The Public Policy

Vaccine Preemption

A Georgia supreme court ruling could undermine the administration's swine flu program.

By 10.12.09

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Do you plan to be vaccinated for the swine flu? If you have a bad reaction can you sue the vaccine manufacturer? If you live in Georgia, you will be able to file suit, but not if you live in New York, among other places.

Last week, the first doses of swine flu vaccine began to be arrive at hospitals, doctor's offices, and clinics. A short time ago, HHS Secretary Kathleen Sebelius announced that the government has ordered 195 million doses. One might think that, as Yahoo News explained, "Getting licensing from the FDA means that the vaccine is made properly and meets specific manufacturing and quality standards" and that the government "will keep a sharp eye for any very rare side effects."

Getting the response to swine flu right is a big deal for the Obama Administration. It did not want an outbreak to start before the vaccines were ready, and it does not want the vaccine to cause seriously harmful side effects, even in a small number of those who receive it. Those goals are typical of any administration facing a possible epidemic. The Obama Administration is in a box of its own, however, and the Georgia Supreme Court has put it there. In American Home Products v. Ferrari (2007), the Georgia Supreme Court held that the applicable federal law, the National Childhood Vaccine Act of 1986, does not block state court lawsuits claiming that the defective design of a vaccine caused injurious side effects. Such lawsuits, which can arise from the use of any vaccine, threaten the vaccine program. The Administration can either follow its apparent inclination to let lawsuits like the one in Georgia proceed, or it can protect the vaccine program as Congress tried to do in 1986.

The Obama Administration is in a box because, in a May 20, 2009 Memorandum, the President declared that the general policy of his administration with respect to the preemption of state court lawsuits by federal law would be to follow the expressed will of Congress. The President instructed the federal agencies not to conclude that state-law claims were preempted by implication unless Congress so intended. The President also told the federal agencies to review all of the regulations adopted in the last ten years to make sure that the last administration did not sneak in preemptive regulatory provisions that were not consistent with the intent of Congress. In short, the Obama Administration's stated view does not favor preemption.

Almost inevitably, vaccines come with side effects. In the 1980s, the swine flu vaccine then available was blamed for causing the Guillain-Barre paralysis syndrome. It is unclear whether the vaccine, in fact, caused the syndrome, which was rare. More recently, the Court of Federal Claims rejected claims that the measles, mumps, and rubella vaccine and the use of thimerosal as a preservative in various vaccines caused autism and other medical problems. Those findings rested on the consideration of an extensive evidentiary record, including testimony and reports from numerous experts for both sides.

In 1986, Congress enacted the National Childhood Vaccine Injury Act in response to a sharp rise in the number of vaccine-related lawsuits filed against the manufacturers of those vaccines. The costs of defending those lawsuits and the related increases in insurance costs were chasing the manufacturers from the market, causing the price of vaccines to increase markedly and threatening the supply of vaccines. Congress noted that, by the time it was acting, "[T]here [was] only one manufacturer of the polio vaccine, one manufacturer of the measles, mumps, rubella (MMR) vaccine, and two manufacturers of the [diphtheria, pertussis, and tetanus] DPT vaccine."

In the face of this threat, Congress set up a special Vaccine Court to be the first forum to hear complaints of injurious side effects and blocked the state court lawsuits that were chasing vaccine manufacturers from the market. The Vaccine Court, which is part of the Court of Federal Claims, hears claims arising from vaccine-related injuries and deaths. An injured party can be compensated if (1) the vaccine and the injury are addressed in a Vaccine Injury Table, and it cannot be shown that the vaccine did not cause the injury or death; or (2) for non-Table injuries, the injured party shows that the vaccine caused the injury. A claimant who is dissatisfied with the result in the Vaccine Court can appeal or can pursue certain limited claims in state or federal court. In particular, the Act bars state courts from hearing claims for damages if a vaccine-related injury or death "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper warnings and directions."

The Act's bar to state court lawsuits for damages that "resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper warnings and directions" clearly closes the state courts to some lawsuits. In legal terms, that provision is referred to as express preemption. Claims that are not expressly preempted by a federal statute may still be impliedly preempted. Implied conflict preemption arises when it is not possible to satisfy the requirements of both federal and state law or when a state law blocks the realization of the purposes and objectives of Congress. In those cases, the state law is impliedly preempted.

American Home Products v. Ferrari arises from the use of thimerosal as a preservative in vaccines given to the Ferraris' minor son. The Ferraris contend that their son suffered neurological damage from the mercury that is contained in thimerosal. They sued American Home Products claiming that it was negligent in failing to manufacture the vaccine without thimerosal. For its part, the Food and Drug Administration says that thimerosal has been in use since the 1930s and has a "long record of safe and effective use preventing bacterial and fungal contamination of vaccines." After a 1999 review, the FDA found no evidence of harm from the use of thimerosal other than "local hypersensitivity reactions."

The Georgia Supreme Court said that the Act does not bar all claims that a vaccine is defectively designed. Instead, whether a claim is barred depends on a case-by-case determination whether the side effect at issue was unavoidable. The Georgia Supreme Court reasoned first that the language used by Congress was ambiguous in that, by barring claims that result from unavoidable side effects, some side effects must be avoidable. If Congress had wanted to bar all vaccine-related claims, it could have written the statute differently. The court said that, as written, the safe harbor for vaccines that have been "properly prepared and [are] accompanied by proper warnings and directions" does not cover claims that the vaccine has been defectively designed. With respect to the Vaccine Court, the Georgia Supreme Court said that it was not exclusive, but rather that, in creating it, Congress assumed that it would "attract even vaccine-injured persons who may be able to prove that the vaccine was not made as safe as reasonably possible." The Georgia court found that "assumption… certainly questionable to say the least."

The Georgia Supreme Court's treatment of the legislative scheme is breathtaking. More than 20 years after Congress acted to insure a continued supply of vaccines, the court characterizes the imputed intent of Congress as "certainly questionable to say the least." The result of this view is to make the Vaccine Court something less than mandatory and comprehensive. Instead, it will just be a speed bump on the way to the state courts. If design defect claims are not preempted, vaccine injury claims will be packaged that way, not in a way that risks their being barred.

The United States Supreme Court is considering what to do with the Georgia Supreme Court's decision that state courts can hear claims that injuries attributed to side effects of vaccines that are said to be avoidable. Other courts, including the third Circuit Court of Appeals, have reached the opposite conclusion, so Georgia plaintiffs can file suit while New York plaintiffs cannot. Back on June 8, the Court asked the Administration for its views of the case, but the Solicitor General has not responded yet. The Obama Administration can either defend the program or follow its inclination to let state courts decide whether we have one. It cannot do both.

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About the Author
Jack Park is an attorney with the Atlanta law firm Strickland Brockington Lewis LLP.