Poisoned Needles

One of the most impressive stories of global human cooperation began in 1796 with a young dairymaid named Sarah Nelms.  The stories had been apocryphal, mere legends whose truth was suspect:  dairymaids did not get smallpox. 

Smallpox, of course, was one of the great scourges mankind has faced.  Evidence has been found for the disease in Egyptian mummies who died at least three thousand years ago.  Human history is rife with descriptions of smallpox decimating local populations when it was introduced to areas where it was previously unknown.  Smallpox epidemics in North America after introduction of the disease by settlers at Plymouth in 1633 are estimated to have had 80% fatality rates among the native population.  Similar results occurred later in Australia with aborigines.  Numerous isolated island settlements in both the Pacific and Atlantic had almost all of their native populations wiped out by the disease. 

The fact that dairymaids seemed to have a peculiar immunity to smallpox was remarkable, a consequence of the fact that they had frequently suffered from cowpox, a much less fatal disease.  It was Edward Jenner who recognized that deliberate infection with cowpox could serve as a way to protect against smallpox.  On May 14, 1796, he obtain matter from fresh cowpox lesions on the hands and arms of Sarah Nelms, using it to infect James Phipps, an eight-year old boy.  James developed fever, loss of appetite, and discomfort in his armpits — symptoms of cowpox — and recovered about a week and a half after being infected.  A couple of months later, Jenner infected him again, but this time with matter obtained from smallpox lesions, and no disease developed. 

It would take Jenner some years to persuade scientific colleagues that “vaccination” in this way — the word being derived from the latin “vacca” for cow and “vaccinia” for cowpox — could prevent the spread of smallpox.  He was ultimately vindicated.  The end result of his campaign came on December 9, 1979 (and endorsed by the World Health Assembly on May 8, 1980) with a certification that smallpox had been eradicated from the planet except for some small stores maintained for research purposes. 

On October 12, the Supreme Court of the United States will consider oral arguments in what is likely to be a pivotal vaccination case.  At issue is a portion of the National Childhood Vaccine Injury Act, originally passed in 1986 (42 U.S.C. §§ 300aa-1 – 300aa-34).  Aside from its independent relevance, the Vaccine Act is interesting because it can be seen as a case study for many current efforts to introduce broader tort reform prompted by the concern, popular in some circles, that compensation awarded in tort cases is excessive and that litigation is generally an ineffective mechanism for giving compensation. 

Vaccine cases have traditionally been handled under state law, particularly conventional products-liability law.  The Vaccine Act was intended to provide a substitute mechanism for compensating those who may have been injured by vaccines that they received.  At the time, there was active protest by the manufacturers of vaccines, who complained that the cost associated with lawsuit threats was too high and who threatened to cease production of vaccines because the economic risk was too great.  At the same time, those who were injured by vaccines were generally dissatisfied — the time taken to litigate claims and engage in settlement negotiations was long and the entire process was costly, still sometimes resulting in no compensation at all.  These are all arguments that are still currently made more broadly by advocates of broader tort reform. 

Congress created an administrative program that focuses on compensation to the victims of vaccine-related harms.  If a victim can demonstrate receiving a vaccination of a particular type listed in a special Vaccine Injury Table, he or she is awarded compensation, without regard to either fault or causation.  This takes place in the Office of Special Masters of the U.S. Court of Federal Claims, commonly called the “Vaccine Court.”  If the compensation is unsatisfactory or if no award is made, the possibility still exists to bring a tort claim.  The program thus attempts to strike a balance between allowing claims to be brought in the traditional manner, while at the same time offering an alternative that results in faster and more predictable claims being paid.  How much the program is used thus offers an interesting perspective on the success of such a tort alternative. 

In exchange for the essentially automatic awarding of claims, the Vaccine Act preempts tort claims arising from “unavoidable” injuries: 

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine … if the injury or death resulted from side effects that were unavoidable …

It is this provision that is at issue in the case being heard by the Supreme Court.

The fact that an injury is “unavoidable” from use of a product does not normally insulate the manufacturer of the product from having to pay damages when it injures someone.  Indeed, “design defects” of products frequently give rise to damages — it does not matter that the product was flawlessly produced in precise accordance with specifications and with extreme care; if it has a faulty design that injures people, there is still liability for the injuries. 

In 2008, the Georgia Supreme Court held that the Vaccine Act does not preempt all design defect claims — only those where the injurious side effects were unpreventable.  That decision can be read here.  In 2009, a federal appeals court ruled that all design-defect claims are preempted, i.e. even if it were possible to prepare a safer form of the vaccine, there is still no permissible state tort claim arising from use of the more harmful design. That opinion can be read here. 

While the issue the Supreme Court will consider appears at some level to be a narrow one in that it is a matter of resolving a disagreement over statutory interpretation, it has broader importance.  In the quarter century since it was passed, about two thirds of those applying for federal injury compensation have been turned away empty-handed.  The program was sold as one in which the adversarial nature of litigation claims was to be avoided, but critics suggest that proceedings before the Vaccine Court have turned out to be nearly as time-consuming, expensive, and contentious as traditional litigation.  Many thus consider this experiment in tort reform to have been a failure, and a decision on one of the Vaccine Act’s more important provisions by the nation’s highest court will help determine whether such a view is warranted.