http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=1808546

US Government Asks Court to Seal Vaccine Records
Tue November 26, 2002 10:47 AM ET
By Todd Zwillich
WASHINGTON (Reuters Health) - Attorneys for the Bush Administration asked a federal court on Monday to order that documents on hundreds of cases of autism allegedly caused by childhood vaccines be kept from the public. Department of Justice lawyers asked a special master in the US Court of Federal Claims to seal the documents, arguing that allowing their automatic disclosure would take away the right of federal agencies to decide when and how the material should be released. Attorneys for the families of hundreds of autistic children charged that the government was trying to keep the information out of civil courts, where juries might be convinced to award large judgments against vaccine manufacturers.

The court is currently hearing approximately 1,000 claims brought by the families of autistic children. The suits charge that the measles-mumps-rubella (MMR) vaccine, which until recently included a mercury-containing preservative known as thimerosal, can cause neurological damage leading to autism.

Federal law requires suits against vaccine makers to go before a special federal "vaccine court" before any civil lawsuit is allowed. The court was set up by Congress to speed compensation claims and to help protect vaccine makers from having to pay large punitive awards decided by juries in state civil courts. Plaintiffs are free to take their cases to state courts if they lose in the federal vaccine court or if they don't accept the court's judgment.

The current 1,000 or so autism cases are unusual for the court. Because it received so many claims, much of the fact-finding and evidence-gathering is going on for all of the cases as a block. Monday's request by the Bush Administration would prevent plaintiffs who later go to civil court from using some relevant evidence generated during the required vaccine court proceedings. Plaintiffs' attorneys said that the order amounted to punishment of the families of injured children because it would require them to incur the time and expense of regenerating evidence for a civil suit. "Wouldn't it be a shame if at the end of the day our policy would be to compensate lawyers," said Jeff Kim, an attorney with Gallagher Boland Meiburger & Brosnan. The firm represents about 400 families of autistic children who received the MMR vaccine.

Kim accused the government of trying to lower "a shroud of secrecy over these documents" in order to protect vaccine manufacturers, who he said were "the only entities" that would benefit if the documents are sealed. While federal law clearly seals most documents generated in individual vaccine cases, it has never been applied to a block proceeding like the one generating evidence in the autism cases.

Administration lawyers told Special Master George Hastings that they requested the seal in order to preserve the legal right of the Secretary of Health and Human Services to decide when vaccine evidence can be released to the public. Justice Department attorney Vincent Matanoski argued that to let plaintiffs use the vaccine court evidence in a later civil suit would confer an advantage on plaintiffs who chose to forgo federal compensation. "There is no secret here. What the petitioners are arguing for are enhanced rights in a subsequent civil action," Matanoski said of the plaintiffs. "They're still going to have unfettered use within the proceedings."

Hastings would not say when he would issue a ruling on whether to seal the court documents, but did say that his decision would be "very prompt."

Law Firms Continue Thimerosal Litigation
WASHINGTON, Nov 26, 2002 (BUSINESS WIRE) --

A consortium of law firms representing children exposed to mercury in vaccines, led by attorneys Michael Williams, of Portland, Oregon, and Richard S. Lewis of Washington, D.C., have vowed to continue litigation against manufacturers of thimerosal, a mercury-based preservative found in some childhood vaccines, despite the "Eli Lilly" rider attached to the Homeland Security Bill and signed into law by President Bush yesterday.

The national consortium, lead by Williams, of Williams, Dailey, O'Leary, Crane & Love, and Lewis with Cohen, Milstein, Hausfeld & Toll, is seeking to have vaccine manufacturers set up court-administered funds that would allow children to get needed medical tests in order to mitigate potential neurological damage caused by thimerosal exposure.

Thimerosal, which is fifty percent mercury, was added to vaccines to prevent bacteria contamination when a doctor repeatedly drew vaccine doses from the same vial. After scientists and parents raised concerns about injecting children with mercury, thimerosal was taken out of vaccines in the late 1990s. Lawyers contend, however, that thimerosal and vaccine manufacturers' documents indicate that these companies knew about the health problems associated with thimerosal since at least the early 1970s. The Institute of Medicine has also concluded it is "biologically plausible" that thimerosal is causing neurodevelopmental disorders. While the rider attached to the Homeland Security Bill forced thimerosal personal injury claims into the Vaccine Injury Compensation Program, a federal program designed to protect vaccine manufacturers from liability and reduce compensation levels for victims, the rider will not have any effect on cases seeking "medical monitoring" injunctive relief which gives medical tests to children, not cash awards. Lawyers contend, however, that it is likely that lobbyists will push for additional special interest legislation in the new session of Congress to wipe out the medical monitoring cases, completely depriving mercury-exposed children of any remedy in the court system and shutting down fact investigation into what the drug companies knew about the dangers of thimerosal and when they knew it.

