Immunization Programs

In the 1950s, medical breakthroughs resulted in new vaccines to combat such diseases as polio and measles. States responded by requiring mandatory immunization for schoolchildren. One result was the near eradication of diseases that had previously been crippling or fatal. A second, unforeseen result was adverse side effects of the vaccines, which led to lawsuits against drug companies. Between the 1960s and late 1980s, millions of dollars in litigation forced drug manufacturers to retreat from the market and prompted government action to help protect companies and ensure their presence in the vaccine market. Concern has also been raised over this problem's effect on the development of a vaccine against AIDS.

The 1950s saw great successes in the battle against childhood diseases. For example, pioneering researchers Drs. Jonas E. Salk and Albert B. Sabin developed vaccines that brought the dreaded virus poliomyelitis under control. This revolutionary work meant that a once rampant disease now could be stopped with a simple inoculation. In 1952 alone, more than 57,000 cases of polio in the United States left approximately 21,000 people crippled; in 1985, only four cases of polio were reported in the nation. Measles was also effectively halted: it killed over 2,000 people in 1941 but only two in 1985. And by the end of the 1970s, smallpox was virtually eliminated around the world.

Not only the vaccines accomplished this success. Government action helped, by enabling the widespread inoculation of children. By the 1960s, states had begun administering vaccines to school-age children, and their programs ultimately became mandatory. As of 2003, each state requires parents to submit a proof of immunization before enrolling their child in school; thus, the majority of young children in the United States are inoculated against such diseases as measles, polio, mumps, meningitis, and diphtheria, pertussis, tetanus, and whooping cough.

Vaccines are never entirely safe. Side effects range from mild to serious—from swelling and fever to brain damage and death. These dangers were recognized early on. Between 1961 and 1963, federal agencies noted occasional serious side effects from polio vaccines. By 1964, the surgeon general's Special Advisory Committee on Oral Poliomyelitis Vaccine found that 53 cases of polio could apparently be linked to the three types of the vaccine.

Public health authorities have nevertheless consistently urged the continuation of vaccine programs, arguing that the extremely minor incidence of adverse side effects is far outweighed by the health and lives they preserve. The Centers for Disease Control estimates, for example, that 1 in 310,000 children is adversely affected by the diphtheria, pertussis, and tetanus (DPT) vaccine. According to the AMERICAN MEDICAL ASSOCIATION, one in 3.2 million doses of polio vaccine will cause paralysis, and one in 1 million doses of measles vaccine will cause brain damage.

Beginning in the 1960s, vaccine-related injuries produced expensive litigation. Aggrieved families brought suit against drug manufacturers, sometimes winning large damages awards. These suits proceeded on a number of theories: NEGLIGENCE, failure to warn, design defect, production defect, breach of WARRANTY, and STRICT LIABILITY. In 1970, for instance, Epifanio Reyes, the father of eight-month-old Anita Reyes, filed suit against Wyeth Laboratories, charging that the company's vaccine had transmitted paralytic polio to his daughter. He claimed strict PRODUCT LIABILITY, breach of warranty, and negligence. The jury returned an award of $200,000, and the verdict was upheld on appeal in Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir., 1974), cert. denied, 419 U.S. 1096, 95 S. Ct. 687, 42 L. Ed. 2d 688 (1974).

The lawsuits increased costs for drug companies, which, even when successful in court, faced increased expenses in liability insurance. Fearing greater losses in court, manufacturers fled the vaccine market. Between the mid-1960s and early 1990s, the number of vaccine makers shrank by half. The companies that remained drastically raised the price of vaccines: the DPT vaccine, for instance, sold for $1 a dose in the early 1980s, but had increased to $11 a dose by the end of the decade. The exodus of companies from the market left measles, mumps, and rubella vaccines each with only one manufacturer. This situation raised worries about the possibility of a critical shortage if one of these manufacturers left the market.

Companies were not the only target of lawsuits. In the mid-1970s, the federal government established a vaccine program called the National Swine Flu Immunization Program of 1976 (42 U.S.C.A. § 247 b(j)-(1), amended by Pub. L. No. 95-626, 92 Stat. 3574 [1978]), in anticipation of an onslaught of swine flu. To induce manufacturers to produce the drug, the act absolved them of all liability, and the federal government assumed all risk. The epidemic never materialized, but legal problems did. Plaintiffs alleging harmful side effects from the vaccine sued, and the government ended up paying out millions of dollars in settlements. In Petty v. United States, 740 F.2d 1428 (1984), for example, the Eighth Circuit upheld a damages award of some $200,000. The Court held that the warnings on the vaccine were inadequate.

