Author of Vaccine Liability Provision in Homeland Security Bill Uncertain

No member of either the Bush administration or Congress has stepped forward to acknowledge having written a provision attached to legislation authorizing a Homeland Security Department that protects Eli Lilly from lawsuits involving a preservative that was used in vaccines, the New York Times reports (Gay Stolberg, New York Times, 11/29). The rider protects vaccine manufacturers from lawsuits filed over allegations that thimerosal, a mercury-based vaccine preservative, causes autism in children. Under the provision, a federal vaccine compensation program established in 1988 to provide liability protection for vaccine manufacturers will address lawsuits related to vaccines. The provision stipulates that vaccine manufacturers may only be sued if a plaintiff is "unhappy" with the remedy offered by the federal program. To ensure passage of the homeland security bill, which was signed last month by President Bush, Republican leaders promised to "revisit" the liability provision in January and amend the exemption so that it does not apply to lawsuits that have already been filed (Kaiser Daily Health Policy Report, 11/26). Eli Lilly lobbyists had pushed for the provision and Sen. Bill Frist (R-Tenn.) earlier had sponsored such a measure, but the bill it was attached to "went nowhere," the Times reports. After that, Lilly lobbied to have the language inserted into the homeland security bill, but the Times reports that lawmakers "rebuffed" the request, and the drug company gave up. Now, there is "speculation" about who is responsible for adding the language into the bill. "It's a mystery to us how it got in there," Rob Smith, a Lilly spokesperson, said. According to congressional aides, the provision was added to the homeland security legislation during negotiations between House and Senate Republican aides over Veterans Day weekend. One aide said the language "mysteriously appeared" in the House version of the bill, as if someone had pasted it in from Frist's failed bill. Richard Diamond, a spokesperson for retiring House Majority Leader Richard Armey (R-Texas), would not say who was responsible for such an action, but added that all those involved in the negotiations supported the move. He said, "If you want to give somebody credit for it, Mr. Armey takes ultimate credit. It's his bill." Diamond added, "We are happy to wrap ourselves around it, but Mr. Armey is not a doctor, like Sen. Frist. He's the source of the language" (New York Times, 11/29).

Sealed Documents
In related news, the Justice Department has asked a federal claims court to seal all documents related to lawsuits alleging a link between thimerosal and autism and other neurological disorders in children. About 1,000 families have filed claims through the federal vaccine compensation program; a special master, George Hastings, is hearing the claims. The Times reports that the request was made on behalf of HHS Secretary Tommy Thompson, whose department administers the compensation program. An HHS spokesperson said the law that created the program gives the secretary the right to control what information is released, adding that the government is attempting to "preserve that right." Lawyers for the families, however, said the government is attempting to keep families from "obtaining damaging information" about thimerosal that could be used in civil cases against drug companies (Gay Stolberg, New York Times, 11/27).