidence that is obtained through the use of the rape kit. Other terms and abbreviations used are sexual assault kit (SAK), a sexual assault forensic evidence kit (SAFE), sexual assault evidence collection kit (SAECK) and PERK (Physical Examination Recovery Kit).

A SAFE kit consists of small boxes, swabs, microscope slides, sterile containers, and plastic bags for collecting and storing evidence such as clothing fibers, hairs, saliva, blood, semen or body fluid from lips, cheeks, thighs, and vagina.

The kit is useful for investigations conducted after an alleged sexual assault, and can be used in evidence to punish the assailant. It is equally useful to exonerate persons who have been falsely accused of sexual assault.

In Delhi Commission of Women v. Delhi Police, W.P. (CRL) 696/2008 case, the Court mandated certain changes in the police system, health services, child welfare committees, legal services and support services in order to give justice to victims of rape. The court pronounced that a SAFE Kit (Sexual Assault Forensic Evidence collection kit) be used by all medical personnel for gathering and preserving physical evidence following sexual assault. Court issued guidelines to police, medical examiners, courts, and prosecution. Click here for guidelines

Guidelines for attending alleged victim of sexual offence

1. The date and time of arrival of the victim must be mentioned, both in the case sheet and the MLC Register. The duplicate copy of case sheet and Medicolegal Report shall be preserved for future reference.
2. The date and time of examination will be mentioned in the case sheet.
3. Case sheet will be initiated, noting personal particulars of the victim, along with date and the time of reporting.
4. MLC will be initiated after filling the MLC Register available at examination facility.
5. The alleged victim will be admitted if the medical condition is serious.
6. The police will be informed telephonically followed by in writing after filling up the MLC Register.
7. The Senior Registrar / Station HQ will be informed.
8. At least two identification marks of the victim will be mentioned in the case sheet as well as in MLC register.
9. Report to the police will be given by name of the victim or as an unknown case (If name of the victim is not known). Care must be taken to preserve the confidentiality of the victim from others not related with the case.
10. Police will register a case under the relevant section of the IPC.
11. The police may take the victim and the accused for medical examination at a hospital which is authorized to carry out medicolegal work.
12. Neither the victim nor accused in cases of sexual offences should be permitted to wash or take a bath till the medical examination is completed.
13. The proforma for recording medical examination of alleged rape victim and the accused are enclosed as in prescribed format respectively.
14. Consent of the victim must be obtained before starting the examination. The steps of examination and their purpose should be explained to the victim in a language she understands. The examination is to be carried out in the presence of a female attendant.
15. All injuries present on the body will be recorded. Line diagrams depicting the front and back of the body may be used for a better description of location of the injuries.
16. If the clothes are the same as those worn during the occurrence of alleged sexual offence, they should be carefully examined for the presence of blood, seminal stains, mud etc.
17. If there are any marks of suspicious stains, the clothes should be preserved with a view to forwarding them to forensic laboratory in prescribed format.
18. If there are foreign hairs, fibres, debris under the nails etc, they must be carefully preserved and sent to experts of forensic laboratory for comparison with those found on the accused. Specimens should include vaginal swab, preferably from the posterior fornix.
19. Care must be taken to preserve various samples of medicolegal importance for their submission to respective police authority.
20. In case the victim reports herself directly to the hospital after the alleged crime, she should not be sent to the police station for legal formalities; instead the police will be called to the hospital for the necessary requirements.

Other Legal provisions Associated with Sexual Assault:

• U/s 228A of Indian Penal Code, no person can disclose the name of the rape victim and if anybody discloses the name, he shall be punished with either description for a term which may extend to two years and shall also be liable for fine.
• U/s 114-A of Indian Evidence Act, presumption can be made as to the absence of consent in certain prosecutions for rape. Whenever the person of a female victim is to be examined under section 53 [5] of Criminal Procedure Code (Cr. P. C), the examination shall be made only by, or under the supervision of, a female registered medical practitioner.
• U/s 327(2) of Code of Criminal Procedure, there should be in camera trial for all rape victims.

Conclusion:

Medico legal evidence has been considered an important component in the prosecution of crimes, especially those related to sexual violence. The courts heavily rely upon it. However, it is important to understand that forensic science itself is a new and emerging discipline. No forensic method has rigorously been able to demonstrate a definitive connection between a specific individual and a sample or source. So special precaution should be taken and care, emphasis should be laid on section 53 CrPC and 164A CrPC.

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Human experimentation can be broadly defined as anything done to an individual to learn how it will affect him. The main objective of human experimentation with drugs is the acquisition of new scientific knowledge rather than therapy. Human experimentation becomes most critical in the field of medicine, where the relationship between the experimenter and his subject is on a direct individual basis and the experiment may affect the subject’s health or life. Medical experimentation is therefore of vital interest to law and society. The traditional physician regarded his patient primarily as a subject for treatment rather than for experimentation. The traditional doctor-patient relationship gets affected by the pressures of experimentation so that now the physician is also an investigator, and the patient is also a subject.

Clinical Trials:

A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans. Clinical trial is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.

Requirements of Clinical Trials:

• Fully informed consent of all participants
• Full information to be given about the experiment, including its benefits and risks
• Attentions are to be drawn to possible alternatives
• If clinical trial involves a pregnant woman, extra care and protective measures must be taken

Need of Clinical Trials:

• For finding out bioequivalence data volunteer subjects, generally healthy individuals but occasionally in patients are used.
• For testing a drug usually Serum/plasma samples are obtained at regular intervals and assayed for parent drug concentration.
• But these alone neither feasible nor possible to compare the two products of various means of use for instance if drug is to be consumed by inhaling etc.
• Thus testing will be conducted to clinical trials at several different doses to derive expected results.

Phases of Clinical Trial:

There are 4 phases of biomedical clinical trials:

• Phase I studies usually test new drugs for the first time in a small group of people (20 – 80) to evaluate a safe dosage range and identify side effects.
• Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects (100 – 300) to monitor for any adverse effects.
• Phase III studies are conducted on larger populations (3000) and in different regions and countries, and are often the step right before a new treatment is approved.
• Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

Participating in Clinical Trials:

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:

• The reason for conducting the study
• Who may participate in the study (the eligibility criteria)
• The number of participants needed
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered about the participants

Concerns with Clinical Trials in India:

• The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects.
• Sometimes Clinical research organizations (CROs) recruit them selectively, exploiting financial need and medical ignorance.
• Because these subjects are well-paid, and get no therapeutic benefit, their only reward from the trial is financial.
• Such deception is a risk not only to volunteer health but also to society, because it can throw off the trial’s results.
• Due to this unethical practices unsafe drugs can make their way into the market and safe drugs can get rejected.
• Selectiveness in recruiting subjects for clinical trials leads to human rights violations and to bad science.

Functions of Ethics Committee in Clinical Trials:

According to the Drugs and Cosmetics rules, 1945. an Ethics Committee is a committee comprising of medical, scientific, non-medical and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.

If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.

Nuremberg Code:

A major issue at Nuremberg was defining the criteria for ethical human experimentation. Consequently, the Articles of the Nuremberg Tribunal developed as the first formal attempt to create a legal framework governing human experimentation. The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 Articles provide:

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on results of animal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Helsinki Declaration:

The concepts of Nuremberg were re-evaluated at the meeting of the World Medical Association in Helsinki in Finland, in June of 1964, and were incorporated into the Code of Ethics on Human Experimentation of the World Medical Association. Helsinki declaration of 1964 serves as Bible for all doctors doing biomedical research involving human participants. It is a set of ethical principles relating to human experimentation developed for the medical community by the World Medical Association in 1964, at Helsinki in Finland. It is very important and  best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. The current (2013) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes.

The fundamental principle underlying the declaration is respect for individual, his right to self-determination and his right to make an informed decision as regard s to his participation in research, both initially and during the course of research.

Medical research involving human subjects must conform to generally accepted scientific principles and must be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and animal experimentation. Medical research involving human subjects must be conducted only on individuals with appropriate ethics and scientific education, training and qualifications. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Based upon those underlying concepts the final Code (64th WMA General Assembly, Fortaleza, Brazil, October 2013) embodied the following basic principles:

Preamble

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

• The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”
• It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
• Medical progress is based on research that ultimately must include studies involving human subjects.
• The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
• Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
• While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
• It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
• Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
• Medical research should be conducted in a manner that minimises possible harm to the environment.
• Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
• Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
• Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
• Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

• In medical practice and in medical research, most interventions involve risks and burdens.
• Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
• All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
• Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

• Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.
• Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

• Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
• The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

• The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and Confidentiality

• Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

• Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
• In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.
• When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
• For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
• When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
• Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research  group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.
• The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
• For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

• The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances: Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

• In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

• Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
• Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

• In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

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A Medico-Legal Case (MLC) can be defined as a case of injury or ailment, etc., in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. It may be a legal case requiring medical expertise when brought by the police for examination. In this article we shall discuss medico-legal aspect of road accidents

List of Medico-Legal Cases:

• All cases of injuries and burns -the circumstances of which suggest commission of an offense by somebody. (Irrespective of suspicion of foul play)
• All vehicular, factory or other unnatural accident cases specially when there is a likelihood of patient’s death or grievous hurt.
• Cases of suspected or evident sexual assault.
• Cases of suspected or evident criminal abortion.
• Cases of unconsciousness where its cause is not natural or not clear.
• All cases of suspected or evident poisoning or intoxication.
• Cases referred from a court or otherwise for age estimation.
• Cases brought dead with improper history creating suspicion of an offense.
• Cases of suspected self-infliction of injuries or attempted suicide.
• Any other case not falling under the above categories but has legal implications

Medical professionals are often unsure of the course of action in medico-legal cases. Thus, they are rather reluctant to attend to cases of accident for fear of being involved in unnecessary litigation later on. Even in cases of serious accidents, medical professionals hesitate to offer help, sometimes resulting in patient’s death. The first question that arises in such cases is whether any medical man can be forced to accept an accident victim. The answer to this till some time back was very clear. The doctor could choose patients according to his own will.

In Parmananda Katara Vs Union of India, AIR 1989 SC 2039 case, the apex court held that every doctor is bound to provide medical aid to the victims irrespective of the cause of injury; he cannot take any excuse of allowing law to take its course. Hence, if now a doctor refuses treatment, in case of emergency, he/she could be sued under the law. Once the doctor accepts the case and starts treatment, then the doctor-patient relationship is established.

Medico-Legal Aspect of Road Accidents:

Immediate Treatment:

Some key factors that doctors need to keep in mind while receiving an road accident victim are:

• Inject TT Immediately: The doctor may forget to inject TT, and in such cases, if the patient develops tetanus, the doctors can face trial for negligence.
• Take X-rays: Taking X-rays of all possible parts to exclude fractures is crucial.
• Bleeding Points: Internal or external bleeding points should be examined, and should not be missed.
• Ophthalmoscopic Examination: Ophthalmoscopy is an examination of the back part of the eye (fundus), which includes the retina, optic disc, choroid, and blood vessels.

