This article was published in Scientific American’s former blog network and reflects the views of the author, not necessarily those of Scientific American
Yesterday, the Supreme Court ruled 6–2 in Bruesewitz v. Wyeth, a case involving parents' rights to sue vaccine manufacturers. Before getting into the particulars, here's some important background:
In the early 1980s, literally hundreds of lawsuits were filed in civil courts claiming children had been harmed by the whole-cell pertussis component of the diphtheria-pertussis-tetanus (DPT) vaccine. By the mid-1980s, the few remaining drug companies that distributed vaccines in the US were threatening to leave the market. In an effort to forestall the collapse of the US vaccination program, Congress passed the National Childhood Vaccination Act in 1986; one of the law's provisions was the establishment of what has come to be called the Vaccine Court. The formation of the court and the manner in which it operates is fairly complicated; here's the Cliffs Notes version from my book:
In 1986, when Congress established the framework for a compensation fund to simultaneously help people with vaccine-related injuries and shield manufacturers from crippling lawsuits, it did so with the assumption that a streamlined, broad-reaching program would give some stability to the country's immunization efforts. In order for the program to work according to plan, plaintiffs—or petitioners, as they were referred to—had to be able to navigate it with relative ease. To that end, the law established a specially formulated table of injuries ranging from chronic arthritis and persistent bleeding to anaphylactic shock and paralytic polio. So long as a given injury occurred within a defined period of time following the administration of a vaccine, the court would assume causality without petitioners needing to provide further evidence. This "no fault" standard was the most significant way in which the Vaccine Court functioned differently from the traditional legal system.The trade-offs for this relaxed evidentiary standard and the Court's promise of relatively quick resolutions were the program's pre-determined limitations: Awards for death and "pain and suffering" were capped at $250,000; the maximum reimbursement for legal costs was $30,000; plaintiffs who accepted the court's rulings lost the right to file suit in civil court; claims needed to be filed within three years of an injury's onset; and plaintiffs who rejected the court's decision faced severe restrictions on the conditions under which they could file future civil suits. [1]
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Yesterday's ruling involved a lawsuit filed by the parents of a girl named Hannah Bruesewitz, who received the third dose of her DPT vaccine in 1992. Shortly thereafter, she had a series of seizures and suffered long-term developmental damage. In April 1995, the Bruesewitzes filed a Vaccine Court claim--but as it happened, "residual seizure disorder" had been removed as a table injury for the whole-cell pertussis vaccine a month earlier. (For an excellent discussion of the Bruesewitzes' journey, see Vaccine author Arthur Allen's piece in Slate.) As a result, the Bruesewitzes' Vaccine Court case became a causation case -- i.e., they had to prove that Hannah's condition had been caused by the pertussis vaccine.[2][3] When they were unable to do so, they sued Wyeth, the vaccine's manufacturer, in state court in Pennsylvania. The case was eventually moved to the federal court system, which has ruled that the Bruesewitzes' suit could not proceed because of the 1986 law. The Supreme Court's decision upholding the federal court rulings marks the end of the legal road for the Bruesewitzes.[4]
The Bruesewitz v. Wyeth decision is, without a doubt, a victory for those concerned with the future of the country's vaccination program. It's also a decision I agree with. I do, however, think that there are legitimate issues related to the case that deserve discussion -- and one of the main ones was the subject of Sonia Sotomayor's dissent, which focused on the following language in the Vaccination Act:
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. §300aa–22(b)(1).
Specifically, Sotomayor addressed the "unavoidable" issue. By the time Hannah Bruesewitz received the DPT vaccine, it had been the most controversial childhood vaccine for several decades. In the US, an irresponsible 1982 TV broadcast titled "DPT: Vaccine Roulette" literally sparked the formation of the modern-day anti-vaccine movement. (I have an entire chapter about "Vaccine Roulette" in my book.)
While many of the fears regarding the whole-cell pertussis vaccine were off-base, it was, as Paul Offit told me, "the most reactogenic" vaccine in use, and was "the only whole cell, whole bacterial vaccine we've ever used in our nation's history." It had been well-known for years that it could cause seizures, high fevers, and fainting. In fact, my younger sister ran an extremely high fever after her first DPT injection, which she received in the late 1970s. In the early 1990s, not long after Hannah received her DPT vaccine, the pertussis component was changed from whole cell to acellular version.
Sotomayor's argument hinges on the use of the word "unavoidable" in the 1986 law. If, as the Breuewitzes claim, Hannah's seizures (and developmental disorder) were the result of her receiving the whole-cell pertussis vaccine, and if those seizures would arguably not have occurred had she received the acellular vaccine, would the whole-cell vaccine's "design flaws" truly have been "unavoidable"?[5] (Again, Arthur Allen addresses this--and the question of whether the change from the whole cell to the acellular vaccine has contributed to the recent rise in pertussis infections, which resulted in the deaths of ten children in California last year alone--in his piece.)
I think that question is a legitimate one, and one that deserves to be discussed. It is not, however, a discussion that is likely to occur -- and that is primarily because the hysteria surrounding vaccines and vaccine safety has reached such a pitch that it is virtually impossible to have any discussion that doesn't immediately become political fodder. This stems primarily from anti-vaccine activists (and those who prod them on), who seize on any acknowledgment by public health officials, doctors, or vaccine manufacturers that vaccines are anything less than 100 percent perfect, 100 percent of the time as some sort of admission that all vaccines are potentially unsafe all of the time.
[1] Today, the Court allows for the reimbursement of "reasonable lawyers' fees and other legal costs." There remains a $250,000 cap on "pain on suffering," but there is no upper limit on the amount of money claimants can receive to cover medical care and lost wages.
[2] Even for non-table injury cases, the burden of proof in the Vaccine Court is significantly lower than it is in the rest of the legal system. One of the judges on the Court described it as "fifty percent plus a feather," which is obviously quite different from "beyond a reasonable doubt."
[3] The Autism Omnibus Proceedings, which I also write about at some length, involved thousands of claims by parents that vaccines had caused their children's autism. Because autism is not a "table injury," the Omnibus Proceedings were set up to establish whether autism could, in some cases, be caused by vaccines. The answer was a resounding no.
[4] This does not mean that losing a suit in Vaccine Court means there are no further recourse: Petitioners can file an appeal and they can also file suit in civil suit.
[5] Again, and I can't stress this enough: The issue here is not particular to the Bruesewitz case because there is no proof that Hannah's injuries were caused by the DPT vaccine. Correlation and causation are not the same thing.
About the author: Seth Mnookin’s most recent book, The Panic Virus: A True Story of Medicine, Science, and Fear, examines the controversies surrounding autism and vaccines to explore how we decide what counts as truth. You can follow him on Twitter at @sethmnookin. His blog, as well as regular updates about the book and his public appearances, can be found on his website, www.sethmnookin.com.
The views expressed are those of the author and are not necessarily those of Scientific American.