Sunday, April 27, 2008

Deaths Due to Compulsory Vaccination

The news of death of 4 infants after measles vaccination at a medical camp in Tiruvallur district in Tamil Nadu (TOI, April 24, 2008) is poignant not only for the deep sense of deprivation that the parents of the children must be experiencing but also on account of the fact that episodes of such tragedy do no more than capture the headlines of print and electronic media without matching remedial measures to prevent its recurrence. The nurses have been suspended, notices will be sent to the Institute which has supplied the batch of vaccines and the Chief Minister has announced ex gratia payments to the families of victims. Ad hocism is a cultivated trait of our bureaucracy that no one has any time beyond raising a mild whimper.
The health policies of government and sometimes the directives of International health organizations, like WHO, may dictate the adoption of vaccination against polio, small pox, measles etc. The massive scale of operation may include administration of drugs at school, at Railway Stations and many other public places with a degree of persuasion that the recipient may not be able to repel. In some cases, the drug administration may not require that recipient of the drug any consent that may seem to violate the fundamental precept of autonomy to accept or reject the administration of the vaccine. There have been no reported case laws from Indian Courts regarding legal actions arising out of compulsory vaccinations. Several legal issues relating to vaccination have been examined at various times in USA. The judgments highlight the dilemma faced by patients while balancing the risks of drug administration to perceived health benefits.
In the earliest case before the Supreme Court of USA in Jacobson v Massachusetts (197 U.S. 11 (1905)), the issue was, in response to concerns about smallpox, the Board of Health in Cambridge, Massachusetts adopted a regulation in 1902 that all the inhabitants of the city shall be successfully vaccinated and any adult over twenty-one years of age and not under guardianship [who] refuses or neglects to comply with such requirement shall forfeit five dollars. Jacobson, an adult resident of Cambridge, refused to be vaccinated and pleaded not guilty at his arraignment. The U.S. Supreme Court said that they were unwilling to hold it to be an element in the liberty secured by the Constitution that one person, or a minority of persons should have the power to dominate the majority when supported in their action by the authority of the State.
The US courts have also consistently held that no consent is necessary for administration of compulsory vaccination measures. Mazur v. Merck was a Pennsylvania case involving a 13-year-old girl who suffered irreversible brain damage associated with measles vaccine received during a mass vaccination programme at school. The court, like all U.S. courts, described vaccines as "unavoidably unsafe" and said that vaccine manufacturer Merck & Co. adequately warned of risks in its package insert, although the parents, like most American parents, were not given this insert. Because the manufacturer sold the vaccine to the federal government (Centers for Disease Control and Prevention), who rarely can be sued, the vaccine manufacturer prevailed, leaving the parents solely responsible for the care of their now mentally retarded daughter, even though they withheld permission for her to be vaccinated. In 1944 the U.S. Supreme Court stressed "that the state has a wide range of power for limiting parental freedom and authority in things affecting the child's welfare; and ... this includes, to some extent, matters of conscience and religious conviction" (Prince v. Massachusetts, 321 U.S. 158, 167 (1944).) The court specifically mentioned vaccination as an area in which the government may override parental consent. Manufacturers of drugs may throw a protective ring of disclaimer from being proceeded against. The product package insert may warn the potential subjects of vaccinations of the uncertainties surrounding the product. Perhaps, the warnings may not themselves insulate the manufacturers against legal claims but they substantially open an avenue for defence that is good for lasting a life time in Indian Courts.
Kristine M. Severyn, a noted medical researcher in USA writes, “Although the road to a disease-free world may be paved with good intentions, the practice of injecting multiple vaccines, with known and unknown risks, into healthy babies appears unethical if proper informed consent is dismissed in the process”. In a recent judgment of the Supreme Court (Sabira Kohli v Prabha Manchanda (2008)), the Supreme Court said that the concept of ‘informed consent’ as was being applied in USA will have no place in India, given the fact that patients are generally illiterate and may not understand all the relative merits and demerits of medical treatment and the choices available. It applied however the principle of ‘standard medical practice’ to test the validity of actions of a medical practitioner and see the treatment in the context of what is usually suggested by medical professionals and what the preponderance of medical opinions pointed at, while judging anyone medical treatment. The standard medical practice and the health policies of the Government definitely approve of compulsory vaccination against small pox, cholera, hepatitis, etc. There shall also be a law that makes possible strict liability regime against the government that administers the health policy and drug manufacturers, in the manner that USA has enacted a National Childhood Vaccine Injury Act as early as in the year 1980. Let the spectacle of wailing parents arising out of such tragedies be tempered with possibility of a recourse that is not dole-based but established on firm legal basis.