Procedure For Registering a Medico Legal Case:

1. Treatment: Treatment should start immediately. All legal formalities to be suspended till the patient is resuscitated.
2. Identification: When the patient is resuscitated , the medical practitioner must find whether the said case falls under Medico Legal Case or not.
3. Intimation to Police: if the case does fall in Medico Legal category, then he must register the case as an MLC and/ or intimate the same to the nearest police station, either by telephone or in writing.
4. Acknowledgement Receipt : He shall obtain from the police, the acknowledgement receipt for future reference.

Preparation for Medico Legal Case Report:

• The attending doctor should record all the findings and prepare a proper MLC report.
• He/she must record the preliminary particulars including full name, age, sex, occupation, date, and time, brought by whom and history of dying declaration whether necessary or not.
• Identification marks of the patient (details of minimum 2) should also be recorded.
• Date, time, finding, and description of injury (accurate measurements), whether the simple, grievous, or dangerous need to be recorded.
• The record of investigations performed on the patient like X-ray, USG, CT scan, and MRI must be maintained.
• Details of the injuries should be issued to the police or court on demand in the form of certificates. In the case of grievous injury, the details can be issued to the police even without a demand.
• The medical practitioner should fill a “wound certificate” and obtain a “written consent” from bystanders. The matter should be intimated to the police.
• Each page of the MLC report should bear the signature of the doctor and the patient, or a thumb impression of the latter. 
• The report must be written meticulously, expending thought on language and content. This report should demonstrate competence as MLC reports involve litigation, insurance claims, medical negligence claims, and worker compensation issues.

Investigation of Road Accident as MLC:

The Investigation of the accident must be done as soon as possible after it occurs because it helps in observing the conditions as they were at the time of the accident. Investigation officer may take help from an automobile expert and a medical expert. Establishment of facts includes visiting site of accident, examination of mechanical damages. If the driver of the vehicle is survived, his medical examination is mandatory. It should be ascertained if he was under the influence of alcohol or drugs at the time of accident. Medical examination of the victims must be conducted immediately. Medical examination includes noting of injuries suffered, place, angle, extent, and depth of injury. It also includes noting of blood stains on body, tears, grease marks, mud and soil stains, etc.

Generally, there are multiple causes. The investigation officer must consider all possibilities. He should also consider contributing factors which include environmental factors, design factors, human behaviour (carelessness, rushing, and fatigue, etc.). When determining negligence of one of the drivers, the contributory negligence of the other person has also to be taken into account.

In case of accidental death, an autopsy (post mortem) is often performed to ascertain the cause of death. An autopsy or post-mortem is a surgical procedure involving a thorough examination of the corpse by dissection to determine the cause and manner of death. The procedure is performed by specialist pathologists.

Punishment to Offender:

Where offence is committed, the offender must be punished. Rash and negligent driving, drunken driving, over-speeding, red light jumping, etc. are punishable offences. The punishment has dual purpose. It warns the offender that he should take care in future and it also deters other persons from rash and negligent driving.

Compensation to Victim:

Under the law, compensation is recoverable by the victim of the accident, and if he is dead, by his next-of-kin. It is mandatory for all vehicles to be properly insured at all the times.

According to Section 1A of the Fatal Accident Act, 1855 “Whenever the death of a person shall be caused by wrongful act, neglect or default, and the act, neglect or default is such as would (if death had not ensured) have entitled the party injured to maintain an action and recover damages in respect thereof, the party who would have been liable if death had not ensued shall be liable to an action or suit for damages, notwithstanding the death of the person injured, and although the death shall have been caused under such circumstances as amount in law to felony or other crime. Every such action or suit shall be for the benefit of the wife, husband, parent and child, if any, of the person whose death shall have been so caused, and shall be brought by and in the name of the executor, administrator or representative of the person deceased.

Concept of Golden Hour:

The ‘Golden Hour’ is the first hour after the Trauma. However, Golden hour is not always a predefined time period. Sometimes, according to the severity of the situation the golden hour can range from a few minutes to several hours. It is a concept that emphasises the urgency of care required by major trauma patients to prevent ‘early deaths’ predominantly from haemorrhage.

 R. Adams Cowley, founder of Shock Trauma Institute, Baltimore came up with the term ‘Golden Hour’ in the year 1975. He called this time as the time between life and death. According to him, if a person is critically injured, rather than dying right away, that person might have less than sixty minutes for any chance of survival. The concept of golden hour plays an important role even in the current situation as these spreads the importance of seeking urgent medical treatments in cases of traumas. The validity of this concept remains controversial

If proper and timely first aid is given, road accident victims have a higher chance of survival. Prompt action may also reduce the severity of the injuries. Many deaths and impact of injuries can be prevented with First Aid if causalities are treated immediately. One of the misconceptions about road accidents death is that most of them happen due to sever injury and loss of blood. But reality is that most common cause of death in road accidents due to loss of oxygen supply. Normally it takes less than four minutes for a blocked airway to cause death. It is said that these four minutes are crucial. It is not always possible that proper medical care reaches the victim within an hour. In that case the passer-by, onlookers and other people involved can provide the first aid to serious victims.

Good Samaritan Law:

According to the World Health Organisation (WHO), in the absence of established emergency medical services, bystanders can play a game changing role in saving lives. They can call for help, provide first-aid to the injured and even rush them to the nearest hospital, if an ambulance does not arrive in time.

A good Samaritan is a person who is good in faith, and without any expectation of any reward or payment, voluntarily comes forward to help and give immediate assistance and emergency care to a person injured in the accident or other mishap. Such person contacts the police and other authorities, provide first-aid to the injured person, and sometimes even take the person to a hospital if ambulance does not come in time.

In Save Life Foundation v. Union of India, AIR 2016 SC 1617 case, the Supreme Court gave following guidelines.

• A good Samaritan will not be liable for any civil or criminal action for any injury to the victim, or even his death.
• When such a person informs the police authorities or emergency services, he cannot be compelled to give his personal details.
• Such persons cannot also be forced to make the initial payments for the treatment of injured person.
• A good Samaritan cannot be compelled to appear as a witness in the court. But he may do it voluntarily.

Conclusion:

A Medico-Legal Case (MLC) is a case, in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. It is the legal duty of the treating doctor to report it to the nearest police station immediately after completing primary lifesaving medical care of the victim. Quick action by the police also helps to avoid the destruction of evidence by the treating physician.

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A traffic or road accident is defined as an accident involving at least one vehicle on a road open to public traffic in which at least one person is injured or killed. The main cause of accidents and crashes are due to human errors. Most of the road users are quite well aware of the general rules and safety measures while using roads but it is only the laxity on part of road users, which cause accidents and crashes. In this article, we shall study medico-legal aspect of road accident. In this article we shall discuss impact injuries and secondary injuries caused to pedestrian due to road accident.

The main causes for road accidents are:

1. Over-speeding and lane cutting
2. Distraction during driving
3. Drunken driving
4. Jumping red signal
5. Tailgating
6. Wrong lane driving
7. Potholes and damaged roads
8. Poor maintenance of vehicles
9. Large numbers and unruly pedestrians and animals
10. Poor lightings on roads

The road traffic injuries may be sustained to:

• Pedestrians
• Cyclists/ Motor cyclists
• Occupants of a vehicle

Pattern Injuries to Pedestrians:

In case of pedestrians following injuries are often seen:

Primary Impact Injuries:

These are the injuries caused by vehicle when it first struck and hit the person whether crossing the road from one side to the other side or walking with or against the traffic. The importance of primary impact injury is that the body of victim may bear design / pattern of the part of vehicle in form of imprint abrasion pattern bruised. Bumper, wing, headlights, mirrors, grill, headlights, radiator, door handles may cause primary impact injuries.

Projections of vehicle may cause specific injuries like fracture of tibia & fibula of one or both the legs. In case of children the fracture will be in femur. Height of the victim determines site of injury. The impact depends on the speed and weight of the vehicle.

The body part which bears the injury depends upon the position of the person such as:

1. Was the pedestrian struck by the front of Vehicle?
2. Was the pedestrian struck by the side of Vehicle?
3. Was the pedestrian standing on road?
4. Was the pedestrian walking on road?
5. Was the pedestrian lying on road?

The findings of primary impact injury are important to find out the relative position of pedestrian and vehicle and kind of vehicle involved in the Incident.

Impact Against Bumper (Bumper Injuries):

Injuries at the site of bumper impact, in the form of abrasion, contusion, laceration, internal hemorrhage in the calves etc. Most characteristic fracture due to bumper fractures are fracture of the tibia. The fracture fragments are wedge shaped and is displaced forwards. The base of the wedge indicates the site of the impact, the apex points in the direction in which the vehicle was travelling. Rarely, fibula also may get fractured. In children, bumper fracture is seen in femur.  When brakes are applied, the height of the bumper dips down, thus the height of the bumper fracture is less than the height of the bumper. When accelerator is pressed, the phenomenon is reversed.

The level of bumper injury (i.e, the height of injury from ground level) varies with height of bumper of different vehicle. The vehicle can be identified from the height of the bumper fracture from the ground and matching the same with the offending vehicle’s height of bumper from the ground. Frequently Bumper injuries are at different level of the two legs or absent on one leg, which suggest that the victim was walking or running when struck. If bumper injuries are at the same level on both legs, then it means the person is standing.

Impact against mud guard or head lamp:

At impact against the headlamp or mudguard may result in fracture of the pelvis or fracture dislocation of the sacroiliac joint. Injuries usually depend how the victim was positioned. Frontal impacts may cause head injury, chest injury, fracture of ribs. Side impact causes injuries of arms. Rear impact causes injuries to buttocks and sacroiliac joints. The fractured portion of the vertebral column may move forward and may cause transection of the spinal cord and thoracic aorta.

Impact when struck from front:

Injuries are virtually the same, except that the injuries are more on the frontal aspect. Intra-abdominal injuries are seen, like linear superficial tears of the abdomen and inguinal regions, due to over stretching of the skin. They appear dry, yellow and bloodless. Liver and splenic injuries are common. There may be injuries to chest wall and thoracic contents. Direct impact to thorax may cause rupture of the aorta below the arch at the level of ligamentum arteriosum due to sudden increase in the intravascular pressure. The heart may show bruising, laceration and rupture.

Impact when struck on one side:

The injuries are seen predominantly on one side. The opposite side receives injuries while falling on the road.

