In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS (E-Filed: March 12, 2010) No. 03-215V TO BE PUBLISHED ____________________________________ GEORGE and VICTORIA ) MEAD, Parents of ) Omnibus Autism Proceeding; WILLIAM P. MEAD, ) Test Case; Petitioners’ Second ) Theory of General Causation; Petitioners, ) Failure to Prove that ) Thimerosal-Containing v. ) Vaccines Cause Autism ) SECRETARY OF HEALTH AND ) HUMAN SERVICES, ) ) Respondent. ) ____________________________________) Thomas Powers, Portland, OR, for petitioners. Lynn Ricciardella, United States Department of Justice, Washington, DC, for respondent. DECISION1 1 Vaccine Rule 18(b) provides that all of the decisions of the special masters will be made available to the public unless an issued decision contains trade secrets or commercial or financial information that is privileged or confidential, or the decision contains medical or similar information the disclosure of which clearly would constitute an unwarranted invasion of privacy. When a special master issues a decision or substantive order, the parties have 14 days within which to move for the redaction of privileged or confidential information before the document’s public disclosure. In this case, petitioners have elected to waive the 14-day period afforded for redaction requests prior to the public disclosure of an issued decision. In Petitioners’ Notice to Waive the 14-Day Waiting Period as Defined in Vaccine Rule 18(b) (Petitioners’ Waiver Notice), petitioners state that “none of the information they have furnished in their case is ‘private’ information.” Petitioners’ Waiver Notice at 1, filed on 1/26/10. Petitioners add that the “disclosure of any or all information they have furnished (continued...) CAMPBELL-SMITH, Special Master On January 29, 2003, George and Victoria Mead (petitioners or the Meads), as parents of William P. Mead (William), filed a short-form petition2 pursuant to the National Vaccine Injury Compensation Program3 (the Act or the Program), 42 U.S.C. § 300aa-10, et seq. With the consent of the Meads, the Petitioners’ Steering Committee 1(...continued) would not be an invasion of William Mead’s privacy.” Id. Noting further that there is significant public interest in the OAP proceedings, petitioners recognize the likelihood “that the public will seek immediate access to the details” of the issued decision. Id. In consideration of the public interest in details of the issued decision and because the furnished information is not private, petitioners have waived the right to seek a redaction of the decision. Respondent also has elected to waive the right, afforded under the Vaccine Rules, to seek a redaction of the issued decision. See Respondent’s Consent to Disclosure at 1, filed on 1/13/10. 2 As permitted by the Order dated July 8, 2002, petitioners electing to participate in the Omnibus Autism Proceeding (OAP) were permitted to file a short-form “opt-in” petition. See OAP Order of 7/8/02 at 1, 4. Each short form petition would consist of the name of the injured child, the names of the injured child’s parents or legal representatives, and an election to opt into the OAP proceeding. Id. at 1. The petition “would not contain a detailed account of the relevant vaccinations and the vaccinee’s disorder.” Id. Nor would the vaccinee’s medical records be required to accompany the petition. Id. Prior to filing their vaccine claim here, the Meads had filed a civil lawsuit in Oregon state court against a number of pharmaceutical companies alleging that the thimerosal additive in many pediatric vaccines significantly contributed to the development of William’s autism. See Petitioners’ Post-Hearing Brief (Mead Ps’ Brief) at 6. The state court determined that the Meads’ thimerosal injury claim was “vaccine- related” as defined under the Vaccine Act, see 42 U.S.C. § 300aa-33(5), and thus, the Meads could not maintain their civil action against the vaccine manufacturers without first seeking a remedy under the National Vaccine Injury Compensation Program. See King v. Aventis Pasteur, Nos. 0201-00126 and 0106-05780, 2003 WL 23531954 (Or. Cir. Mar. 20, 2003) (Stipulation and Order of Dismissal). Accordingly, the state court claim was dismissed to permit the Meads to pursue this claim now before the Office of Special Masters. See id. 3 Hereafter, for ease of reference, all “section” references to the Vaccine Injury Compensation Act will be to the pertinent subsection of 42 U.S.C. § 300aa (2006). 