Dr. Caplan’s assertions to the contrary, vaccines are neither completely safe nor completely effective. In fact, from a legal standpoint, vaccines, like all prescription drugs, are “unavoidably unsafe.” [See, e.g., Bruesewitz v. Wyeth, 562 U.S. __ (2011).] Industry considered its liability for vaccine injury so significant that it lobbied Congress for the 1986 National Childhood Vaccine Injury Act, providing doctors and vaccine manufacturers almost blanket liability protection for injuries caused by federally recommended vaccines. [See Authorizing Legislation.] The liability risk was so serious that the federal government created a special tribunal under the 1986 Act, the Vaccine Injury Compensation Program, to pay the injured. Moreover, the Supreme Court in 2011 decided Bruesewitz v. Wyeth, prohibiting any individual from filing a civil suit for a defectively designed vaccine in any court in the country. Industry’s extraordinary protection against liability for vaccine injury does not correspond with glib statements, like those of Dr. Caplan, that vaccines are safe and effective. On the contrary, the law acknowledges that vaccines cause injury and death to some, with no screening in place to mitigate harm. Dr. Caplan notes that public health officials have “tried to debunk false fears about vaccine safety.” Yet the Institute of Medicine, one the country’s most prestigious health organizations, has acknowledged repeatedly that there are many known vaccine injuries, such as seizures from the measles-mumps-rubella vaccine, anaphylaxis from the meningococcal vaccine, and encephalitis from the varicella vaccine. Even more troubling than the identified injuries is the number of potential vaccine adverse effect relationships for which the evidence is not sufficient to either prove or disprove causality. [Committee to Review Adverse Effects of Vaccines, Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality (Kathleen Straton et al. eds., 2012).]
By Dorit Rubinstein Reiss, LLB, Ph.D.
Harvard Law Blogs
Dorit Rubinstein Reiss (LLB, Ph.D.) is Professor of Law at UC Hastings College of the Law. She has published articles on regulation and administrative law and teaches tort law. She is also a member of the Parents Advisory Board of Voices for Vaccines and writes the blog Before Vaccines.
In a guest post on this blog, Mary Holland, JD, suggests that there are no grounds for imposing tort liability on parents for failure to vaccinate alone, even if it led to another person being infected. Holland’s post is courteous and matter-of-fact, and there are certainly arguments for that position, especially the argument that common law rarely imposes a duty to act. But Ms. Holland did not make that case.
A. Absence of a Common Law duty
Ms. Holland correctly identifies that courts are reluctant to impose a duty to act or rescue. Our legal system accords great weight to personal autonomy and therefore hesitates to require people to act. However, there are exceptions to this general approach, cases in which courts do impose a duty to act, so identifying that this is a duty-to-act situation is the start of a discussion, not the end of it. Duty is a legal determination by the court, not an objective, observable phenomenon independent of human will; “‘duty’ is not sacrosanct in itself, but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection,’ Dillon v. Legg, 68 Cal. 2d 728, 730 (Sup. Ct. 1968), quoting Prosser. Various courts have imposed a duty to act on a psychiatrist who knows of a threat a patient poses to others (Tarasoff v. Regents of the University of California, 17 Cal. 3d 425, 551 P.2d 334, 131 Cal. Rptr. 14 (Cal. 1976)); on a host to protect social guests from defects on the premises (Rowland v. Christian, 69 Cal. 2d 108 (1968)); on friends on a “joint venture” to render assistance when the friend is injured (Farwell v. Keaton, 396 Mich. 281, 240 N.W.2d 217 (1976)). Legislatures, too, may impose a duty to act.
There are several ways to analyze duty. Using the traditional Rowland v. Christian, 69 Cal. 2d 108 (1968) factors, we balance, among others, “the foreseeability of harm to the plaintiff, the degree of certainty that the plaintiff suffered injury, the closeness of the connection between the defendant’s conduct and the injury suffered, the moral blame attached to the defendant’s conduct, the policy of preventing future harm, the extent of the burden to the defendant and consequences to the community of imposing a duty to exercise care with resulting liability for breach, and the availability, cost, and prevalence of insurance for the risk involved.” Out of all these factors, Holland’s analysis focused solely on the burden to the defendant, ignoring all the other considerations.