Impact when the pedestrian walks into the side of the moving vehicle:

There may be injuries on the side of the front of face, chest and arms in the form of glancing abrasions, patterned abrasions, crush lacerations, tear lacerations, fracture ribs with or without lung involvement, abdominal injuries etc.

Secondary Impact Injuries:

They are caused by the second impact with the vehicle (eg: the body of thrown onto the vehicle). They are caused when after sustaining primary impact of injury, the person may be lifted off the ground and thrown of the vehicle. Here the person strikes to windshield or bonnet or placed on the top of car/ vehicle. Usually, such injuries are on the opposite side of primary impact.

Injuries are variable, depending on the area of the body involved. If the feet slide forward, the whole body falls backwards, with a secondary impact of the head against the windshield. If the victim falls on the hood, tangential force is directed by hood to the buttock and thigh, causing separation of the skin and sub cutaneous tissues from the muscle. This produces a pocket in the upper thigh and buttock, leading to collection of large amounts of blood, which is often not visible, externally. If the feet are not firmly fixed on the ground, the victim may be scooped up and thrown in the air and may land over the roof of the vehicle, head hitting first, or may even land on the road behind the vehicle, where he may be run over by other vehicles. Atlanto-occipital dislocation and partial disruption of intervertebral discs are quite common in this situation.

Secondary and tertiary injuries:

They are caused when the body strikes the ground after the collision or striking another stationary object or another vehicle. When the victim is thrown high up in air and strikes the ground injuries are more severe. All kinds of injuries, including abrasions, contusions, lacerations, fractures etc may be seen.

Sometimes the victim may be run over by the same vehicle and another vehicle. Brain damage is frequent without any associated skull fractures. Fracture of the skull and ribs due direct contact with a surface, and fracture of spine due to hyperflexion or extension may be seen. In pedestrian accidents, the common cause of death is head injuries and fracture dislocation of cervical spine.

Run-Over Injuries:

They are caused when the vehicle runs over some part of the body of the victim. In this case the severity of injury depends on the part oof the body run over and the weight of the vehicle.

Abrasions in the form of grazes, impact or imprint abrasions of the tire marks may be seen. They are spread out a little due to yielding and flattening of body from pressure. Skull may be crushed from side to side or forced open with extrusion of the brain matter. The ribs may be fractured at multiple places. The abdomen may be ruptured with extrusion of the contents. The whole body maybe crushed or hemisected.

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Q81 Explain Appropriate Authority under the Transplantation of Human Organs Act.

The Central Government is empowered by the Act to appoint, by notification one or more officers as the Appropriate Authority for the purposes of the Act, for each of Union Territories. Likewise, every State must by notification, appoint one or more persons as the Appropriate Authority of that State.

Functions of Appropriate Authority:

Section 13 of the Act gives functions of the Appropriate Authority under the TOHO Act, 1994.

• to grant registration under sub-section (1) of section 15 or renew registration under sub-section (3) of that section;
• to suspend or cancel registration under sub-section (2) of section 16;
• to enforce such standards, as may be prescribed,— (A) for hospitals engaged in the removal, storage or transplantation of any human organ: (B) for Tissue Banks engaged in recovery, screening, testing, processing, storage and distribution of tissues;
• to investigate any complaint of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action;
• to inspect Tissue Banks periodically;
• to inspect hospitals periodically for examination of the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed; and
• to undertake such other measures as may be prescribed

Q82 Explain the Medico-legal aspects of road accidents.

A traffic or road accident is defined as an accident involving at least one vehicle on a road open to public traffic in which at least one person is injured or killed. The main cause of accidents and crashes are due to human errors. Most of the road users are quite well aware of the general rules and safety measures while using roads but it is only the laxity on part of road users, which cause accidents and crashes.

The Investigation of the accident must be done as soon as possible after it occurs because it helps in observing the conditions as they were at the time of the accident. Investigation officer may take help from an automobile expert and a medical expert. Establishment of facts includes visiting site of accident, examination of mechanical damages. If the driver of the vehicle is survived, his medical examination is mandatory. It should be ascertained if he was under the influence of alcohol or drugs at the time of accident. Medical examination of the victims must be conducted immediately. Medical examination includes noting of injuries suffered, place, angle, extent, and depth of injury. It also includes noting of blood stains on body, tears, grease marks, mud and soil stains, etc.

In case of accidental death, an autopsy (post mortem) is often performed to ascertain the cause of death. An autopsy or post-mortem is a surgical procedure involving a thorough examination of the corpse by dissection to determine the cause and manner of death. The procedure is performed by specialist pathologists.

Q83 What is medical negligence and explain contributory negligence?

A tort is a residuary civil wrong. Duties in tort are fixed by the law and such duties are owed in rem or to the people at large generally.  Such wrongs can be remedied by filing for unliquidated damages. Negligence is a tort. A 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.

Medical Negligence basically is the misconduct by a medical practitioner or doctor by not providing enough care resulting in breach of their duties and harming the patients which are their consumers. Medical negligence has caused many deaths as well as adverse results to the patient’s health. Some examples of medical negligence are as follows: 

• improper administration of medicines.
• performing the wrong or inappropriate type of surgery.
• not giving proper medical advice.
• leaving any foreign object in the body of the patient such as a sponge or bandage, etc. after the surgery.

A person is guilty of contributory negligence if he ought reasonably to have foreseen that if he did not act as a reasonable prudent man he might be hurt himself. In his reckonings he must take into account the possibility of others being careless. When plaintiff contributes to the incident his role should be duly regarded when liability is determined and quantum of damages is assessed. Contributory negligence is a good defence available to doctor in all claims of civil nature. Contributory negligence of a patient is any unreasonable conduct or absence of ordinary care on the part of the patient or his personal attendant which combined with the doctors’ negligence contributed to the injury complained of as a direct proximate cause and without which the injury would not have occurred

Contributory negligence include

• Failure to give the doctor accurate medical history
• Failure to cooperate with his doctor in carrying out all reasonable and proper instruction
• Refusal to take the suggested treatment
• Leaving the hospital against the doctors advise
• Failure to seek further medical assistance if symptoms persist

Q84 What are the rights of a registered medical practitioner?

Medical practitioner has following rights:

• Right to choose his patients
• Right to use his titles and qualifications
• Right to receive and recover fees and expenses
• Right to get appointed in Hospitals and Institution
• Right practice medicine and dispense medicine
• Right to issue medical certificates
• Right to Give Evidence
• Right to remove organs and tissues from a dead body
• Right to perform medical termination of pregnancy
• Right to disclose confidential information in exceptional circumstances
• Right to disclose and report injuries
• Right to access information
• Right not to be unfairly discriminated
• Right to have political views
• Right to refuse to conduct an unlawful bodily search or seizure

Q85. Write a short note on Homeopathy.

The systematic foundation of Homeopathic techniques was made by German physician Dr, Samuel Hahnemann. The word homeopathy is derived from two greek words, ‘homois’ means similar and ‘pathos’ means sufferings. Homeopathy is based on following three principles:

• The Law of Similars: Main principle is Similia Similibus Curantur meaning likes are cure by likes or likes be treated by likes.
• The Law of Minimum Dosage: In Homeopathy patient is given minimum dose so that toxic effect of dose can be eliminated. The dose is to stimulate internal immune system.
• The Law of Single Remedy: Homeopathy will try to treat patient by using single remedy, which is the most similar to the symptoms shown by the patient.

Homeopathy adopts holistic approach towards the patient. Hence Homeopathy may give two different medicines to two different patients suffering from the same problem. Homeopathy uses animal, plant, mineral and synthetic substances in the preparation of medicines.

Q86. Explain privileged communication and confidentiality in a doctor-patient relationship with case study.

If patient want to get a good treatment from a doctor he is expected to disclose all the details of his illness. Such information may be private and of personal nature and patient may like to disclose it to doctor only and not to others even not to relatives or friends. Now there is obligation on doctor not to disclose such information without obtaining prior permission from the patient. This expectation in medical field is called confidentiality in medical practice. If doctor fails to comply, the patient may ask for compensation on plea of breach of confidentiality. If assurance of confidentiality was not available, a patient hesitates to confide in his doctor, who in turn would not be able to give the best diagnosis or treatment.

A privileged communication is a conversation between two parties that is legally classified as a private discussion. This discussion is legally protected, and so cannot be disclosed to third parties. Sections 122 to 129 of the Indian Evidence Act, 1872 contain provisions related to privileged communication.

Sometimes public interest overrides the concept of confidentiality. If a patient is suffering from contagious disease and it is harmful to society as a whole. In such case the doctor has a duty to inform about the disease to health authorities in public interest.

In Mr. X v. Hospital Z, AIR 1999 SC 495 case, the apex court when commenting on infectious diseases held that in special circumstances, public interest would override the duty of confidentiality, as where there is an immediate or future health risk to the community or to a specific person

Q87. Discuss the medico-legal aspects of sexual assaults.

Section 375 of IPC defines the term “Rape”.

A man is said to commit “rape” who, except in the case hereinafter excepted, has sexual intercourse with a woman under circumstances falling under any of the six following de­scriptions:—

(First) — Against her will.

(Secondly) —Without her consent.

(Thirdly) — With her consent, when her consent has been obtained by putting her or any person in whom she is interested in fear of death or of hurt.

(Fourthly) —With her consent, when the man knows that he is not her husband, and that her consent is given because she believes that he is another man to whom she is or believes herself to be law­fully married.

(Fifthly) — With her consent, when, at the time of giving such consent, by reason of unsoundness of mind or intoxication or the administration by him personally or through another of any stupe­fying or unwholesome substance, she is unable to understand the nature and consequences of that to which she gives consent.

(Sixthly) — With or without her consent, when she is under sixteen years of age.

Explanation: Penetration is sufficient to constitute the sexual intercourse necessary to the offence of rape.

Exception: Sexual intercourse by a man with his own wife, the wife not being under fifteen years of age, is not rape.

Section 53(5) of the CrPC talks about examination of a female victim, which should be done by or under the supervision of a female doctor. Section 53A of the CrPC provides for a detailed medical examination of a person accused of an offence of rape or an attempt to commit rape.

A detailed medical examination is to be carried out by a registered medical practitioner employed in a hospital run by government or local authority without delay. A “reasoned” report be prepared recording the name and address of the accused, the person by whom he was brought, the age of the accused, marks of injury if any, a description of materials collected from the accused for DNA profiling, etc.

Section 164(A) CrPC explains the legal requirements for medical examination of a victim of rape. One of the main elements of this is that the consent of the victim is mandatory and should be part of the report. It provides for a medical examination of the victim of rape by a registered medical practitioner preferably woman within 24 hours of incidence of assault.

Q88. Explain the Nuremberg Code.