Sunday, April 20, 2008

Whose property is it anyway?

Is there a property in a dead body? The question is not in the realm of philosophy but in law. The heritability, transferability, ownership and the value of a thing are the property that we are talking about. The person that is dead cannot be the owner of his own body since the component of enjoyment is absent. The legal heirs do not inherit it as property since the idea of possessing it as a thing of value does not exist. It may be illegal to transact in a dead body and hence to talk about its transfer would be unheard of. There is no title in a corpse to own it. All that the laws, especially the municipal/corporation laws, guarantee is the right of the nearest relative to take possession of a corpse for burial or cremation. Ever since the advancement in science recognizes the possibility of organ transplantation from a dead person, dead body has become a thing of value. Scarlett, a teenager, was found dead in Callangute beach in Goa. A month after the body was flown to UK, her mother has claimed that the autopsy has revealed that her kidneys, stomach and uterus are missing and she will get back to India to pursue her fight for justice.
The Anatomy Act of 1949 was a model legislation that was passed by the Indian Parliament which was adopted with minor modifications in all States. The object of the legislation has been to provide for supply of unclaimed bodies of deceased persons to teaching medical institutions and hospitals for the purpose of anatomical examination and dissection or medical relief or treatment. When there is any doubt regarding the cause of death, the Act also provides that the unclaimed body to be referred to the police officer under section 174 of the Code of Criminal Procedure, 1898. Pending receipt of any claim, the dead body shall be removed to the hospital or the teaching medical institution for preservation from decay. Dead bodies which are received shall be kept temporarily in the cold storage of the Mortuary until they are removed to the Anatomy Department. In the Anatomy Department they shall be washed and preserved by means of formalin or glycerin solution. Those which are not required for immediate use shall be kept in a tank containing preservation solution. Once a body has undergone a process or other application of human skill, such as stuffing or embalming, it can, it seems, be the subject of property in the ordinary way. And the same goes for body parts. Thus in the grisly case of R v Kelly (1999) robbers who abstracted and sold preserved specimens from the Royal College of Surgeons' collection (UK) were held rightly convicted of theft. The right to the organs was recognized in the hospital and not to the relatives.
The Human Transplantation of Organs Act 42 of 1994 was passed by the Indian Parliament 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 and for matters connected therewith or incidental thereto. While commercial exploitation is an offence, mere removal of organs inside from a dead body does not appear to be an offence. R v Kelly threw an interesting sidelight when the accused was defending his act of removal of the organs on the ground that he loved dead bodies and he used the organs for making prototypes and sell them as exhibits of artistic value! There have been strange cases associated with dead bodies in various parts of the globe and the issues have come knocking at the portals of courts at various times. In re Organ Retention Group Litigation, [2004] EWHC 644 (QB), [2005] QB 506, the claimants in a group action were all parents of deceased children on whom post mortems had been conducted by doctors to establish the causes of death. The claimants alleged that, although they had consented to the post mortems, the organs of the children had been removed, retained and subsequently disposed of without their knowledge. The Queen’s Bench held that the removal and retention of the organs were lawful and the claimants' right of possession to the organs based on a duty of burial did not arise; and that, accordingly, there could be no action for wrongful interference with a body. However, it ruled that the claimants' case in negligence was held to be sustainable. It only arose in the context of hospital post mortems; that the evidence of doctors and the experts showed that doctors could owe a duty of care to a mother after a death of her baby on a doctor-patient basis; that once the doctor-patient relationship was established, the doctor owed a duty of care when seeking consent for a post mortem examination; that although the duty was to ensure non-objection, some explanation of what the parents were being asked not to object to must have been involved; that the duty of care extended to giving the parents an explanation of the purpose of the post mortem and what it involved including alerting them to the fact that organs might be retained; that the practice of not warning parents that a post mortem might involve the removal and subsequent retention of an organ could not be justified as a practice to be adopted in all cases; and that, in the circumstances, only one of the claims in negligence succeeded.
By Indian tradition and culture, the same human dignity (if not more), with which a living human being is expected to be treated, should also be extended to a person who is dead. Duties to protect the dignity of the human body after its death are deeply rooted in our nation's history. Recently, the Madras High Court upheld the claim of the father of a rubber plantation worker who died in Malaysia and whose body had been kept in the mortuary for 7 months and directed the Government of India to take steps to transport the body to India free of cost. When Scarlett's mother took the body of her daughter to UK, could it be said that she had a right to take merely the frame of her body sans the organs within it? Maybe, when we learn to treat the human beings with respect, we will have known to treat the dead body also with reverance

