Article Title

Fixing the Flaws in the Federal Vaccine Injury Compensation Program





First Page



Hannah Bruesewitz was born on October 20, 1991. Her pediatrician administered doses of the [diphtheria, pertussis, and tetanus (DTP)] vaccine according to the Center for Disease Control’s recommended childhood immunization schedule. Within 24 hours of her April 1992 vaccination, Hannah started to experience seizures. She suffered over 100 seizures during the next month, and her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” Hannah, now a teenager, is still diagnosed with both conditions.

In 1995, Hannah Bruesewitz’s parents embarked on an unsuccessful fifteen-year odyssey through the courts. Claiming that Hannah suffered vaccine-related injuries for which she was entitled to compensation, her parents litigated her case in every available forum, culminating in their recent loss in the U.S. Supreme Court. Hannah’s parents first sought compensation, as they were required to do, under the National Childhood Vaccine Injury Act (Vaccine Act), a pioneering no-fault federal tort reform law that took effect two decades ago. The statute, preempting state product liability laws, mandates that all claims for compensation for injuries caused by the vaccines routinely given in the United States must first be brought and litigated in the U.S. Court of Federal Claims, with the Secretary of Health and Human Services (HHS) as the respondent. After exhausting this remedy, petitioners have the option of filing a civil action in state or federal court, on grounds not foreclosed by the Vaccine Act, against the manufacturer of the vaccine or the healthcare provider who administered it.

After the Court of Federal Claims rejected Hannah’s parents’ petition for compensation, her parents filed a civil tort suit against the vaccine’s manufacturer. The complaint was dismissed in large part by the District Court, which held that the Vaccine Act’s preemption clause forbids a claim against a vaccine manufacturer based upon a design defect, which was Hannah’s parents’ most promising remaining ground for relief. On February 22, 2011, the U.S. Supreme Court affirmed the dismissal.

Hannah’s case highlights a number of problems with the National Vaccine Injury Compensation Program (Vaccine Program or Vaccine Compensation Program) today. The program represented a legislative compromise involving the major interest groups working in the vaccine area, including vaccine manufacturers, physicians’ groups, healthcare providers, federal health agencies, and parent groups advocating on behalf of injured children. Now that the Vaccine Program has been operating for more than twenty years, we can reach several broad conclusions about its successes and failures in satisfying the objectives of these groups and the objectives of the legislation. First, it appears that the Program has been largely successful in providing excellent liability protection for the pharmaceutical industry that makes vaccines, as well as for the doctors and other healthcare providers who administer them. These groups have been extremely concerned about possible tort liability for alleged vaccine-related injuries. While the Vaccine Act has not entirely eliminated all potential tort liability for manufacturers and healthcare providers, it has significantly minimized such liability, particularly after Bruesewitz v. Wyeth. The interests of the federal health agencies involved in the vaccine area, including HHS, the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and several other agencies, have also been largely satisfied by ensuring a relatively constant supply of vaccines to the public and ensuring that a high number of Americans receive inoculations. However, the objectives of parents’ groups and other advocates for children and adults who have suffered serious injuries after receiving vaccines have not been satisfied. For persons who may have been injured by vaccinations, the need for expeditious, generous, and predictable compensation remains unmet. Moreover, the process of adjudicating vaccine cases today is seriously flawed and in need of repair.

In this Article, I will examine the process of litigating vaccine injury claims in the Vaccine Compensation Program. The adjudicative process has changed over time, such that the program has become much different today than it was when the law was first enacted. The Vaccine Compensation Program is also very different from the program that the Supreme Court described in Bruesewitz. In the Bruesewitz opinion, the Supreme Court characterized the underlying proceedings before the special masters as involving “informal adjudication” which moves quickly to final resolution within 240 days of filing “except for two limited exceptions.” The Court added: “Fast, informal adjudication is made possible by the Act’s Vaccine Injury Table . . . .”

These descriptions of the Vaccine Program would have been largely accurate when the Act was initially passed, but they are substantially inaccurate in describing how the program actually operates today. The adjudications today are typically not informal at all, virtually no cases are concluded within the 240-day deadline, and the Vaccine Injury Table, which was originally a central feature of the Vaccine Act and a key innovative provision of the Act, has been significantly changed and narrowed over the years so that today it plays only a limited role in Vaccine Act cases.

The Vaccine Injury Table lists the specific injuries that the court recognizes as presumptively caused by a vaccine and the specified time limit for the occurrence of the onset of each listed injury. When the Vaccine Program began, the overwhelming majority of cases that were litigated in the program involved the relatively simple question of whether the Table requirements had been satisfied. However, the situation today, and for the foreseeable future, is the reverse. The overwhelming majority of cases litigated in the program do not involve Table injuries. In these cases, petitioners are asserting only non-Table claims and must prove that the vaccine caused the injury.

There are a number of reasons for this, but the most important is that the Table was substantially modified and narrowed by the Secretary of HHS in 1995 through an administrative rulemaking proceeding. In addition, the nine vaccines added to the Table by the Secretary of HHS since 1988 generally have no specified Table injuries at all or have the immediate onset of anaphylactic shock as the only listed Table injury.

These changes in the Table have resulted in other major changes in the operation of the program. The cases are now substantially more difficult, complex, and time-consuming to litigate. The science is less clear, and the special masters have much more difficult and complex scientific disputes to resolve than they did for the relatively simpler Table injury claims. Both petitioners’ counsel and government counsel now need to search for experts in cutting-edge medical areas, such as genetics and neurology, where a great deal of uncertainty still exists. This contributes to a much more adversarial process than was supposed to exist in a program that was designed to be less adversarial.

The present focus of the Vaccine Program on virtually all off-Table cases has also resulted in a series of recent decisions from the U.S. Court of Appeals for the Federal Circuit, purportedly clarifying but sometimes confusing the standards that the special masters are required to apply in deciding off-Table cases. A number of the Federal Circuit’s recent rulings have observed that Congress intended compensation to be provided generously, and that “close calls regarding causation are [to be] resolved in favor of injured claimants.” To the contrary, other recent Federal Circuit rulings have emphasized the importance of strict compliance with traditional tort standards of causation. Such inconsistencies have illuminated the need for clear standards.

In this Article, I seek to evaluate what the Vaccine Compensation Program has accomplished and what it has not, assessing its evolution over the past two decades. I will also undertake a comparative assessment, evaluating the Vaccine Compensation Program in light of the experiences of other federal compensation programs that Congress has recently adopted.

This document is currently not available here.