The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are: 

1. Voluntary consent is essential
2. The results of any experiment must be for the greater good of society
3. Human experiments should be based on previous animal experimentation
4. Experiments should be conducted by avoiding physical/mental suffering and injury
5. No experiments should be conducted if it is believed to cause death/disability
6. The risks should never exceed the benefits
7. Adequate facilities should be used to protect subjects
8. Experiments should be conducted only by qualified scientist
9. Subjects should be able to end their participation at any time
10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur

Q89. Explain Doctor-patient contractual relationship.

Following are the essentials of any contract:

• Proposal and Acceptance: Patient goes to doctor, seeking treatment for illness (Proposal). Doctor gives him an appointment and accepts him as a patient (Acceptance)
• Competencies of the Parties: According to the Contract Act, contracting parties should be major, and of sound mind. If patient is minor, the doctor is entering in contract with parents or guardians of minor.
• Free Consent: Here parties agree on the same thing in the same sense and the consent is not caused by coercion or undue influence or fraud or misrepresentation or mistake.
• Lawful Consideration and Object: In Doctor-Patient contract both the consideration and object are lawful. There is no unlawful in the treatment of a patient.
• The agreement should not be expressly prohibited by Ss. 27 to 30 of the Indian Contract Act: The Contract between patient and Doctor is not prohibited by these provisions.

Thus, all the requirements of valid contract are satisfied. This explains Doctor-Patient Contractual Relationship.

Q90. “At a private nursing home in Beed run by a well-known gynaecologist, some patients are discreetly informed about the gender of the foetus by use of colour code on payment of heavy fees. Briefly highlight the relevant legal pro visions applicable.

According to Section 2 (o) of the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, “sex selection” includes any procedure, technique, test or administration or prescription or provision of anything for the purpose of ensuring or increasing the probability that an embryo will be of a particular sex. Under Section 6 of the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, any test and technique to determine the sex of foetus is illegal.

According to Section 6 of the Act,

(a) no Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall conduct or cause to be conducted in its Centre, Laboratory or Clinic, pre-natal diagnostic techniques including ultrasonography, for the purpose of determining the sex of a foetus;

(b) no person shall conduct or cause to be conducted any pre-natal diagnostic techniques including ultrasonography for the purpose of determining the sex of a foetus;

(c) no person shall, by whatever means, cause or allow to be caused selection of sex before or after conception.

Q91. “Disha, aged 35, suddenly falls unconscious on a staircase of her building. Her neighbours immediately rush her to a hospital, where at the time of admission she is still unconscious. Explain the concept of Informed Consent and Implied Consent. Which of these will be applicable in the instant case? Explain with reasons.

Doctor-patient relation has all the requisites of a valid contract. Hence Doctor-Patient relation is a Contractual Relationship. According to Section 13 of the Indian Contract Act, ” two or more persons are said to be in consent when they agree upon the same thing in the same sense (Consensus-ad-idem). The consent may be expressed or implied. Implied consent occurs through the actions or conduct of the patient rather than direct communication through words. For example, informed consent can be implied from patient’s nodding of the head, or by them showing up at the agreed upon time for surgery. Informed consent is defined as voluntary acceptance by a competent patient of a plan for medical care after physician adequately discloses the proposed plan, its risks and benefits, and alternative approaches.

Disha at the time of admission to hospital is unconscious. She herself cannot give informed consent. In emergencies, when a decision must be made urgently, the patient is not able to participate in decision making, and the patient’s next keen is not available, physicians may initiate treatment without prior informed consent. In such situations, the physician should inform the patient/the next keen at the earliest opportunity and obtain consent for ongoing treatment in keeping with these guidelines.

Q92. What is meant by Hospital under the Transplantation of Human Organs Act,1994?

According to Section 2(g) of the Transplantation of Human Organs and Tissues Act, 1994, “hospital” includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution.

Q93. “What is a clinical trial?

A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.

Requirements of clinical trials are

• Fully informed consent of all participants
• Full information to be given about the experiment, including its benefits and risks
• Attentions are to be drawn to possible alternatives
• If clinical trial involves a pregnant woman, extra care and protective measures must be taken

Clinical trial is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.

Q94. What is meant by Female Foeticide?

Female foeticide is the procedure of abortion to terminate a female foetus from the womb of the mother before taking birth after the sex recognition tests like an ultrasound scan. The census figures not only indicate the imbalance in the sex ratio, but it also indicates, the casual approach of society to all women. It is the cruellest on the part of society not to allow a female child to be born.

Major Reasons for Female Foeticide:

• Patrilineal line of succession
• Dowry system, violence against women
• Low status of women
• Preference for son due to financial security
• Small family norm
• Religious and social taboos
• Misuse of diagnostic techniques.

Impact of Female Foeticide:

• The sex ratio denotes the ratio of females to males in a specific region. As per the decennial Indian census, the Sex Ratio of India is 107.48. It means 107.48 males per 100 females in 2019.
• It increases number of crimes against women

Q95. What is meant by Magic Remedy under the Drugs and Magic Remedies (Objectionable Advertisements) Act,1954?

According to Section 2(c) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, magic remedy‟ includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals.

Q96. Sumandevi, aged 85 who is bedridden for over 2 years at her home, is taken to a hospital. On admission, the doctor informs her family that she is brain-stem dead. Explain the concept of Brain Stem Death.

Brain stem is the “stalk of the brain” which connects the spinal cord to various parts of the brain. It sends messages to the rest of your body to regulate balance, breathing, heart rate and more. It is very vital part of the body. Section 2(d) of the Transplantation of Human Organs and Tissues Act, 1994, defines brainstem death as ““brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3 of the Act.”

Identification of brain stem death carries important prognosis for the survival of the patient, because the heart may keep on beating for few days after brain stem death, or even for weeks if the patient is in the Intensive Care Unit of hospital with all forms of medical and cardiac support. The person cannot perform fundamental work of an organism. The person is practically dead but may have heart beat and such person may still able to breathe. Such brain stem death must be certified by a Board of Medical Expert referred to in Section 3(6) of the Act. The Board should contain

• the registered medical practitioner in charge of the hospital in which brain-stem death has occurred;
• an independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority;
• a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority: Provided that where a neurologist or a neurosurgeon is not available, the registered medical practitioner may nominate an independent registered medical practitioner, being a surgeon or a physician and an anaesthetist or intensivist subject to the condition that they are not members of the transplantation team for the concerned recipient and to such conditions as may be prescribed;
• the registered medical practitioner treating the person whose brain-stem death has occurred.

Q97. What is Self-Regulation through Code of Conduct?

Self-regulation through a code of conduct in medical field refers to a doctor regulating his behaviour as a medical practitioner by complying with a code of conduct laid down by a recognized medical association or a peer group of doctors. After completion of medical studies, doctors take Hippocratic oath saying that they would serve society and observe ethical principles. During making decision in case involving medical negligence, correct line of treatment, the court can refer to the recommendation made by recognized bodies of doctors.

Students of medicine must be exposed to the professional ethics at the time of their regular education only. Even after graduation they should be trained through refresher course and seminars to keep them up to date on latest developments.

 Q98. “Pushpa has undergone a surgery and is subsequently discharged from hospital. Thereafter, as she complains of excruciating pain, she is readmitted to the hospital. A surgical instrument is discovered at the operation site. Briefly state the relevant legal provisions and enumerate the legal recourses applicable to Pushpa.

Medical Negligence basically is the misconduct by a medical practitioner or doctor by not providing enough care resulting in breach of their duties and harming the patients which are their consumers. Medical negligence has caused many deaths as well as adverse results to the patient’s health.

Civil Liability, i.e., monetary compensation can be imposed under the general law by pursuing a remedy before appropriate Civil Court or Consumer forums. There are various degrees of negligence and a very high degree of Gross Negligence is required to be proved beyond reasonable doubt for certain acts to be made punishable under the provisions of Criminal Law. As per existing Laws, cases for medical negligence caused by Doctors can be filed under following enactments at the option of the Patients:

• A complaint for deficiency of service can be filed before the Consumer Forum under the Consumer Protection Act, 1986.
• A Civil Suit for the Recovery of Damages in the appropriate Civil Court.
• A complaint under Section 304–A of the Indian Penal Code, 1860 in the appropriate
• Criminal Court.
• A complaint to the Medical Council of India or The State Medical Council for de registration of a doctor on account of negligence.

Q99. “A pedestrian is knocked down by a vehicle at a junction in a town. A group of people immediately rushed him to a nearby private hospital. The hospital administration refuses to provide treatment. Whether refusal is legally permissible? Cite relevant precedent.

The hospital administration cannot refuse to provide treatment in emergency cases. Hospital cannot insist on Prior filing of FIR with the police and then start treatment. First, immediate treatment or first aid must be given and then it is the duty of the hospital administration to inform the police about the possible accident or unnatural injuries suffered by the victim.

A physician attending the case is expected to exercise a reasonable prudent physician standard of care and offer that much of help as is possible under the circumstances.

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Q61. What is therapeutic privilege and it is exception to which doctrine?

Providing patients with information is fundamental to respecting autonomy. However, there may be circumstances when information may be withheld to prevent serious harm to the patient, a concept referred to as therapeutic privilege. “Therapeutic privilege,” also known as “therapeutic nondisclosure,” is defined as the withholding of relevant health information from the patient if nondisclosure is believed to be in the best interests of the patient.

Nondisclosure directly impairs patients’ autonomy by limiting their ability to make decisions about their own medical care. It also has the potential to undermine the patient’s trust in the physician and to preclude the patient from creating meaning out of illness and making plans and decisions with a realistic understanding of the future. Given these significant potential harms and the moral duty to tell the truth, the justification for nondisclosure must be extremely compelling.

 Therapeutic privilege (TP) is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm.

Q62. What are the principles of Disaster Management Plan?

An ideal disaster management plan involves the following:

• Initial alert: All persons in danger must be alerted in a manner that is simple and concise and yet audible and loud enough to reach every nook and corner of that place. Bells, sirens, public address system can be used for the same. Necessary dos and don’ts to be conveyed to affected people.
• Quick intimation to agencies providing assistance: Fire brigades, hospitals, medical, paramedical staff should be intimated at the earliest and ask them to be ready for any eventuality and load.
• Code alert: Different coloured flags are used on sea shore to show danger level of cyclones.
• Rehearsal and mock drill: Rehearsal and mock drill should be performed when situation is normal this helps working effectively during actual crisis.
• Common nucleus: There should be central control room to coordinate the activities and administration during crisis.
• Accurate Information: It should be made available on timely basis through media.

Q63 Medico legal aspect of road accident, discuss what investigation must include?