Richard S. Lewis responded to the Homeland Security Bill signing by stating that, "We are troubled that this provision was made a part of this bill; we will actively continue our efforts to seek testing for kids who were exposed to excessive mercury levels so that we can mitigate brain damage before it becomes irreversible."

Michael Williams added, "The `Eli Lilly' rider merely reinforces the importance and public health necessity of this law suit. The back-room deal that put these anti-child amendments into the Homeland Security Bill is just the first step in the drug companies' efforts to completely avoid any responsibility for what they did to a generation of children."

Other members of the consortium include: Larry Cohan of Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley in Philadelphia, Pennsylvania; Tobias Millrood of Schiffrin & Barroway in Philadelphia, Pennsylvania; and David Klein of Klein and Lyons of Vancouver, British Columbia, Canada.

Copyright (C) 2002 Business Wire. All rights reserved

Senators Vow to Repeal Homeland Security Provision
Wed, 27 Nov 2002 20:48:26 -0500
Sen. Daschle, Rep. Pelosi Vow to Repeal Homeland Security Provision Shielding Drug Makers From Liability
11/27/02

Claims That Congress can 'Fix' the Problem Are Misleading WASHINGTON, Nov 27, 2002 /PRNewswire via COMTEX/ -- Safe Minds and the Mercury Policy Project are hailing a statement by the US House and Senate leadership that they will work to repeal a corporate special-interest provision in the Homeland Security Bill. The provision wipes out all legal remedies for thousands of autistic children harmed by mercury in infant vaccines and must be eliminated, the two groups working to prevent mercury-related injuries said today.

"We strongly support Senate Majority Leader Tom Daschle and House Democratic Leader-Elect Nancy Pelosi's vow to remove egregious special interest provisions, including the thimerosal liability shield for Eli Lilly," said Michael Bender, Director of the Mercury Policy Project. As passed, the Homeland bill allows the families to re-file their claims in a special administrative court for vaccine-related injury cases where it takes years for cases to be heard and 87% of the claims filed are denied. And claims can only be made by parents if their child's first symptom of neurological damage occurred within the last three years, which effectively bars many families from going to court to hold Lilly accountable for their children's injuries, the groups said.

"It is a sad state of affairs when the Congress and the White House conspire to benefit a pharmaceutical giant at the expense of injured children and families whose lives have been shattered by corporate wrongdoing," said Lyn Redwood, RN, president of Safe Minds and the parent of a child who developed multiple disabilities after receiving 125 times the government-recommended exposure to mercury. "Eli Lilly has been allowed to exploit a national threat to America to further their own agenda."

The provision to benefit Lilly -- which was added to the unrelated Homeland Security Bill at the last minute -- affects lawsuits against the drug maker for injuries caused by its product thimerosal, a mercury-based preservative that was used in infant vaccines until a few years ago.

"Claims by Republican congressional leaders that they will "fix" the provision next year are empty promises because it will be too late," said Michael Bender, Director of the Mercury Policy Project. "Once President Bush signs the bill -- which will happen any day -- Eli Lilly can go to court and have all the mercury vaccine-related lawsuits against it dismissed immediately."

According to Redwood, after conversations with senate staff, the "fix" will do little if anything to right this wrong. "Our children have been silenced once by autism and now the votes of Congress have silenced them again," said Redwood. "The right thing to do would be to pass legislation as soon as possible to strike the thimerosal provisions." The lawsuits were filed by the families of children who developed autism, learning disabilities and other neurological problems after multiple mercury exposures. It takes hundreds of thousands of dollars each year to care for a severely autistic child and millions over the victim's lifetime.

A Homeland Security Whodunit

http://www.washingtonpost.com/wp-dyn/articles/A48496-2002Nov27.html
In Massive Bill, Someone Buried a Clause to Benefit Drug Maker Eli Lilly
By Jonathan Weisman
Washington Post Staff Writer
Thursday, November 28, 2002; Page A45

It amounted to only two paragraphs at the end of a 475-page bill to create the Department of Homeland Security. But the brief provision -- designed to shield vaccine makers such as Eli Lilly and Co. from lawsuits seeking billions of dollars for families of autistic children -- has generated a whirlwind of controversy and a mystery as to its origin. The paragraphs appeared just days before the House was to vote on the legislation. House Republicans rammed the bill through during Congress's "lame duck session" and sent it to the Senate, where Democrats, demoralized by the Nov. 5 election results, could not to stop it.

