December 9, 2002

The Honorable John D. Ashcroft
Attorney General of the United States
U.S. Department of Justice
10^th and Constitution Avenue, N.W.
Washington, D.C. 20530

The Honorable Tommy G. Thompson
Secretary of Health and Human Services
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear General Ashcroft and Secretary Thompson:

We are writing to express our concern with your recent decision to seek a protective order sealing all information produced by the Department of Health and Human Services (HHS) in the Omnibus Autism Proceeding before the U.S. Court of Federal Claims Office of Special Masters, or “vaccine court.”  The Omnibus Autism Proceeding will now deal with the claims of many children who may have suffered mercury poisoning from the vaccine preservative thimerosal. The timing, scope and justification of this troubling action that will throw a cloak of secrecy over government information that many American families would like to see, raise serious questions, to which we would appreciate your prompt responses.

Specifically, the Administration’s motion seeking the protective order was filed on November 19, 2002, the same day as final passage by the Senate of the Homeland Security bill, P.L. 107-196, containing the provisions requiring that pending and future civil suits on behalf of children allegedly suffering from thimerosal-induced autism be terminated, and transferred to and litigated first in the vaccine court.  This provision added by the Republican leadership in both Houses of Congress, with the concurrence of the White House, proved so controversial that on the days before final passage of the new law and the filing of the protective order, the Republican Leader of the Senate assured the American people that these provisions would be revised when Congress returns next year. 

The scope of the protective order sought is extraordinarily broad and would cloak in secrecy all oral, e-mails, transcripts, graphic matter or other written or electronically stored information provided by HHS, either in the past or in the future, in connection with the Omnibus Autism Proceeding, which has been pending for almost one year.  

Moreover, the protective order sought by the Administration would limit access to government information to the lawyers and experts in the case, and would not allow the children or their families to see the relevant information produced by HHS.  The Administration’s motion for a protective order makes clear that the Administration does not want to allow the children seeking damages to be able to use information discovered from HHS in any civil suits against pharmaceutical companies where the federal agency is not a party.  More bluntly, the Administration states that HHS “will not voluntarily produce discovery material” unless the protective order is entered. 

In the face of press reports that these children and their families already feel “betrayed” that the Administration would “protect the industry at the expense of our children,” Washington Post, Dec. 9, 2002, p. A03, the blanket protective order the Administration now seeks for all information held by the government relevant to their claims has the troubling appearance of shielding pharmaceutical companies from potentially damaging information.  

Please provide prompt responses to the following questions.

1.      Since the Omnibus Autism Proceeding has been pending for almost one year without a protective order in place, please explain the reason for seeking such a protective order on November 19, 2002?

2.      If the Administration’s protective order is granted, all documents or other information produced or disclosed by HHS in the Omnibus Autism Proceeding in response to a discovery demand will be required to be kept secret “indefinitely, without regard to the conclusion of the Omnibus Autism Proceeding.”

(a)    Please explain why the protective order sought by the Administration seeks to keep this information secret forever?

(b)   Please describe what information, if any, will be disclosed at a future date and how the relevant parties, including Congress, will participate in this decision?

(c)    What is the range of penalties that may be ordered by the Court for violation of the protective order should it be adopted?

3.      The protective order sought by the Administration severely restricts access to any information provided by HHS to only the Court, counsel of record and other “qualified persons,” as defined in the Order.  The children allegedly suffering from thimerosal-induced autism and their families are not among the persons whom the Administration would allow to see the HHS information. Please explain why the Administration does not want to allow the children allegedly suffering from thimerosal-induced autism and their families to see relevant information from HHS?

4.      The scope of the protective order sought by the Administration is very broad and         would cover information that may otherwise be subject to release pursuant to the         Freedom of Information Act (FOIA). 

(a)    Please specify which information requested by petitioners would be covered by the proposed protective order and not by the FOIA.

(b)   If the petitioners file FOIA requests for all of the information requested from HHS in the context of the Omnibus Autism Proceeding, what would be the response to the FOIA request from HHS and the Department of Justice?

(c)    Since the proposed protective order does not apply to HHS information “otherwise in the public domain,” is the FOIA the only available avenue to make information held by HHS relevant to the themerosal claims accessible to the children, their families and the public?

5. Please provide the number, filing date, and status of claims currently before the vaccine court.
    
6. How many themerosal claims will be forced into to proceed in the Omnibus Autism proceedings due to Homeland Security Act that would be subject to the protective order?
    
7. Please describe any federal research that has been completed or is underway on the links between thimerosal and autism that may be relevant to these claims, and whether the results of that research would be subject to the protective order sought by the Administration.
    
8. The protective order sought by the Administration would apply to information provided by HHS either in the past or in the future.

(a)    What information has HHS provided in the past to the Omnibus Autism Proceeding that would suddenly be subject to the protective order and shielded from public review? 

(b) To the extent that HHS has already produced information to the               Omnibus Autism Proceeding that has been shared with the children                allegedly suffering from thimerosal-induced autism and their families,                what would be the penalty for those children or their families violating                the protective order should it be adopted by the court?

         (c) What information, if any, has HHS provided in the past in any of the civil       suits filed by children allegedly suffering from thimerosal-induced autism and their families, which suits will now be transferred to the Omnibus Autism Proceeding?

         (d) To the extent that the HHS has provided in the past information in any of the civil suits filed by children allegedly suffering from thimerosal-induced autism and their families, will that information be subject to the protective order should that order be entered by the court?

Your prompt responses to these questions is imperative since this information may be pertinent to the consideration by the Congress of significant changes to, or repeal of, the Homeland Security Act thimerosal-related provisions. 

Sincerely,

____________________        ____________________        ____________________

PATRICK J. LEAHY              HERB KOHL                          DEBBIE STABENOW

Chairman                                  United States Senator               United States Senator