A traffic or road accident is defined as an accident involving at least one vehicle on a road open to public traffic in which at least one person is injured or killed. The main cause of accidents and crashes are due to human errors. Most of the road users are quite well aware of the general rules and safety measures while using roads but it is only the laxity on part of road users, which cause accidents and crashes.

The Investigation of the accident must be done as soon as possible after it occurs because it helps in observing the conditions as they were at the time of the accident. Investigation officer may take help from an automobile expert and a medical expert. Establishment of facts includes visiting site of accident, examination of mechanical damages. If the driver of the vehicle is survived, his medical examination is mandatory. It should be ascertained if he was under the influence of alcohol or drugs at the time of accident. Medical examination of the victims must be conducted immediately. Medical examination includes noting of injuries suffered, place, angle, extent, and depth of injury. It also includes noting of blood stains on body, tears, grease marks, mud and soil stains, etc.

In case of accidental death, an autopsy (post mortem) is often performed to ascertain the cause of death. An autopsy or post-mortem is a surgical procedure involving a thorough examination of the corpse by dissection to determine the cause and manner of death. The procedure is performed by specialist pathologists.

Q64. “For any type of cold, rely on Caphoor Vaporub” This advertisement was published in a local newspaper. Some patient got relief. The unsatisfied ones, filed a case for compensation? Is advertisement liable for action. If yes mention the Act and Define it giving appropriate Case Law? Does the Act infringe any Constitutional Right?

Yes, the advertisement is liable for action under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

This advertisement cannot escape the liability due to right to speech under Article 19 of the Constitution. Even the action does not violate the right to choose profession.  The appropriate case is Dr. Malpani Infertility Clinic Pvt. Ltd. v. Appropriate Authority

Q65. Discuss Charak Samhita and Sushruta Samhita?

Charak Sanhita:

Ayurveda often referred as “the mother of all healing”, is an ancient Indian system of healing. It is 5000 to 10000 years old. Major books on this system are Charak Sanhita and Sushruta Sanhita. “Charak Sanhita” is a massive compilation containing several chapters on therapeutic and internal medicine. It contains reference to more than six hundred types of medications of plant, animal, and mineral origin. This collection is believed to date back to 400 – 200 BC and is the oldest and most important authorative text on this system of medicine. There is no confirmation whether it was the work of one scholar called Charak or a compilation made by a group of scholars who were followers of Charak. This compilation is in Sanskrit and is in poetic style. Its translation in English was made by P. V. Sharma and has been published in four volumes.

Sushruta Sanhita:

Ayurveda often referred as “the mother of all healing”, is an ancient Indian system of healing. It is 5000 to 10000 years old. Major books on this system are Charak Sanhita and Sushruta Sanhita. “Sushrut Sanhita” is an ancient scholarly work dedicated to surgery. In the whole world this is the oldest compilation on surgery. The book s written in the sixth century B.C. by an ancient Ayurvedic scholar “Sushruta”. The book contains descriptions of surgical procedures which are relevant even today. Modern surgeons get marveled at the achievements of surgeons in ancient India. This book convers various fields like anatomy, toxicology, embryology, and therapeutics. It has chapters on dissection and operative procedures, which are explained with reference to dead animals and plants. This book contains detailed procedures relating to the reconstruction of a fractured nose and broken ear lobe. Hence many claims origin of Plastic Surgery can be traced to this book.  It explained 101 type of blunt and 21 types of sharp surgical instruments like scalpels, forceps, specula, etc.

Q66. Mention the circumstances in which patient’s Right to Determination is overruled give case laws

When informed consent of the patient is not obtained before a surgery, the same would amount to offences of assault and battery. However, there are exceptions to this rule.

• If, for instance, an accused is in police custody and refuses to undergo medical examination (which would prove his guilt) in say, a rape case, the law allows reasonable force to be used to examine him medically, even if he refuses to consent to such a medical examination.
• If a patient is suffering from contagious disease, which is threat to society as a whole, then the law allows reasonable force to be used to treat such patient without his consent.

In Ananth Kumar Naik v. State of A.P., 1977 Cr.LJ 1797 case, the Court held that samples of blood and semen can be obtained in such cases, even if he objects to medical examination. Provisions of the Code of Criminal Procedure allows such a medical examination, and same does not violate Article 20(3) of the Constitution of India.

Q67. Why doctor resist the Consumer Protection Act, Discuss?

Doctors have resisted their inclusion within the scope of the Act for the following

1. Even before the Consumer Protection Act came into force, a doctor could be sued for negligence under the Law of Torts. Criminal negligence is also covered by the Indian Penal Code. Why then have another law which exposes doctors to further liability?
2. If doctors are covered by the said Act, they would become socially and legally liable to an unreasonable extent,
3. The relationship between a doctor and his patient is not of a commercial or trading nature and the provisions of the Act should not be applied in such case.
4. Litigation is bound to increase if one more forum is open to patents to sue their doctors.
5. Judges and the Members of the consumer courts are not trained in medical science and are thus not competent to decide such cases.
6. Acts of medical negligence are better understood and assessed by persons with medical training and not by persons who preside over consumer courts.
7. Medical Councils at the state and national level can take the disciplinary action against doctors in case of medical negligence and  unethical practices. Why then entrust the same job to consumer courts?
8. In order to justify a particular line of treatment later on in the court, doctors may recommend more investigations to be made and this would entail more delays and make the treatment more expensive.
9. Medicine being a noble profession, it is not fair that one more sword of litigation under the Act be kept hanging over the doctor. This would lead to more paper work before urgent medical or surgical treatment is given to the patient.
10. Doctors may have to spend more time in the courtrooms rather than in hospitals, clinics or dispensaries.

Q68. Mention the four components of negligence with appropriate case laws?

Four components of negligence are as follows:

1. Duty: The first element of determining negligence is whether or not the defendant owed the plaintiff a legal duty of care. There are situations where a legal duty is created in the relationship between the plaintiff and the defendant. A duty of care arises when the law recognizes a relationship between two parties, and due to this relationship, one party has an obligation to exercise the same level of reasonable care that another person in a similar situation would exercise. For example: you do owe a duty to act with reasonable care so that you do not physically injure others.
2. Breach of Duty: The next element is for the court to determine if the defendant breached this duty by doing or not doing something that an average person would do if they were in a similar circumstance. If the defendant owed a duty and did not fulfill that duty, then he or she is in breach.
3. Causation: The third element of negligence is causation. Causation requires a plaintiff to show that the defendant’s breach of duty was the cause of the plaintiff’s injury and losses. It relates to whether the defendant’s actions hurt the plaintiff.
4. Damages: Damages are the final element of negligence. Because the plaintiff suffered injury or loss which a reasonable person in that same situation could expect or foresee, monetary compensation may be the only form of relief for those injuries. Damages include medical care, lost wages, emotional turmoil and more.

Q69 “Have a child of your Choice. Come to “X” clinic. Sex of the foetus is assured”. This advertisement was published in a local newspaper. Many pregnant visited the clinic. Can action be taken under any Act? Mention appropriate case? What Propositions were laid down in the case of Canterbury v. Spence? Which Doctrine the case relate to?

Yes, action can be taken under the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994. Under this Act sex determination is prohibited. Similarly action can be taken under theDrugs and Magic Remedies (Objectionable Advertisements) Act, 1954. This advertisement cannot escape the liability due to right to speech under Article 19 of the Constitution. The appropriate case is Dr. Malpani Infertility Clinic Pvt. Ltd. v. Appropriate Authority

Canterbury v. Spence (1972 468 2d 772) Case:

The Court put forward following propositions:

• Every adult of sound mind enjoys the right of self determination, that is, he or she has the right to decide what shall be done to his or her body.
• It is the duty of the doctor to obtain, not just consent, from the patient, which patient gives after being informed of alternate lines of action and the risks involved in each of them.
• It is the duty of doctor to disclose to his patient all material risks which a reasonable man would consider to be significant, before the patient opts for the line of investigation or treatment.
• Therapeutic privilege, however, allows a doctor to withhold certain disclosures, if such disclosures could pose a serious threat of a psychological or physiological nature.
• When informed consent of the patient is not obtained before a surgery, the same would amount to offences of assault and battery.

The case relates to Right of Self Determination and Informed Consent.

Q70. Define Magic Remedy under DMR(OA) Act, 1954

According to Section 2(c) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, magic remedy‟ includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals.

Q71. Give two Examples of Medico Legal Case.

All cases of accidents, burns, assaults, alleged suicide or homicide, poisoning, road traffic accident, rape, drowning, etc shall be registered as medico legal cases (MLC).

Road Accident:

A traffic or road accident is defined as an accident involving at least one vehicle on a road open to public traffic in which at least one person is injured or killed. The main cause of accidents and crashes are due to human errors. Most of the road users are quite well aware of the general rules and safety measures while using roads but it is only the laxity on part of road users, which cause accidents and crashes.

The Investigation of the accident must be done as soon as possible after it occurs because it helps in observing the conditions as they were at the time of the accident. Investigation officer may take help from an automobile expert and a medical expert. Establishment of facts includes visiting site of accident, examination of mechanical damages. If the driver of the vehicle is survived, his medical examination is mandatory. It should be ascertained if he was under the influence of alcohol or drugs at the time of accident. Medical examination of the victims must be conducted immediately. Medical examination includes noting of injuries suffered, place, angle, extent, and depth of injury. It also includes noting of blood stains on body, tears, grease marks, mud and soil stains, etc.

In case of accidental death, an autopsy (post mortem) is often performed to ascertain the cause of death. An autopsy or post-mortem is a surgical procedure involving a thorough examination of the corpse by dissection to determine the cause and manner of death. The procedure is performed by specialist pathologists.

Rape:

Section 375 of IPC defines the term “Rape”.

A man is said to commit “rape” who, except in the case hereinafter excepted, has sexual intercourse with a woman under circumstances falling under any of the six following de­scriptions:—

(First) — Against her will.

(Secondly) —Without her consent.

(Thirdly) — With her consent, when her consent has been obtained by putting her or any person in whom she is interested in fear of death or of hurt.

(Fourthly) —With her consent, when the man knows that he is not her husband, and that her consent is given because she believes that he is another man to whom she is or believes herself to be law­fully married.

(Fifthly) — With her consent, when, at the time of giving such consent, by reason of unsoundness of mind or intoxication or the administration by him personally or through another of any stupe­fying or unwholesome substance, she is unable to understand the nature and consequences of that to which she gives consent.

(Sixthly) — With or without her consent, when she is under sixteen years of age.

Explanation: Penetration is sufficient to constitute the sexual intercourse necessary to the offence of rape.

Exception: Sexual intercourse by a man with his own wife, the wife not being under fifteen years of age, is not rape.