And so, with little debate, Congress granted broad legal protection to the makers of Thimerosal, a preservative in childhood vaccines that has been circumstantially linked to rising rates of autism and pediatric developmental problems. It seemed a lobbying coup for Lilly and its allies. Yet, strange to say in Washington, no one seems to want to take credit. Pharmaceutical lobbyists, Eli Lilly representatives and lawmakers with the most knowledge of the Thimerosal issue have denied any role in the provision's last-minute appearance. Now, White House budget director Mitchell E. Daniels Jr., a former Lilly executive, is the latest person to formally deny a part. He did so in a sharply worded response to an accusatory letter by Rep. Henry A. Waxman (D-Calif.).

Daniels said the provision was not approved or developed by the White House Office of Management and Budget, adding:
"I also want to make clear that I personally had no involvement whatsoever with these provisions. I spoke to no one about these provisions, either inside the administration or outside the administration. . . . I did not have any communications with anyone from Eli Lilly regarding the issue. Indeed, I had not even heard of Thimerosal until I received your letter, which is not surprising because Eli Lilly stopped making Thimerosal a decade before I began working there and the lawsuits appear to have been filed after I left."

Since the provision's appearance, some Democrats and trial lawyers have charged that it represented a timely payback for the pharmaceutical industry's financial support in the midterm elections. "President Bush and conservative Republicans are going to give the pharmaceutical companies whatever they ask for," said Michael Williams, an Oregon lawyer who represents several families of autistic children and believes billions of dollars could be at stake.

Under the provision, a raft of Thimerosal lawsuits will be redirected from state courts to the federal Vaccine Injury Compensation Program, which caps damages and sharply limits who can file suits against vaccine makers. Proponents say the provision merely closes a loophole, which had been exploited by trial lawyers claiming that Thimerosal was a vaccine "contaminant" not subject to existing legal regulations. If action was not taken, advocates say, the lawsuits could have driven vaccine makers out of business.

The provision was drafted more than a year ago by Sen. Bill Frist (R-Tenn.) as part of a broader bill to revise the vaccine program. That bill, which Frist had hoped to begin action on next year, includes measures favoring plaintiffs as well as manufacturers. It would raise the cap on damages, extend the statute of limitations for filing suit and allow the parents of autistic children to sue on their behalf.

An aide to retiring House Majority Leader Richard K. Armey (R-Tex.) said Armey's staff put the Thimerosal provision in with no prodding from the pharmaceutical industry or the White House.

But several corporate lobbyists said that is not credible. Whoever was responsible had to have detailed knowledge of the legal issues, had to know Frist had drafted the larger bill, and had to understand exactly which provision applied to Thimerosal because the brand name does not appear in the text. Two sources said an official at the Department of Health and Human Services gave the final approval, a statement that HHS spokesman Bill Pierce adamantly denied.

What is clear is that as recently as two months ago, lobbyists for Lilly and other drug makers were on Capitol Hill trying to get the entire Frist vaccine bill inserted into the homeland security legislation. But, the lobbyists said, they were as surprised as anyone when the two-paragraph item was included.

One senior Republican Senate aide said a member of Frist's staff received a call just days before the House passed the homeland security bill, saying he had heard a rumor that the Thimerosal provision was included. The Frist aide said the lobbyist was confusing that provision with another measure to protect makers of smallpox vaccines. The next day, the aide said, Frist's staff found the Thimerosal provision in the bill as they scanned it in the Senate cloakroom. "We don't know how it became part of the House bill," said Rob Smith, a Lilly spokesman. "We didn't know it was part of the bill, and it was a surprise to us." The provision could be the lobbying coup of the 107th Congress. A series of ongoing academic studies should be able to conclude within the next three years whether Thimerosal, a mercury-based additive, can be scientifically linked to an upswing in autism, Williams said. Absent the two-paragraph provision, such a conclusion could open the legal floodgates. Yet corporate lobbyists who might be expected to crow about saving their clients potentially billions of dollars have stayed mum. That may be in part because the deed was done rather clumsily, one lobbyist said. The provision was not even hidden. Instead, it was simply tacked on at the end of the bill. That has brought down a wave of unwanted publicity on vaccine makers, especially Lilly, the inventor of Thimerosal.

"They didn't even make an effort to be clever about it," the lobbyist said.