Since the time of the swine flu immunization suits, courts and lawmakers have taken actions that have lessened the risks of liability facing drug manufacturers. Courts have restricted the grounds under which litigants can succeed in civil TORT actions. Where products are found to be unavoidably unsafe—having obvious benefits yet carrying certain risks—the courts have erected barriers to strict liability claims. The courts have presumed that certain vaccines are unavoidably unsafe and, in some jurisdictions, that warnings provided by drug companies are adequate as long as they meet FOOD AND DRUG ADMINISTRATION (FDA) standards. The Restatement (Second) of Torts mentions the rabies vaccine as one of the products that, "in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use," noting,

Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. (§ 402A comment k [1965])

Courts in most jurisdictions now follow this standard in determining liability in vaccine cases.

The finding that a vaccine is unavoidably unsafe does not mean that manufacturers are completely absolved of liability. Plaintiffs may still overcome the two barriers of unavoidable danger and compliance with FDA standards. To prevail, they must show that vaccine-related injuries or deaths could have been prevented. Two chief means exist: they must show that the drugmaker engaged in illegal activity or that the drugmaker failed to exercise due care in preparing or marketing the vaccine. Although both are difficult matters to prove, they can be established, as in Petty, in which inadequate warnings on the swine flu vaccine were found to be more significant than the fact that the vaccine was unavoidably unsafe.

Congress used a similar liability standard in groundbreaking federal legislation passed in 1986, the National Childhood Vaccine Injury Act (42 U.S.C.A. § 300aa-1 et seq. [1990 Supp.]). The act established a federal no-fault compensation program for victims. It sought to stem civil litigation by providing an alternative: rather than sue drug companies, families alleging injury or death due to a child's compulsory inoculation could file suit in the federal Claims Court. This alternative reflected not only legal but commercial realities: Congress hoped to maintain an adequate national supply of vaccines by relieving drug companies of risk. The law set the maximum damages award at $250,000, and required plaintiffs to first file suit in the Claims Court. If successful, plaintiffs could accept the award or reject it in favor of filing a separate civil action. Like the evolving standard in courts, this law protected defendant drug companies: their compliance with federal production and labeling standards is an acceptable defense against civil lawsuits, and no strict liability claims are allowed.

Judicial and legislative solutions have thus partially ameliorated the liability risks of drug manufacturers. But by the mid-1990s, concerns remained about the potential for marketing an AIDS vaccine if one was discovered. Some observers called for federal legislation to protect potential manufacturers of an AIDS vaccine, and two states—California (Cal. Health & Safety Code § 199.50 [West Supp. 1995]) and Connecticut (Conn. Gen. Stat. Ann. § 19a-591b [West Supp. 1994])—extended liability protection to them.

Despite the use of anthrax in October 2001 as a terror weapon, medical and national security experts have always considered the intentional spreading of smallpox to be a far greater danger. In the weeks after the terrorist attacks, the HEALTH AND HUMAN SERVICES DEPARTMENT sought emergency funding for bio-terrorist preparedness, which included urgent production of smallpox vaccine. Smallpox as a naturally occurring disease was declared eradicated in 1980 after worldwide inoculation programs had successfully defeated it. The United States halted smallpox inoculations in 1972, and those Americans who had them are probably no longer protected, according to medical experts. The active life of the vaccination was considered to be 10 years, though recent studies indicate protection may last longer. The GEORGE W. BUSH administration labored for months over the question of reinstituting vaccines. The vaccine itself can be deadly and is not advised for people with weak immune systems, people being treated for cancer, nursing mothers, pregnant women, very young children, or people who have or have ever had eczema or atopic dermatitis. People who live with someone at risk under any of these conditions also should not be vaccinated. Based on medical studies, experts estimate that 15 out of every 1 million persons vaccinated for the first time could face serious side effects. Several countries are suspected to have varying amounts of smallpox virus, including North Korea, Russia, China, Pakistan, and Iran. The United States had several vials of the virus, according to testimony before Congress, kept under tight security at the Centers for Disease Control and Prevention in Atlanta. A single infected person can spread smallpox. The last major outbreak in an industrialized nation was in Yugoslavia in 1972.

In December 2002, President Bush ordered a national smallpox vaccination program in the United States. Military personnel destined for deployment to the Persian Gulf, Central Asia, and Middle East regions were given the vaccine as states across the country prepared to vaccinate emergency medical and disaster personnel who might have to contend with an outbreak of

the disease. Under the plan, there would be voluntary vaccinations of first responders, the fire fighters, police and emergency personnel who are first on the scene at a disaster. Government officials estimated that there were about 10 million first responders nationwide. Secretary of Health and Human Services Tommy Thompson said that there is a stockpile of nearly 15 million doses of an established and licensed vaccine that has been used in the United States for decades. These doses were expected to be administered to military and service personnel. There are some 85 million doses of a new vaccine that would not be licensed until 2004, and that could be used in case of emergency. The Association of American Physicians and Surgeons issued a statement of support for the president's program. The American Nurses Association, whose members would be some of the personnel offered inoculations in the first phased, said there was insufficient information about the risks for their members to make a clear decision. Some private citizens have been vaccinated under experimental programs, but as of June 2003, the vaccine was not available to the general public.