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.