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October 2002
Vol. 38, No. 10

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Washington focus


Grand illusion

Kristin Loiacono

It's been said we shouldn't judge books by their covers. Similarly, U.S. senators shouldn't judge bills by their titles. The concepts suggested by the "short title" of S. 2053, the Improved Vaccine Affordability and Availability Act, seem appealing at first glance.Who could be against better and more widely available vaccines? But a closer reading of the bill's sections reveals a far more sinister goal: to give manufacturers of products that may have caused millions of children to suffer neurological injury a means of evading accountability.

The products in question are vaccines—specifically, those that contain thimerosal, a mercury-laden preservative. For more than 50 years, manufacturers have relied on thimerosal to prevent contamination of vaccines and some over-the-counter products, including cosmetics, antiseptic sprays, and contact lens solutions. Its use in childhood vaccines soared in the early 1990s when, to cut costs, manufacturers began producing more vials containing multiple doses of medication. Single-dose vials need no preservative because they are thrown away once used. But multidose vials, which are tapped repeatedly to innoculate several children, contained thimerosal to inhibit contamination of opened vials.

Known toxin

Some parents of children who suffer from autism and other neurodevelopmental impairments say the mercury in thim erosal is the reason for their children's disorders. Many, on behalf of their children, have filed suit against the manufacturers of thim erosal and the pharmaceutical companies that used it in vaccines. In addition to compensatory damages, the plaintiffs are asking courts to make the defendants pay for medical monitoring of all children who received thimerosal-laced vaccines and for research concerning the possible link between the preservative and neurodevelopmental disorders.

In 1999, the FDA asked manufacturers to stop using thimerosal in childhood vaccines. It is still used in a few others, including the influenza vaccine, which is given annually during flu season to adults and some children. And because there was no recall, some doctors' offices may still have vials of childhood vaccines that contain thimerosal.

Although mercury is recognized as a human toxin—high exposure levels can cause nervous system abnormalities including difficulty with coordination, vision, and learning—no definitive study on the effects of thimerosal on childhood development exists. The National Academy of Sciences Institute of Medicine issued a press release one year ago (Oct. 1, 2001), stating: "No evidence currently exists that proves a link between thimerosal-containing vaccines and autism, attention deficit-hyperactivity disorder, speech or language delays, or other neurodevelopmental disorders. . . . It is medically plausible that some children's risk of a neurodevelopmental disorder could rise in part through increased mercury exposure from thimerosal-containing vaccines."

Forcing manufacturers to fund the necessary research to answer the causation question is one of the plaintiffs' goals. But S. 2053, introduced March 21, 2002, by Sen. Bill Frist (R-Tenn.), would summarily shut down all litigation, leaving parents and children waiting for compensation and answers.

The National Childhood Vaccine Injury Act of 1986 created a no-fault compensation alternative to suing vaccine manufacturers when certain vaccines cause injury or death. Claimants are required to seek compensation through the federal program before pursuing a lawsuit. If a claimant rejects an award or is unsuccessful, a lawsuit may then be filed, but certain restrictions may apply.

Plaintiffs argue the act doesn't apply to thimerosal, because it isn't a vaccine, it's a preservative. By vastly expanding the act's definitions of "vaccine," "vaccine manufacturer," and "vaccine-related injury," S. 2053 would effectively remove thim erosal cases from the traditional products liability tort system. Instead, they would be subject to the federal compensation system and to the act's other provisions.

Moreover, S. 2053 would immediately stop all thimerosal litigation because amend ments made by the bill would "apply to all actions or proceedings pending on or after the date of enactment." Cases in mid-trial would be terminated.

The Frist bill raises serious concerns beyond just the thimerosal cases. For example, under the bill, a parent would no longer be permitted to sue a vaccine manufacturer or administrator for injuries the parent suffered because of a child's vaccine-related injury or death—including damages for loss of consortium and emotional distress—unless that action were joined with one brought by the child.

A future for S. 2053?

S. 2053 has three cosponsors, Senators Jim Bunning (R-Ky.), Kay Bailey Hutchison (R-Tex.), and Gordon Smith (R-Or.). Sen. Frist recently told his colleagues that "new companies that may want to produce vaccines are confronted with the high risk of liability and little profit motive. [This bill] would help compensate those who suffer serious side effects from vaccines while ensuring that unwarranted litigation does not further destabilize our vaccine supply."

There is no question that states need federal assistance to help bolster local vaccine supplies for adults, adolescents, and children. Title I of S. 2053 would address that need. Title II, the vaccine injury compensation title, would only add further injury to families whose children have been harmed by vaccines.

 


Kristin Loiacono is ATLA's associate director for media outreach and coalition development in the Media Relations Department.

Balancing the Scales of Justice
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