Section 53(5) of the CrPC talks about examination of a female victim, which should be done by or under the supervision of a female doctor. Section 53A of the CrPC provides for a detailed medical examination of a person accused of an offence of rape or an attempt to commit rape.

A detailed medical examination is to be carried out by a registered medical practitioner employed in a hospital run by government or local authority without delay. A “reasoned” report be prepared recording the name and address of the accused, the person by whom he was brought, the age of the accused, marks of injury if any, a description of materials collected from the accused for DNA profiling, etc.

Section 164(A) CrPC explains the legal requirements for medical examination of a victim of rape. One of the main elements of this is that the consent of the victim is mandatory and should be part of the report. It provides for a medical examination of the victim of rape by a registered medical practitioner preferably woman within 24 hours of incidence of assault.

Q72. Write Short Note – Female Foeticide

Female foeticide is the procedure of abortion to terminate a female foetus from the womb of the mother before taking birth after the sex recognition tests like an ultrasound scan. The census figures not only indicate the imbalance in the sex ratio, but it also indicates, the casual approach of society to all women. It is the cruellest on the part of society not to allow a female child to be born.

Major Reasons for Female Foeticide:

• Patrilineal line of succession
• Dowry system, violence against women
• Low status of women
• Preference for son due to financial security
• Small family norm
• Religious and social taboos
• Misuse of diagnostic techniques.

Impact of Female Foeticide:

• The sex ratio denotes the ratio of females to males in a specific region. As per the decennial Indian census, the Sex Ratio of India is 107.48. It means 107.48 males per 100 females in 2019.
• It increases number of crimes against women

Q73. Define Donor under TOHO Act 1994

Section 2(f) of the Transplantation of Human Organs and Tissues (TOHO) Act, 1994, defines donor as ““donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of section 3 of the Act”.

Q74. What is meant by “privileged communication‟?

A privileged communication is a conversation between two parties that is legally classified as a private discussion. This discussion is legally protected, and so cannot be disclosed to third parties. The concept is most commonly associated with a discussion between a doctor and a patient. It is called so because whatever information that is disclosed in this kind of setting is protected i.e., the courts cannot force the individual to disclose the details of such communication. 

Sections 122 to 129 of the Indian Evidence Act, 1872 contain provisions related to privileged communication. These provisions deal with what is called absolute privilege, and apply only to the specific instances covered by the sections. Communication between a doctor and his patient does not enjoy absolute privilege, but can be said to have relative privilege. The communication between a doctor and his patient can be communicated to other only in bona fide manner and abiding the rules of confidentiality and exceptions to it.

If doctor is sued for medical negligence by the patient, then the doctor may disclose information to the Court similarly if a doctor sues patient for non-payment of fees, the doctor can disclose information to the Court. If Court orders to produce medical reports containing confidential information, then the doctor is supposed to submit it to the Court.

Q75. What is meant by a patient’s rights to self-determination?

Article 21 of the Constitution is the basis of right of self-determination of patient. An adult patient who suffers from no mental incapacity has an absolute right to choose whether to consent to medical treatment. The protection of patient self-determination entails the following elements: (a) recognition of, and respect for, the patient’s right to decide what treatment to have or not to have; (b) provision of an enabling climate for the patient to make self-determined choices (ensuring effective communication and building trust); and (c) having regard for the context (social, cultural, emotional, etc.) in which the patient has to make his or her decision. The right of self-determination of the patient ought to be respected.

Two conditions are ordinarily required before applying the right of self determination. The individual has to have the relevant internal capacities for self-government and has to be free from external constraints. In a medical context, a decision is ordinarily regarded as autonomous where the individual has the capacity to make the relevant decision, has sufficient information to make the decision and does so voluntarily.

Where patients lack the capacity to make a decision, it follows necessarily that decisions must be made on their behalf. Very young children ordinarily have the majority of decisions made by parents and guardians. Where adults lack capacity, health care decisions are ordinarily made by the health professional in overall charge of their care, although adults can appoint someone to make decisions on their behalf.

Q76. Define “Genetic Counselling Centre‟ according to PCPNDT Act, 1994

According to Section 2(c) of the the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, “Genetic Counselling Centre” means an institute, hospital, nursing home or any place, by whatever name called, which provides for genetic counselling to patients.

Q77. State any three important provisions of Helsinki Declaration with respect to human experimentation of drugs

Medical research in humans depends on important ethical considerations to ensure the protection of the research subjects. The Helsinki Declaration is a statement outlining the ethical principles for medical research involving human subjects that was initially adopted by the 18th Assembly of the World Medical Association in Helsinki, Finland in June 1964. It was developed from 10 principles first stated in 1947 in the Nuremberg Code and further incorporated elements from the Declaration of Geneva (made in 1948), a statement of the ethical duties of physicians.

1. “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”
2. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
3. he primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
4. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
5. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

Q78. What is difference between ECG and EEG?

An electrocardiogram (ECG or EKG) is a medical test that detects heart problems by measuring the electrical activity generated by the heart as it contracts. Each beat of the heart is triggered by an electrical impulse generated from special cells in upper right chamber of heart. An electrocardiogram is a painless, non-invasive way to help diagnose many common heart problems in people of all ages. It is used to determine or detect:

• Abnormal heart rhythm (arrhythmias)
• If blocked or narrowed arteries in your heart (coronary artery disease) are causing chest pain or a heart attack
• Whether you have had a previous heart attack
• How well certain heart disease treatments, such as a pacemaker, are working

An electroencephalogram (EEG) is a test that detects electrical activity in human brain using small, metal discs (electrodes) attached to his scalp. The brain cells communicate via electrical impulses and are active all the time, even when asleep. This activity shows up as wavy lines on an EEG recording. An EEG is one of the main diagnostic tests for epilepsy. An EEG can also play a role in diagnosing other brain disorders.

Q79. Write Short Note – Brain Stem

Brain stem is the “stalk of the brain” which connects the spinal cord to various parts of the brain. It sends messages to the rest of your body to regulate balance, breathing, heart rate and more. It is very vital part of the body. Section 2(d) of the Transplantation of Human Organs and Tissues Act, 1994, defines brainstem death as ““brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3 of the Act.”

Identification of brain stem death carries important prognosis for the survival of the patient, because the heart may keep on beating for few days after brain stem death, or even for weeks if the patient is in the Intensive Care Unit of hospital with all forms of medical and cardiac support. The person cannot perform fundamental work of an organism. The person is practically dead but may have heart beat and such person may still able to breathe. Such brain stem death must be certified by a Board of Medical Expert referred to in Section 3(6) of the Act. The Board should contain

• the registered medical practitioner in charge of the hospital in which brain-stem death has occurred;
• an independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority;
• a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority: Provided that where a neurologist or a neurosurgeon is not available, the registered medical practitioner may nominate an independent registered medical practitioner, being a surgeon or a physician and an anaesthetist or intensivist subject to the condition that they are not members of the transplantation team for the concerned recipient and to such conditions as may be prescribed;
• the registered medical practitioner treating the person whose brain-stem death has occurred.

Q80. Explain international agencies and their role in disaster management.

With the world becoming a global village, the interdependence of nations has increased. In such a scenario, disaster assistance is acceptable as part of international relations. The overall concept of international disaster assistance is recognised by most nations as being valid, practicable and productive and has been accepted both by the victim and donor countries. The international agencies, UN organisations, Red Cross and Red Crescent, foreign governments and other agencies rush emergency assistance, with search and rescue operations, medical aid and relief supplies. International agencies render assistance at various stages from pre-disaster, response operations to recovery programmes as well as capacity building. The assistance encompasses all forms, including, formulation of plans at national and other levels, standard operating procedures, institution building, monitoring and warning systems, disaster assessment surveys, search and rescue, provision of emergency equipment and supplies, emergency communication facilities, medical teams, medical equipment and supplies, transport facilities, food, water purification plants, logistic facilities, expert guidance, training, shelter material, and financial grants or credits.

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Advertisement and media are playing a significant role in our daily lives. Drug industries also promote their products using such unscrupulous methods, such as misleading the buyer. Many products are brought into the market without much research and data-based credibility. However, their advertisements claim success stories and even have testimonials from people to vouch for them. Many of them claim make the users fairer, increase the height of children miraculously, reduce weight and cure some diseases like diabetes and cancer etc. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is an Act passed by the Parliament of India that regulates drug advertising in the country. The Act makes it illegal to market medications and treatments that claim to have magical powers, and it makes it a criminal offence to do so.

Need of the Act:

Before the enactment of this Act, there was no law to punish the unprincipled and unscrupulous people who were engaged in false advertisements and claimed miraculous health, particularly health.  The people were engaged in false advertisements of various drugs
and medical remedies were also advertised without any fear. Their advertisements not only possessed a threat to society at large but also to the people who believed in such advertisements and acted accordingly. The government enacted strict rules to prevent the self-medication by the consumers regarding various diseases and conditions.

Important Definitions of the Act:

• Advertisement: According to Section 2(a) of the Act, “advertisement” includes any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke;

• Drug: According to Section 2(b) of the Act, “drug‟ includes—
  • a medicine for the internal or external use of human beings or animals;
  • any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals;
  • any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals;
  • any article intended for use as a component of any medicine, substance or article, referred to in sub-clauses (i), (ii) and (iii);
• Magic Remedy: According to Section 2(c) of the Act, magic remedy‟ includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals;
• Registered Medical Practitioner: According to Section 2(cc) of the Act, “registered medical practitioner‟ means any person,—
  • who holds a qualification granted by an authority specified in, or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916) specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or
  • who is entitled to be registered as a medical practitioner under any law for the time being in force in any State to which this Act extends relating to the registration of medical practitioner;

Prohibition of Advertising of Certain Drugs for the Treatment of Certain Diseases and Disorders:

Under Section 3 of the Act, advertisement of following drugs is banned

• the use of drugs will either results in procurement of miscarriage of women or it will prevent the conception of the women; or
• the use drug will either results in the maintenance or improvement of the capacity of human beings for sexual pleasure; or
• drugs dealing with the menstrual disorder in women in; or
• drugs dealing with diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition which have been specified in the schedule or any other disease or condition as specified under the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

Prohibition of Misleading Advertisements Related to Drugs:

Section 4 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 provides that no person shall take a part in the publication of advertisement relating to a drug if that advertisement contains any one of the matters, as mentioned below which may result either:

• directly or indirectly gives a false impression regarding the true character of the drug; or
• is engaged in making a false claim for the drug; or
• Is engaged in misleading in any material particular.