Sunday, April 13, 2008

No tear for the hoardings

Take a drive down the road in the early morning during monsoon, when the city sleeps, that is when the buildings are drenched in rain and look washed and clean. Or jog along on a wintry morning over the dew kissed meadow. Or think of an occasion when a beautiful painting remains draped by a curtain and someone pulls the strings that unfold the lovely manifestation of the objet d'art. Just as exhilarating was the experience when, thanks to the Supreme Court judgment vacating the order of stay of removal of hoardings and upholding the validity of Tamil Nadu Urban Local Bodies Licensing of Hoardings and Levy and Collection of Advertisement Tax Rules,2003, the hoardings came tumbling down. It all started with tearing away of the vinyl sheets with large iron frames standing tall. Next came those valiant men of the Chennai Corporation working on huge structures and shearing metal frames with gas cutters. Suddenly the buildings are visible; the trees look greener; the roads seem broader; the pavements are stumble-free.
Sparkling billboards are relatively a new phenomenon. Commercialization and consumerism fueled their growth to gigantic proportions. From drawings on walls, to paintings on large tin sheets to still larger colorful prints on vinyl sheets, they metamorphosed to powerful tools in your decision-making on the products you wished to consume. From roadsides, to arterial roads, to public property, to being mounted on tall private buildings, you could feel their ubiquitous presence at every turn. Again, from the single arc lamps, to colorful blinking lights, they arrested your attention and distracted you. From big to bigger to gigantic sizes, they clothed the buildings to a gaudy spectacle. Thanks to heritage activists and environmental friendly buddies, there were court restrain orders through enforcement of legislations.
Each state had its own problems. Metropolitan cities were the first sufferers. The objections at Mumbai came through a complaint- route targeting the hoardings as violating the Heritage Regulations for Greater Bombay, 1995. In a decision delivered by the Supreme court in 2005 in Mass Holdings Pvt. Ltd. v Municipal Corpn. of Greater Mumbai & Anr, it directed the removal of hoardings from Mahalaxmi precincts. In yet another case, the Bombay High Court ensured that a hoarding put up at the Tower of Silence (Zorastrian Crematorium) was removed on the ground that heritage sites could not be sullied. An Allahabad High Court judgment said that posters, hoardings and statutes on roads were a nuisance and directed in a judgment in 2005 that District Magistrates should make certain their removal, wherever they obstructed free flow of traffic. In the same year the High Court of Rajasthan initiated a suo motu proceeding which was in the nature of a public interest litigation directing the State of Rajasthan and other local bodies as to why hoardings were being permitted in Jaipur which were hazardous to traffic. The Supreme Court affirmed the directions and reiterated that Government was well within its powers to regulate licences regarding hoardings in a decision in 2006 in Jaipur Aloo Aaratiya Sangh and Ors. v State of Rajasthan and Ors. A decision in Punjab and Haryana High court in 2004 and still later a decision of 2007 from Delhi High Court frowned upon the hoardings as public nuisances and liable for removal. The Delhi Court decision was again affirmed by the Supreme Court. Tamil Nadu Rules are just as significant in that they prohibit grant of licences, (i) in front of educational institutions, popular places of worship and hospitals with inpatient treatment facility; (ii) in the corners of road or street junctions, up to a distance of 100 metres on either sides of the junction; and (iii) in front of places of historical or aesthetic importance.
Notwithstanding the consistent string of authorities expressing abhorrence to hoardings in public places and the State’s power to regulate their exhibition in public as well as private places, the particular industry has grown by court orders of stay. The judgment of the Supreme Court has not come a day too soon. The judgment has been delivered after a long gestation from the time when it was reserved for judgment. If you thought that the lackadaisical approach to helmet regulations, or auto meters were any indication to how the state government would enforce the judgment of the Supreme Court, you may be pleasantly surprised. The response from the government to the judgment has been phenomenal. The judgment had been delivered on a Thursday and the same night the hoardings were being removed. Be vigilant and make sure they do not come up.
There are sometimes, when you had rather wished that authorities do not act with such alacrity. The drive-in restaurant near the Gemini at Chennai is sadly closed. If you are a chennaiite, maybe, you had it as a venue for an amorous rendezvous, or for a business decision or held it as just a hangout with friends or as a weekend destination with your family. You may shed a tear or two, but don’t go overboard and break the gates open. If it is restored as a horticultural garden, would it not be good idea as a spot for the yearly parties of the Bar Association, but without speeches, shawls and garlands?