Fifth Circuit allows case against thimerosal maker to proceed.

The National ChildhoodVaccine Injury Act of 1986 does not bar suits against the manufacturer of the vaccine component thimerosal, the Fifth Circuit has ruled. (Moss v. Merck & Co., 381 F.3d 501 (5th Cir. 2004).) Because thimerosal is an additive, the court drew a distinction between its manufacturer, Eli Lilly & Co., and vaccine makers.

"Eli Lilly seeks to be treated on like terms as the vaccine defendants," wrote Judge Jerry Smith. "Because thimerosal is not a vaccine, its producers are not vaccine manufacturers as that term is defined in the Vaccine Act, so they are not entitled to the protections of the act's restriction on the filing of suits."

Thimerosal's "status as a vaccine component no more makes thimerosal a 'vaccine' than does the inclusion of a piston under the hood of an automobile make that object an 'engine,'" Smith wrote.

"This is a landmark decision," said Robert Krakow, a director of the nonprofit group SafeMinds (Sensible Action for Ending Mercury-Induced Neurological Disorders). He noted that Moss marks the first time that a court has allowed a tort suit to proceed against the manufacturer of a component of a vaccine covered by the act. Other courts have blocked these claims. (See Jean Hellwege, Thimerosal Plaintiffs Push On Despite Setbacks, TRIAL, May 2004, at 96.)

Thimerosal is an organic mercury compound used widely in the 1990s as a preservative in vaccines, especially in multidose packages. Use began to decline in 1999, when the FDA-warned that infants who received vaccines containing thimerosal risked exposure to mercury that exceeded federal guidelines. (See Jean Hellwege, Child-Vaccine Preservative Prompts Surge in Mercury-Poisoning Claims, TRIAL, Aug. 2002, at 14.)

Scott and Janice Moss allege that their daughter, Amber, developed autism as a result of receiving vaccines containing mercury. They sued three vaccine manufacturers--Merck & Co.; Aventis Pasteur, Inc.; and Wyeth, Inc.--and Eli Lilly for their loss of consortium with her. Their amended complaint included no claims for Amber's injuries. The defendants obtained a dismissal on the grounds that the Vaccine Act precluded the Mosses' tort suit, but the Fifth Circuit reversed that judgment, finding that Eli Lilly is not a vaccine maker shielded by the act.

The court also reinstated the claims against the vaccine makers, holding that the act does not preempt tort claims by plaintiffs who are not eligible for compensation under the act. Because Scott and Janice Moss did not receive a vaccine, "they are ineligible to file a petition, and the Vaccine Act's restriction on the filing of tort suits does not apply to them," the court held.

Under the Vaccine Act, victims cannot seek redress in the courts unless they have first filed a claim for recovery in the federal Vaccine Court, where they can seek a compensatory award from the government under lower standards of proof. If they accept an award, they waive further tort rights; if they decline it, they may pursue traditional tort relief, with some restrictions.

Although the Fifth Circuit said that nothing in the Vaccine Act prevents a plaintiff from going to court to prove his or her injuries were caused by a vaccine component, it noted that such a case might be difficult to make. "The burden of proof at trial may be complicated by the difficulty inherent in demonstrating that the injury was proximately caused by that singular component, rather than the vaccine itself, but this does not mean the Vaccine Act prevents plaintiffs from trying," Smith wrote.

"The decision is extremely important for more than 4,000 families who have filed lawsuits claiming thimerosal caused injuries to their children, because it allows some lawsuits against Lilly and other thimerosal manufacturers to go forward," Krakow said. Plaintiffs who bring claims in state and federal courts will be permitted to conduct discovery, which they cannot do in the Vaccine Court, he added. The Mosses opted to stay their suit pending the Vaccine Court's decision on an award to Amber.

In May, the National Academy of Sciences' Institute of Medicine (IOM) reaffirmed its 2001 finding that there is insufficient evidence to prove an association between autism and thimerosal. A National Academies press release called the alleged link "theoretical only."

Scott Bickford of New Orleans, the Mosses' attorney, said it is too early to tell how the IOM report will affect litigation. "There are many problems with the report, and its findings will be heavily disputed," he said.