Prohibition of Advertisement of Magic Remedies for the Treatment of Certain Diseases and Disorders:

Section 5 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 provides that no person shall be allowed to work on administering magic remedies and shall not engage themselves in the publication of the advertisement of magic remedies for the treatment of certain diseases and disorders as mentioned under Section 3 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

Prohibition Of Import Into, and Export from, India of Certain Advertisements:

Section 6 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 states no person shall be allowed to import or export from, any documents which are prohibited under Section 3, 4 and 5 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954.

Penalty For Contravention:

Section 7 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 states if any person contravenes the Act or any rules made under this Act are:

• For the first conviction, the person shall be liable for either imprisonment which may extend to six months or with fine or both if the situation arises.

• For the second time involving the same offence, the person shall be liable for either imprisonment which may extend to one year or with fine or both if the situation arises.

Jurisdiction to Try Offences:

Section 10 of the Drugs and Magic Remedies Objectionable Advertisement Act, 1954 states that no court inferior to that of a Presidency Magistrate of the first class shall be allowed to try an offence which is punishable under this act.

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Q41. Medico-legal aspects of road accident cases.

A traffic or road accident is defined as an accident involving at least one vehicle on a road open to public traffic in which at least one person is injured or killed. The main cause of accidents and crashes are due to human errors. Most of the road users are quite well aware of the general rules and safety measures while using roads but it is only the laxity on part of road users, which cause accidents and crashes.

The Investigation of the accident must be done as soon as possible after it occurs because it helps in observing the conditions as they were at the time of the accident. Investigation officer may take help from an automobile expert and a medical expert. Establishment of facts includes visiting site of accident, examination of mechanical damages. If the driver of the vehicle is survived, his medical examination is mandatory. It should be ascertained if he was under the influence of alcohol or drugs at the time of accident. Medical examination of the victims must be conducted immediately. Medical examination includes noting of injuries suffered, place, angle, extent, and depth of injury. It also includes noting of blood stains on body, tears, grease marks, mud and soil stains, etc.

In case of accidental death, an autopsy (post mortem) is often performed to ascertain the cause of death. An autopsy or post-mortem is a surgical procedure involving a thorough examination of the corpse by dissection to determine the cause and manner of death. The procedure is performed by specialist pathologists.

Q42. Legal issues faced by victims of Bhopal Gas leak tragedy

The Bhopal gas tragedy occurred in 1984 at Bhopal. On Dec. 3, a dangerous chemical reaction occurred in the plant. As a result, water entered into the tank containing methyl isocyanate gas. This resulted in the increase of temperature and pressure inside the tank. This led to the release of methyl isocyanate gas from the tank. The gas spread within the radius of eight kilometres. The gas caused coughing, breathlessness, stomach pain, burning in the respiratory tract. By the morning, thousand of people had died. Many people who survived this disaster, suffered from various diseases for the rest of their lives. People still suffer from cancer, tuberculosis, gynaecological disorders, etc. as the result of the inhalation of the gas.

In the February of 1985, the Indian Government filed a case in the U.S Court for a claim of $3.3 billons against the Union Carbide Corporation. But by 1986 all of these litigations in the U.S District were transferred to India on the grounds of forum non-convenient. It means that the case should be transferred to a more convenient forum so that the trial proceeds smoothly. Meanwhile in March 1985, the Bhopal Gas Leak Disaster (Processing of Claims) Act was passed which empowered the Central Government to become the sole representative of all the victims in all kinds of litigations so that interests of the victims of the disaster are fully protected and the claims for compensation are pursued speedily. In the year 1987, cases were filed in the Bhopal District Court which ordered the Union Carbide Corporation to pay 350 crores as interim compensation. Ultimately company appealed in the Supreme Court and company agreed to pay compensation of 470 million dollars.

Apart from these civil proceedings, criminal proceedings were also initiated before the Chief Judicial Magistrate in Bhopal. The proceedings were initiated under Section 304 A, and Sections 336, 337, and 338 read with Section 35 of the Indian Penal Code. Section 304 A deals with causing death by negligence. Sections 336, 337 and Section 338 deal with the offences of endangering life and personal safety of others. This is read along with Section 35 which deals with the aspect of common intention.

Q43. Role and functions of Indian medical council

Role and functions of Indian medical council are as follows:

• To lay down policies for maintaining a high quality and high standards in medical education and make necessary regulations in this behalf;
• To lay down policies for regulating medical institutions, medical researches and medical professionals and make necessary regulations in this behalf;
• To assess the requirements in healthcare, including human resources for health and healthcare infrastructure and develop a road map for meeting such requirements;
• To promote, co-ordinate and frame guidelines and lay down policies by making necessary regulations for the proper functioning of the Commission, the Autonomous Boards and the State Medical Councils;
• To ensure co-ordination among the Autonomous Boards;
• To take such measures, as may be necessary, to ensure compliance by the State Medical Councils of the guidelines framed and regulations made under this Act for their effective functioning under this Act;
• To exercise appellate jurisdiction with respect to the decisions of the Autonomous Boards;
• To lay down policies and codes to ensure observance of professional ethics in medical profession and to promote ethical conduct during the provision of care by medical practitioners;
• To frame guidelines for determination of fees and all other charges in respect of fifty per cent. of seats in private medical institutions and deemed to be universities which are governed under the provisions of this Act;
• To exercise such other powers and perform such other functions as may be prescribed.

Q44. Euthanasia

Euthanasia is described as the deliberate and intentional killing of a person for the benefit of that person in order to relieve him from pain and suffering. The term ‘Euthanasia’ is derived from the Greek words which literally means “good death” (Eu= Good; Thanatos=Death). Euthanasia is defined as the act of bringing the death of a person (patient) for the purpose of relieving the patient’s intolerable and incurable suffering. Typically, the physician’s motive is merciful and intended to end suffering. In voluntary euthanasia, a consent from the patient is taken. In non-voluntary euthanasia, the consent of patient is unavailable due to some reason.

In active euthanasia, the death of patient is brought directly by giving him a lethal dose of poisonous drug. In passive euthanasia, the life supporting system to the patient is discontinued and ultimately patient dies. In Aruna Shanbaug v. Union of India, the Supreme Court opposed active euthanasia but has given nod to passive euthanasia. The apex court also observed that right to life does not include right to die.

Q45. Right to health under the constitution of India

According to Article 21 of the Constitution of India “no person shall be deprived of his/her life or personal liberty except according to the procedure established by law. Right to life under Article 21 of the Constitution has been generously deciphered to mean something more than only human presence and incorporates the right to live with nobility and conventionality. The use of word ‘Life’ in Article 21 of the Constitution has a lot more extensive importance which includes human nobility, the right to livelihood, right to health, right to pollution free air, and so forth.

In the State of Punjab v. M.S. Chawla, it has been held that-the right to life ensured under Article 21 incorporates inside its ambit the right to health and clinical consideration. 

The Supreme Court in Vincent v. Union of India, held that a healthy body is the very establishment of all human activities. Article 47, a Directive Principle of State Policy in such manner lays pressure on the improvement of general health and denial of medications harmful to health as one of the essential obligations of the state.

Right to health should be considered with the right to medical care and the right to clean and pollution free environment.

Q46. Doctor patient confidentiality

If patient want to get a good treatment from a doctor he is expected to disclose all the details of his illness. Such information may be private and of personal nature and patient may like to disclose it to doctor only and not to others even not to relatives or friends. Now there is obligation on doctor not to disclose such information without obtaining prior permission from the patient. This expectation in medical field is called confidentiality in medical practice. If doctor fails to comply, the patient may ask for compensation on plea of breach of confidentiality. If assurance of confidentiality was not available, a patient hesitates to confide in his doctor, who in turn would not be able to give the best diagnosis or treatment.

A privileged communication is a conversation between two parties that is legally classified as a private discussion. This discussion is legally protected, and so cannot be disclosed to third parties. Sections 122 to 129 of the Indian Evidence Act, 1872 contain provisions related to privileged communication.

Sometimes public interest overrides the concept of confidentiality. If a patient is suffering from contagious disease and it is harmful to society as a whole. In such case the doctor has a duty to inform about the disease to health authorities in public interest.

In Mr. X v. Hospital Z, AIR 1999 SC 495 case, the apex court when commenting on infectious diseases held that in special circumstances, public interest would override the duty of confidentiality, as where there is an immediate or future health risk to the community or to a specific person.

Q47. Role and functions of ethics committee in clinical trials

According to the Drugs and Cosmetics rules, 1945. an Ethics Committee is a committee comprising of medical, scientific, non-medical and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyse and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.

If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.

Q48. Female foeticide

Female foeticide is the procedure of abortion to terminate a female foetus from the womb of the mother before taking birth after the sex recognition tests like an ultrasound scan. The census figures not only indicate the imbalance in the sex ratio, but it also indicates, the casual approach of society to all women. It is the cruellest on the part of society not to allow a female child to be born.

Major Reasons for Female Foeticide:

• Patrilineal line of succession
• Dowry system, violence against women
• Low status of women
• Preference for son due to financial security
• Small family norm
• Religious and social taboos
• Misuse of diagnostic techniques.

Impact of Female Foeticide:

• The sex ratio denotes the ratio of females to males in a specific region. As per the decennial Indian census, the Sex Ratio of India is 107.48. It means 107.48 males per 100 females in 2019.
• It increases number of crimes against women

Q49. Object of transplantation of human organs act, 1994

The objects of the Transplantation of Human Organs and Tissues (TOHO) Act, 1994 are as follows:

• To provide for the regulation of removal, storage, and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs.
• To illegalize the buying and selling of human organs and makes cash-for-kidney transactions a criminal offence.
• To establish an institutional structure to authorize and regulate human organ transplants and to register and regulate, through regular checks, hospitals that are permitted to perform transplants.

Q50. Brain stem death

Brain stem is the “stalk of the brain” which connects the spinal cord to various parts of the brain. It sends messages to the rest of your body to regulate balance, breathing, heart rate and more. It is very vital part of the body. Section 2(d) of the Transplantation of Human Organs and Tissues Act, 1994, defines brainstem death as ““brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3 of the Act.”

Identification of brain stem death carries important prognosis for the survival of the patient, because the heart may keep on beating for few days after brain stem death, or even for weeks if the patient is in the Intensive Care Unit of hospital with all forms of medical and cardiac support. The person cannot perform fundamental work of an organism. The person is practically dead but may have heart beat and such person may still able to breathe. Such brain stem death must be certified by a Board of Medical Expert referred to in Section 3(6) of the Act. The Board should contain

• the registered medical practitioner in charge of the hospital in which brain-stem death has occurred;
• an independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority;
• a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority: Provided that where a neurologist or a neurosurgeon is not available, the registered medical practitioner may nominate an independent registered medical practitioner, being a surgeon or a physician and an anaesthetist or intensivist subject to the condition that they are not members of the transplantation team for the concerned recipient and to such conditions as may be prescribed;
• the registered medical practitioner treating the person whose brain-stem death has occurred.