Holland’s arguments that the duty creates too high a burden are that the duty violates religious freedom – addressed in part B – and that vaccines are unsafe. To show vaccines are unsafe Holland refers to Bruesewitz v. Wyeth, 562 U.S. __ (2011), saying the court found vaccines “unavoidably unsafe”; note, however, the majority in that case actually rejected the application of that term to vaccine injuries: “… there is no reason to believe that §300aa–22(b)(1) was invoking it. The comment creates a special category of ‘unavoidably unsafe products,’ while the statute refers to ‘side effects that were unavoidable.’” That the latter uses the adjective “unavoidable” and the former the adverb “unavoidably” does not establish that Congress had comment k (where the “unavoidably unsafe” language originates) in mind. “Unavoidable” is hardly a rarely used word. Nowhere does the majority say or suggest that vaccines carry a particularly high level of risk. The Court actually speaks positively of vaccines’ contribution to public health and sees them as “victims of their own success.”
Holland uses the National Vaccine Injury Compensation Program (NVICP) as evidence vaccines are unsafe; if that is our measure of vaccine safety, vaccines are extremely safe. In the 24 years of its operation, since 1989, the program awarded compensation for slightly less than 3300 cases. As calculated elsewhere, this is less than 0.003% of the vaccine administered. The fatalities - not injuries – from motor vehicle accidents (35,900) and accidents around the home (65,200) were much more numerous in 2009 alone. Children are safer being vaccinated than driven in a car or being home. And Holland completely ignores the benefits from vaccinating, i.e. protection of the defendant’s own children against preventable diseases. Like driving or being at home, vaccines are not completely risk free. But serious harms from vaccines are rare and they provide benefits to the person vaccinated.
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The Alliance for Natural Health USA (ANH-USA) believes “informed choice” is crucial in weighing health-treatment options — especially vaccinations.
As Richard Gale and Gary Null have written: “Vaccines are suspensions of infectious agents used to artificially induce immunity against specific diseases. The aim of vaccination is to mimic the process of naturally occurring infection through artificial means. Theoretically, vaccines produce a mild to moderate episode of infection in the body with only symptomatic, temporary, and slight side effects.”1
- advocates for the freedom of choice to be vaccinated — or not.
- believes that no one — children, pregnant women, adults, the military, seniors—should be forced to be vaccinated.
- believes that for individuals to make up their minds about vaccination, they need accurate and impartial information.
- believes that informed choice is the best way to protect the right to decide about vaccination.
The vaccine industry owns a billion-dollar market but has meager proof of its products’ efficacy or safety. Consumers are entitled to know exactly what is going into their bodies — its benefits and risks — and how safe and how effective that substance is.
There is mounting evidence that many vaccines are unsafe due to harmful ingredients, such as thimerosal (mercury) and aluminum. We at ANH-USA are worried that some inoculations may do more harm than good, and are very concerned about the apparent lack of urgency among federal regulators when vaccinations result in disability or death.
As America’s infant mortality rate and the number of autistic and chronically diseased children rise, those responsible for inoculation schedules (the Centers for Disease Control and Prevention, the American Academy of Pediatrics and other organizations that are funded in part by vaccine manufacturers) fail to provide unbiased studies on the probable link between vaccines and illness in children. And yet, federal policy currently encourages — and in many cases requires — that all children receive up to 36 vaccines by the age of 18 months. We believe that parents have the right to refuse compulsory vaccinations and are entitled to make their own informed decisions about which inoculations, if any, they (and their children) receive.
Big Pharma drug companies get over $10 billion per annum from the vaccine industry. It is no surprise, therefore, that companies such as Merck and Eli Lilly are constantly developing new vaccines, fast-tracking them through safety checks, spending little or no time studying the long-term side effects and failing to investigate reports of injury caused by vaccines. Pharmaceutical companies treasure their bottom line above our health and the health of our children.
Why do the U.S. Food & Drug Administration, the CDC and other governmental agencies charged with protecting consumers allow drug companies to produce and distribute products that are tested inadequately and are sometimes even deadly?
The answer: Big PHARMA pays off researchers and top officials at the CDC. According to Rep. Dan Burton, R-Ind.: “They routinely allow scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines.” Dr. Sam Katz, a CDC committee chair, was a paid consultant for most of the major vaccine makers and was also part of the team that developed the measles vaccine. Dr. Neal Halsey, another CDC committee member, worked as a researcher for the vaccine companies and also received honoraria from Abbot Labs for his research on the hepatitis B vaccine.
What’s worse is that the drug companies then lobby these same agencies to make their vaccine compulsory. For example, in 2007, lobbyists for Merck tried to get its Gardasil vaccine mandated for sixth-grade girls in every state, despite 15,000 adverse-event reports, 3,000 injuries, 48 deaths and speculation that its long-term effects could include infertility.
The presence of thimerosal in vaccines is also troubling. Although it has been removed from some vaccines, this deadly substance (which is 49.6 percent mercury by weight) still remains in others, including the flu shot. During the 1990s, after 11 more vaccines were added to the children’s immunization schedule, 70 million children were inoculated with vaccines containing thimerosal. At the same time, autism rates skyrocketed.
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