The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.
Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.
Despite the effectiveness of the original DTP vaccine, it did frequently produce reactions in the children who received it. Fever (and fever seizures in those genetically predisposed), irritability, and sometimes frightening hyporesponsive episodes were seen. The side effects of the DTP vaccine were attributable to its pertussis component. The vaccine was produced using the whole pertussis organism in an attenuated state so that it could not cause the disease itself. Utilizing the whole organism, however, exposed the child to a large number of proteins, some of which were responsible for the fever and other side effects the vaccine produced. These deleterious reactions certainly paled in comparison to the dangers of the diseases themselves. Nonetheless, as the diseases prevented by the vaccine disappeared, parents began to take more seriously these annoying and often frightening reactions. Because some of these reactions were so frightening, including febrile, or fever seizures, many people began to believe the vaccine was responsible for more serious side effects, including brain damage and even death. As outlined in an earlier SBM post, the side effects of the original “whole cell” DTP vaccine (DTwP) were not, however, life-threatening and produced no long-term problems in those receiving it. In 2006, a retrospective case-control cohort study of more than 2 million children concluded there was no increased risk of developing encephalopathy following administration of the original DTwP vaccine1. But when encephalopathy or a new onset seizure disorder occurred in temporal association with the receipt of the DTwP vaccine, causation was often ascribed to it.
It was the escalating, yet unfounded fears surrounding the original DTwP vaccine that led to the emergence of the modern-day anti-vaccine movement in this country. In 1982, the shockumentary “Vaccine Roulette” appeared on a local NBC TV affiliate. It purported to show the child victims of the DTwP vaccine, housed in a dark and dismal chronic care facility, damaged by doctors and forgotten by society. The show awakened the nation to the alleged dangers of this vaccine, and the fear quickly spread like wild fire. Fear of the DTwP vaccine and of vaccines in general enveloped the nation, and lawsuits against vaccine manufacturers over a host of alleged reactions rained down upon the courts. This torrent of legal action threatened the future of the vaccination program in this country. While in 1979 there was only 1 DTP-related lawsuit, by 1986 there were 255, with a total of over $3 billion sought by claimants. This clearly was not sustainable for the vaccine industry, and in fact manufacturers went out of business. In 1967 there were 26 US manufacturers of vaccines. By 1980 this number had dropped to 15, and by 1986 there were only 3 companies still making vaccines in this country. Vaccine prices skyrocketed, and manufacturers found it difficult to obtain liability insurance.
With the future of our vaccination program at risk, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986 and established the National Vaccine Injury Compensation Program (NVICP). Funded by an excise tax on each vaccine component administered, the NVICP was designed as a no-fault, expedited process to compensate families who claim their child has suffered a vaccine-related injury. No proof of causation is necessary to be eligible for compensation. A child simply has to have a documented problem that occurred in the specified time frame following a vaccination, and that problem has to be on the of problems recognized by the NVICP as potential vaccine adverse events. Cases are reviewed by a Special Master, who makes a determination based on minimal evidence, with the primary goal being a prompt resolution. If a claim is successful, compensation is granted for medical, rehabilitation, counseling, special education, and vocational training expenses, and $250,000 when the claimed outcome is death. Patients may accept the ruling or take their case through the usual tort process by suing the manufacturer. However, a major aspect of this process, and the one which saved the vaccine program from total collapse in the 1980s, is the significant liability protection granted to the vaccine manufacturers. Before suing a vaccine manufacturer, a claimant must first go through the NVICP process, or the so called “Vaccine Court”. But if a parent rejects an NVICP ruling and decides to sue in court, the vaccine manufacturer is immune from liability, assuming they have complied with all regulatory requirements and have not committed outright fraud or other crimes in the manufacture of the vaccine. Most importantly, the NCVIA stipulates that,
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 after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
Setting aside for the moment the fact that there is no evidence the DTwP vaccine can cause any of the adverse events listed in the original table, the statement above gets to the heart of the Supreme Court’s ruling. Specifically, the ruling centered around the words “unavoidable” and “even though” in the above excerpt. In April 1992, when Hannah Bruesewitz received the vaccine that allegedly injured her, her diagnosis “residual seizure disorder” had just been removed from the NVICP vaccine injury table. Her claim was denied by the Special Master, although she was still awarded $127,000 for legal fees. The family rejected this decision, and instead brought the case against Wyeth (which had acquired Lederle) to Pennsylvania state court. The Breusewitz’s asserted that the vaccine was defective, that the manufacturer knew it could cause harm, and that they had knowledge of a safer vaccine but failed to develop or use it. The Pennsylvania court rejected this claim, citing that such design-defect claims were preempted by the Vaccine Act. The case then ended up in The Supreme Court which finally, this past Tuesday, upheld the intent of the NVICP to protect the vaccine supply by preventing lawsuits based on design-defect claims. The Supreme Court’s opinion, delivered by Justice Antonin Scalia, interpreted the word “unavoidable” as written in the Vaccine Act, to apply to the specific vaccine administered to a claimant, and not to other hypothetical, alternate vaccines that might or might not be more or less safe and effectve. Justice Scalia argued that the use of the words “even though” in the excerpt above implies that the unavoidability referred to in the Act applies to the specific vaccine that was administered, and not to some other potential vaccine. In other words, the Breusewitz’s claim that their daughter’s condition was avoidable because a safer alternative vaccine could have been given was ruled to be a misreading of the Vaccine Act’s intent. The Opinion asserts that exclusion of design defects from the Act was intentional. The fact that the NCVIA and the FDA spell out in detail the manufacturing method and the warnings and directions that must be provided by a vaccine manufacturer, while making no mention of vaccine design requirements is a clear indication that such an exclusion was intentional. It was the Court’s opinion that any other reading of The Act would require very difficult determinations of relative vaccine safety and efficacy. Justice Scalia points out that these determinations are rightly the domain of the FDA and National Vaccine Program experts, and not the courts.
The Supreme Court’s ruling in this case was a huge victory for the health and well-being of our Nation’s children, and the Court should be applauded for its good sense and clarity on the issue. Undoubtedly, those who eschew rationality and oppose vaccines will find fault with the ruling, and cling to the mantra of conspiracy and collusion. Sadly, the fear and misinformation spawned from the DTwP-era lives on today. As technology improved, a version of the vaccine containing an “acellular” pertussis component did eventually become feasible. The DTaP vaccine, as it was called, was introduced in 1996 and nearly eliminated reactions to the vaccine. But the damage was done. As the media and a splintered cadre of like-minded conspiracy and anti-establishment groups took up arms against vaccines in general, a new anti-vaccinationism took hold. We’ve since been through the Wakefield crisis, the thimerosal debacle, and many other dangerous vaccine myths, nourished along by the media and the anti-vaccine cartel. The consequence of this spreading fear is an increasing distrust of vaccines, and the development of pockets of underimmunization around the country. We are now seeing outbreaks of completely preventable childhood disease, and children have died as a result. This was an important ruling, but we have a long way to go before we can bring rationality to the public discussion and understanding of vaccines in this country.
1Pediatr Infect Dis J. 2006;25:768-773