Q51. Right of self determination

Article 21 of the Constitution is the basis of right of self-determination of patient. An adult patient who suffers from no mental incapacity has an absolute right to choose whether to consent to medical treatment. The protection of patient self-determination entails the following elements: (a) recognition of, and respect for, the patient’s right to decide what treatment to have or not to have; (b) provision of an enabling climate for the patient to make self-determined choices (ensuring effective communication and building trust); and (c) having regard for the context (social, cultural, emotional, etc.) in which the patient has to make his or her decision. The right of self-determination of the patient ought to be respected.

Two conditions are ordinarily required before applying the right of self determination. The individual has to have the relevant internal capacities for self-government and has to be free from external constraints. In a medical context, a decision is ordinarily regarded as autonomous where the individual has the capacity to make the relevant decision, has sufficient information to make the decision and does so voluntarily.

Where patients lack the capacity to make a decision, it follows necessarily that decisions must be made on their behalf. Very young children ordinarily have the majority of decisions made by parents and guardians. Where adults lack capacity, health care decisions are ordinarily made by the health professional in overall charge of their care, although adults can appoint someone to make decisions on their behalf.

Q52. Disaster management plan

An ideal disaster management plan involves the following:

• Initial alert: All persons in danger must be alerted in a manner that is simple and concise and yet audible and loud enough to reach every nook and corner of that place. Bells, sirens, public address system can be used for the same. Necessary dos and don’ts to be conveyed to affected people.
• Quick intimation to agencies providing assistance: Fire brigades, hospitals, medical, paramedical staff should be intimated at the earliest and ask them to be ready for any eventuality and load.
• Code alert: Different coloured flags are used on sea shore to show danger level of cyclones.
• Rehearsal and mock drill: Rehearsal and mock drill should be performed when situation is normal this helps working effectively during actual crisis.
• Common nucleus: There should be central control room to coordinate the activities and administration during crisis.
• Accurate Information: It should be made available on timely basis through media.

Q53. Medical record

The term medical records refer to the systematic documentation of a patient’s medical history, treatment and care maintained by a doctor or a hospital or similar other institution. Nowadays these reports are maintained in electronic form and called Electronic Medical Record (EMR). These records serve two purposes.

• It documents entire medical history of patients including physical examination and the investigations done, diagnosis and treatment given to the patient.
• This information is important when the patient visits the doctor again for same disease or for routine check-up.

Utmost confidence is to be observed by the medical practitioner in maintaining such records, as they often contain sensitive medical information of the patient. Medical professionals are bound to maintain such records. If a physician does not maintain record of his individual patients for three years it is professional misconduct and punishable. Only Court can ask for medical reports from the doctor during a trial involving medical reference to the matter.

Q54. Medical certificate

A Medical Certificate is a written statement from a doctor or a qualified health professional who attests to the result of the medical examination of a patient. This written statement is required for many purposes but is most widely used as for sick leave, where it states that an employee is unfit for work due to health concerns or for fitness that, the person to whom certificate is given is fit. Medical certificates might also be required to access certain health benefits that are provided by an employer. Medical certificates are also used by students, excusing them from attending school for reasons of illness. Medical Certificates are very personal documents; hence it must respect a patient’s right to confidentiality. This means that the patients’ consent is required for sharing sensitive medical information.

Issuing medical certificates is integral responsibility of medical practitioner. He has right to issue medical certificates required

• by employers, schools, colleges, etc.
• to obtain passport or driving license
• under Factories Act, Vaccination Act, etc.
• to fulfil statutory requirements.

Regulation 7.7 of the Code of Ethics Regulation, 2002, states that registered medical practitioners are in certain cases bound by law to give, or may from time to time be called upon or requested to give certificates, notification, reports and other documents of similar character signed by them in their professional capacity for subsequent use in the courts or for administrative purposes etc.

Medical practitioner is supposed to maintain record of the medical certificates issued by him, giving full details of the certificate. It is found that some medical practitioners issue false medical certificate.

Q55. Who can give consent for the donation of a human organ?

Organ donation is basically giving or gifting organ in order to help someone who needs organ transplant to be operated, it could be near relative or any other person.

According to Section 2(f), “donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of section 3 of the Act”. Under the virtue of Section 3 of the Act, Donor would fall under the following two categories;

• Living Donor: any person not less than 18 years of age, who voluntarily authorizes the removal of any of his organ and/or tissue, during his or her lifetime solely for therapeutic purposes.
• Deceased Donor: Anyone, regardless of age, race or gender can become a donor of any organ and/or tissue after his/her death (Brainstem/Cardiac). A person who is in lawful possession of the dead body or the free consent of ‘near relative is required for the said purpose. If the deceased donor is under the age of 18 years, then the consent required from one of the parents or any near relative authorized by the parents is necessary.

Under section 2(i) of the Act, ‘near-relative’ means spouse, children, grandchildren, brother-sister, parents and grandparents of the patient can donate the organ after taking prior permission from the doctor in-charge of the transplant center to donate his organ. A non-related donor needs prior permission of Authorization Committee established by the state under the Act in order to donate his organs.

Q56. Indian medical association V/s. V. P. Shantha

Indian Medical Association v. V.P. Shantha AIR 1996 SC 550:

Issues:

• Whether a medical practitioner, hospital, or nursing home can be regarded as rendering service under Section 2(1)(o) of the Consumer Protection Act, 1986?
• Under what circumstances can the service render at a hospital/nursing be regarded as service under Section 2(1)(o) of the Consumer Protection Act, 1986?

The ratio decendi of the case is medical negligence. Medical negligence is basically the misconduct by medical practitioner by not providing enough care resulting in breach of their duties and harming the patients which are consumers. They also argued whether this was the case of negligence in Torts or IPC, later on it was decided that any negligence in medical field would be determined under CPA, 1986. The Supreme court also stated that a medical practitioner, nursing home or a hospital can be regarded as rendering service under CPA, 1986.

As a result of this judgement, medical profession has been brought under the Section 2(1) (0) of CPA , 1986 and also , it has included the following categories of doctors/hospitals under this Section:

• All medical / dental practitioners doing independent medical / dental practice unless rendering only free service.
• All hospitals having free as well as paying patients and all the paying free category patients receiving treatment in such hospitals.
• Medical / Dental practitioners and hospitals paid by an insurance firm for the treatment of a client or an employment for that of an employee.

Q57. Ayurveda

Ayurveda often referred as “the mother of all healing”, is an ancient Indian system of healing. It is 5000 to 10000 years old. Reference of this system can be seen in the Rigveda and the Atharva Veda. “Ayur” means life and veda means “knowledge”, thus “Ayurveda” means knowledge of life. The medicines are mainly plant based.

Diagnosis in Ayurveda takes in the form of general physical examination, involving examination of the pulse, tongue, eyes, vein sans faeces. Regulation of diet as a therapy plays an important role in Ayurvedic treatment.

Major books on this system are Charak Sanhita and Sushruta Sanhita. This system has holistic approach of treating the patient.  “Charak Sanhita” is a massive compilation containing several chapters on therapeutic and internal medicine. It contains reference to more than six hundred types of medications of plant, animal, and mineral origin. “Sushrut Sanhita” is an ancient scholarly work dedicated to surgery. In the whole world this is the oldest compilation on surgery. The book is written in the sixth century B.C. by an ancient Ayurvedic scholar “Sushruta”. The book contains descriptions of surgical procedures which are relevant even today.

Doctrine of Ayurveda:

Body is made up of Pancha Mahabhootas: Prithvi (earth), Jal (water), Agni (fire), Vayu (air) and Akash (ether). There are three doshas in the body: Tridosha: The Vata (ether + air), Pitta (fire) and Kapha (earth + water) and Trigunas: the Satva, Rajas and Tamas, which are the psychological properties

Any imbalance in above factors due to internal and external factors causes disease and restoring equilibrium through various techniques, procedures, regimes, diet and medicine constitute treatment. Over the years, Kshar Sutra and Panchakarma therapies of Ayurveda have become very popular among the public.

Q58. Right of registered medical practitioners

Medical practitioner has following rights:

• Right to choose his patients
• Right to use his titles and qualifications
• Right to receive and recover fees and expenses
• Right to get appointed in Hospitals and Institution
• Right practice medicine and dispense medicine
• Right to issue medical certificates
• Right to Give Evidence
• Right to remove organs and tissues from a dead body
• Right to perform medical termination of pregnancy
• Right to disclose confidential information in exceptional circumstances
• Right to disclose and report injuries
• Right to access information
• Right not to be unfairly discriminated
• Right to have political views
• Right to refuse to conduct an unlawful bodily search or seizure

Q59. Authority under the transplantation of human organs act

The Central Government is empowered by the Act to appoint, by notification one or more officers as the Appropriate Authority for the purposes of the Act, for each of Union Territories. Likewise, every State must by notification, appoint one or more persons as the Appropriate Authority of that State.

Functions of Appropriate Authority:

Section 13 of the Act gives functions of the Appropriate Authority under the TOHO Act, 1994.

• to grant registration under sub-section (1) of section 15 or renew registration under sub-section (3) of that section;
• to suspend or cancel registration under sub-section (2) of section 16;
• to enforce such standards, as may be prescribed,— (A) for hospitals engaged in the removal, storage or transplantation of any human organ: (B) for Tissue Banks engaged in recovery, screening, testing, processing, storage and distribution of tissues;
• to investigate any complaint of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action;
• to inspect Tissue Banks periodically;
• to inspect hospitals periodically for examination of the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed; and
• to undertake such other measures as may be prescribed.

Q60. Mens rea in medical negligence

A tort is a residuary civil wrong. Duties in tort are fixed by the law and such duties are owed in rem or to the people at large generally.  Such wrongs can be remedied by filing for unliquidated damages. Negligence is a tort. A 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. Medical Negligence basically is the misconduct by a medical practitioner or doctor by not providing enough care resulting in breach of their duties and harming the patients which are their consumers. Medical negligence has caused many deaths as well as adverse results to the patient’s health.

The concept of mens rea is not applicable in torts. If doctor’s rash or negligent act endangers human life or personal safety of his patient, he can be tried for criminal liability. In Jacob Mathew case the Court held that in criminal law medical professionals are placed on a pedestal different from ordinary mortals. It was further held that to prosecute the medical professionals for negligence under criminal law, something more than mere negligence had to be proved. Medical professionals deal with patients and they are expected to make the best decisions in the circumstances of the case. Sometimes, the decision may not be correct, and that would not mean that the medical professional is guilty of criminal negligence. Such a medical professional may be liable to pay damages but unless negligence of a high order is shown the medical professionals should not be dragged into criminal proceedings.

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