What does tort litigation have to do with homeland security? A great deal, according to the U.S. Congress. In the recently enacted Homeland Security Act, Congress added several provisions dealing with vaccine-related tort claims.
These amendments broaden the definition of "vaccine," ensuring that almost all vaccine-related claims will be directed first to the federal no-fault compensation program. Although the changes were designed to put an end to a longstanding debate about a substance called thimerosal, the law potentially implicates numerous other claims, putting an end to attempts to circumvent the federal system.
Less than two decades ago, the United States faced the real danger of losing the battle with preventable childhood diseases. In the mid-1980s, alarming media reports questioned the safety of many vaccines, spurring exponential increases in tort suits against manufacturers and forcing many to simply halt production.
Dwindling supply led to a drop in immunization rates across the United States. With rates hovering around 60 percent, Congress acted to avert a potential catastrophe by passing the National Childhood Vaccine Injury Act of 1986.
The most important product of the 1986 act is the National Vaccine Injury Compensation Program, which became effective on Oct. 1, 1988. Designed to ensure a stable vaccine supply while fairly compensating individuals suffering from vaccine-related injuries, the program performs a unique service: "For injuries and deaths traceable to vaccinations, the Act establishes a scheme of recovery designed to work faster and with greater ease than the civil tort system." Shalala v. Whitecotton, 514 U.S. 268 (1995).
The program provides a no-fault system for compensating injured children, funded by a surcharge on every dose of vaccine sold. Before filing a traditional tort suit, plaintiffs must apply for compensation in the Court of Federal Claims, where petitions are assigned to a special master familiar with vaccine-related injuries.
For a vaccine-related death, the program will offer to pay up to $250,000. For a vaccine-related injury, the program will pay for all past and future unreimbursed medical expenses, loss of earned income and up to $250,000 for pain and suffering. The program also provides for costs and attorney fees regardless of whether compensation is awarded.
If a plaintiff is dissatisfied with the compensation offered, the plaintiff may reject the award and pursue a traditional tort suit. The program has contributed to steadily increasing child immunization rates, which reached an all-time high in the late 1990s.
Nevertheless, the program has not been without controversy. The issue of which tort claims the program covers, for example, has been the subject of much litigation. Since the program only applies to those who have sustained a vaccine-related injury or death, some judicial decisions have determined that the program does not bar the tort suits of family members.
And while the program undisputedly applies to all vaccines set forth in the vaccine injury table found in the Code of Federal Regulations, it specifically excludes intentionally added "contaminants" and "adulterants." This is significant because, until recently, the distinction between proper vaccine components and improper contaminants was unclear.
The prevailing example is thimerosal, a mercury-based preservative found in many vaccines. Although the science is currently inconclusive, plaintiffs' attorneys long have argued that thimerosal causes child autism. Some plaintiffs seek to avoid the program's procedural requirements and compensation limits by claiming thimerosal is a vaccine contaminant.
Defendants assert that thimerosal is merely an ingredient designed to maintain the safety, purity and potency of vaccines. Since thimerosal is intended to prevent bacterial contamination, defendants argue, it cannot be considered a contaminant.
Judicial decisions have failed to completely resolve the issue, although the majority of courts that have examined the question have determined that thimerosal is a proper vaccine component and not a contaminant. See, for example, Wax v. Aventis Pasteur Inc., 2002 WL 31444878 (E.D.N.Y. Oct. 30, 2002) (deferring to opinion of secretary of Health and Human Services that thimerosal is not an adulterant or contaminant); Bertrand v. Aventis Pasteur Labs. Inc., 2002 WL 31194226 (D. Ariz. Sept. 23, 2002) (noting that weight of authority supports argument that thimerosal is not contaminant); Liu v. Aventis Pasteur Inc., 219 F.Supp.2d 762 (W.D. Tex. 2002) (finding that thimerosal-related claims first must be submitted to Court of Federal Claims); Strauss v. American Home Prods. Corp., 208 F.Supp.2d 711 (S.D. Tex. 2002); Owens ex rel. Schafer v. American Home Prods. Corp., 203 F.Supp.2d 748 (S.D. Tex. 2002).
Any uncertainty was resolved on Nov. 25, 2002, when President Bush signed the Homeland Security Act. In addition to reshaping the face of the federal government, the act amends the definition of "vaccine" found in the National Childhood Vaccine Act.
The act explicitly defines a "vaccine" to include "all components and ingredients listed in the vaccine's product license application and product label." HR5005, Section 1716. Under this amended definition, thimerosal is now clearly part of a "vaccine" because it commonly is listed on a vaccine's license application and label.
In addition, the new law, which is retroactive, specifically states that "an adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label." HR5005 Section 1715. This provision puts an end to the tenuous argument that a properly listed ingredient can be considered a contaminant.
Although thimerosal is not expressly named in the act, the Congressional record indicates that the vaccine-related provisions were aimed at shielding thimerosal manufacturers from potential tort liability. See 147 Cong. Rec. S11,365 (daily ed., Nov. 19, 2002) (statement of Sen. Phil Gramm).
The practical effect of the new changes is that plaintiffs must submit all pending and future thimerosal-related claims first to the Court of Federal Claims. Future thimerosal-related tort suits will be directed first to the program, while pending actions will be stayed or bifurcated while plaintiffs exhaust their federal remedies.
Although no one knows for certain how many thimerosal-related cases are pending around the nation, approximately 875 already are before the Court of Federal Claims. Anticipating a rise in this caseload, the court has adopted special procedures applicable to thimerosal. The effect will be a shifting of thimerosal claims away from courts and into the program, ending attempts to thwart the federal scheme.
Beyond thimerosal, however, the implications of the amendments are potentially far-reaching. The broad definition of "vaccine" - all components and ingredients listed on the product license application and product label - implicates numerous other substances and makes avoiding the program nearly impossible.
Presumably, the program now governs every component listed on a vaccine's license application and label. This encompasses a wide range of suspensions designed to preserve shelf-life or enhance the body's immune response. Since manufacturers already properly disclose these ingredients, virtually every future vaccine-related injury claim will be subject to the program.
Critics have charged that the amendments are a blatant attempt to protect a powerful industry and an example of the unrestrained power of special interests. Recent signals from Congress indicate a movement to repeal the provisions potentially could be successful.
But most believe that the new law merely directs many vaccine-related claims to a forum where they already belong. By clarifying a definition and codifying a judicial trend, the law prevents creative attempts to circumvent congressional intent. Whatever the result of the political debate, the plain language of the act remains prevailing law.
In creating the program, Congress balanced the desire to swiftly compensate those afflicted with vaccine injuries against the need for sustained research and production. The program provides a largely successful alternative to the traditional tort system, quickly compensating injured children while preserving the incentive to develop life-saving vaccines.
Now, the passage of the Homeland Security Act has resolved any ambiguity about the scope of the program. The new law directs almost all claims for vaccine-related injuries first to the Court of Federal Claims, preventing circumvention of the program.