2 (PSC) designated this case on November 19, 2007, as one of the three test cases to be heard in the Omnibus Autism Proceeding (OAP) on petitioners’ second theory of general causation.4 See Docket of Omnibus Autism Proceeding (OAP Docket),5 Order Modifying Schedule for PSC’s “Second Theory” of Causation, dated November 20, 2007, at 2. The three test cases designated by the PSC for petitioners’ second theory of causation proceeded “on the theory that thimerosal as contained in certain pediatric vaccines was a substantial contributing cause of neurodevelopmental injuries, including autism spectrum disorder, in certain claimants in this proceeding.” See Docket of Autism Omnibus Proceeding (OAP Docket), PSC Proposal for Scheduling Additional Test Cases, dated June 25, 2007, at 1. For the reasons discussed more fully in this decision,6 the undersigned finds that petitioners are not entitled to Program compensation on either the proposed general theory of causation or the specific theory of causation proposed in William Mead’s case. I. Procedural Background This case is one of three test cases heard in the OAP addressing the second general causation theory advanced by petitioners. A brief description of the OAP follows. 4 The Meads’ willingness to present their case as a test case in the OAP litigation is very much appreciated. 5 For complete information concerning the autism proceedings including audio files and transcripts of the hearings on causation, see http://www.uscfc.uscourts.gov/omnibus-autism-proceeding (last visited 3/9/10). The OAP Docket, which includes orders, decisions, and periodic updates issued by the special masters assigned to the autism docket, is available at http://www.uscfc.uscourts.gov/node/2718. Filings by petitioners and respondent are posted on this website. 6 For ease of reference to the various sections of this decision, the undersigned has attached an outline of the opinion at the conclusion of the decision as an appendix. 3 A. The Omnibus Autism Proceeding7 Vaccine Rule 3(b) tasks a special master with responsibility “for conducting all proceedings, including taking such evidence as may be appropriate, making the requisite findings of fact and conclusions of law, preparing a decision, and determining the amount of compensation, if any, to be awarded.” Rules of the Court of Federal Claims (RCFC), Appendix (App.) B, Vaccine Rule 3(b)(1). Vaccine Rule 8(a) permits a special master, after consultation wit the parties, to “determine the format for taking evidence and hearing argument” in a proceeding. RCFC, App. B, Vaccine Rule 8(a). Additionally, the Vaccine Rules counsel that when determining how to conduct vaccine proceedings, a special master shall “endeavor[] to make the proceedings expeditious, flexible, and less adversarial, while at the same time affording each party a full and fair opportunity to present its case and creating a record sufficient to allow review of the special master’s decision.” RCFC, App. B, Vaccine Rule 3(b)(2). Consistent with the duties of a special master, set forth in Vaccine Rule 3(b), for determining how to conduct Program proceedings most efficiently, the Chief Special Master issued Autism General Order #1 on July 3, 2002, outlining the procedure for handling the anticipated filing of approximately 3,000 to 5,000 petitions alleging that certain administered childhood vaccines were causing the neurodevelopmental disorder of autism or autism spectrum disorder in children. See OAP Docket, Autism General Order #1 at 1-2. The coordinated proceedings addressing the numerous filed petitions seeking compensation for the alleged vaccine-related autistic disorders are referred to as the Omnibus Autism Proceeding (OAP). The underlying purpose of the OAP has been, and continues to be, to resolve the numerous filed petitions as expeditiously as possible. The procedure adopted for addressing the filed claims resulted from a number of meetings between the Chief Special Master and an informal advisory committee comprised of various petitioners’ counsel and legal and medical representatives of the Secretary of the Department of Health and Human Services. The claims involved in the OAP were assigned initially to a single special master, Special Master George Hastings, for consideration. The adopted procedure for addressing the OAP claims anticipated the conduct of a two-phase proceeding. OAP Docket, Autism General Order #1 at 3. The first phase of the proceeding would inquire into the general causation question of whether certain vaccinations could cause autism and, if so, under what circumstances. Id. at 3-4. The second phase of the proceeding would involve applying the information acquired during the first phase of the proceeding 7 For complete information concerning the autism proceedings, see http://www.uscfc.uscourts.gov/omnibus-autism-proceeding. 4 to decide the specific causation question of whether the received vaccinations did cause the autistic condition alleged in each individual case. Id. at 4. At the request of petitioners’ counsel, through the designated PSC (Petitioners’ Steering Committee), petitioners were afforded a generous period of time to conduct discovery that would inform their theories concerning causation. During the afforded period of time, the PSC sought documents from various federal agencies, including the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the Agency for Toxic Substances and Disease Registry (ATSDR). See OAP Docket, Ruling Concerning Motion for Discovery from Merck re MMR Vaccine, dated July 16, 2004, at 4. Numerous documents that were responsive to the PSC’s discovery request were obtained and were filed into the case of Taylor v.