1. Thimerosal/Autism Litigation Recent Trends, Decisions & Legislation Presented by Emily Marcus Levine, J.D. Office of the General Counsel U.S. Department of Health & Human Services

2. Statutory Background Two Forums to File Vaccine-Related Injury/Death Claims: 1.National Vaccine Injury Compensation Program (VICP) claims filed in U.S. Court of Federal Claims special masters governed by Vaccine Act 2.State and Federal Courts: independent civil actions law of jurisdiction generally applies

3. Statutory Background Vaccine Act: VICP Generally First Forum almost all vaccine-related injury/death claims must be pursued through VICP as initial matter Exceptions: claims where injury associated with adulterant to/ contaminant of vaccine vaccines not covered by VICP claims for damages of $1,000 or less claims seeking equitable relief claims against manufacturers of components of vaccines derivative claims: claims for harm to non-injured person

4. Statutory Background Opt Out Rights: even in claims that need to pursued through VICP initially, petitioners can pursue later civil action by opting out: –rejecting VICP judgment; or –withdrawing from VICP if special master fails to make decision on petition within 240 days; or –withdrawing from VICP if Court fails to enter judgment on petition within 420 days (limited extensions)

5. Recent Trend: Civil Litigation past: almost all vaccine-related injury/death claims filed initially with VICP recent trend: civil actions alleging autism as result of thimerosal-containing vaccines/ MMR filed without proceeding through VICP first Claims: claims on behalf of autistic children claims on behalf of children w/o injuries for medical monitoring costs parent (or 3 rd party) derivative claims

6. Recent Trend: Civil Litigation Plaintiffs’ theory: exceptions to VICP filing fulfilled –thimerosal = adulterant to/ contaminant of vaccines –less than $1,000 (purported class actions) –equitable relief (medical monitoring) –derivative claims (e.g., loss of consortium) –claims against thimerosal manufacturer & distributors HHS Position: –claims alleging thimerosal as cause of injuries not exempt: must be pursued initially through VICP as vaccine-related injuries –claims against thimerosal manufacturer exempted

7. Recent Trend: Civil Litigation Court Decisions: most courts who have reached issue have held that thimerosal is not vaccine adulterant/contaminant: must proceed first through VICP different decisions as to whether derivative civil actions can proceed other means available to pursue civil actions

8. VICP Litigation: Autism General Order #1 Chief Special Master Golkiewicz; issued 7/30/02 committee: special masters, petitioners’ counsel (Steering Committee) & Government representatives “Omnibus Autism Proceeding”: created by CSM general framework to be applied to claims alleging autism caused by thimerosal-containing vaccines/ MMR petitioners can opt in or opt out 2-step procedure: 1.general causation issues: can vaccines cause autism (&, if so, in what circumstances) 2.conclusions reached applied to individual cases

9. VICP Litigation: Autism General Order #1 “short-form petitions” authorized by CSM: must allege autism injury caused by thimerosal-containing vaccines/MMR (or combination) request compensation from VICP not have pending civil action for same injury or previous award/settlement for same injury other jurisdictional issues satisfied (e.g., statute of limitations)

10. VICP Litigation: Autism General Order #1 “Short form petitions” need not include medical records HHS argued Act requires petitioners to submit records (or affidavit); should be submitted as soon as possible to evaluate statute of limitations and begin medical review special master reached different conclusion Schedule Adopted: discovery to be completed by 8/22/2003 omnibus evidentiary hearing w/experts: 3/22/2004 decision on causation issues: 7/3/2004 Special Master Hastings designated to preside over Omnibus autism Proceeding & rule on general causation issues “Autism Master File”: http://www.uscfc.uscourts.gov/osmautism.htmttp://www.uscfc.uscourts.gov/osmautism.htm

11. VICP Litigation: Leroy v. HHS, 02-392V Special Master Hastings: Decision 10/11/2002 petitioner argued all claims alleging thimerosal-related injuries beyond CFC’s jurisdiction: (preservative = adulterant/contaminant) Special Master: jurisdiction proper: cases must be filed initially in VICP thimerosal not “adulterant" or “contaminant" within plain meaning of Vaccine Act: –because injuries allegedly linked to vaccine ingredient, injuries clearly vaccine-related subject to VICP

12. VICP Litigation: Leroy v. HHS, 02-392V Vaccine Act contemplates streamlined litigation & proceeding through VICP first legislative history supports same conclusion –Vaccine Act's purpose to ensure vaccine safety & supply and reduce civil litigation, while providing compensation to injured vaccinees evidence from scientific community: strong support for considering thimerosal a vaccine component/ constituent

13. VICP Litigation: discovery unusual in VICP cases discovery underway in omnibus proceedings: interrogatories and requests for production pending DOJ working with components of HHS: –OGC, VICP, FDA, NIH, CDC –some documents already provided –identifying, assembling, reviewing documents, considering privileges –working with petitioners’ counsel on difficult issues (e.g., production of materials relating to ongoing/ proposed studies)

14. Legislation Introduced: Frist Bill: last Congress: S. Bill 2053; many proposals designed to improve VICP several sections would have affected thimerosal litigation Examples: extending Vaccine Act to claims for equitable relief removing $1,000 requirement prohibiting awards in civil actions for medical monitoring claims (requiring proof of physical injury) other examples addressed in HSA discussion not enacted

15. Homeland Security Act of 2002 (HSA) enacted November 25, 2002 several provisions affecting thimerosal-related claims & VICP 1 change in existing law (manufacturer of vaccine component) remaining changes: mere clarifications of existing law consistent with HHS’ position

16. HSA: Clarification of Definition of Manufacturer Previous Law covered manufacturers of vaccines on Table not manufacturers of components/ingredients in vaccines HSA extended definition to include manufacturers of any component/ingredient of vaccines on Table “any corporation... which manufactures, imports, processes, or distributes any vaccine set forth in the Vaccine Injury Table, including any component or ingredient of any such vaccine...” extended Vaccine Act to claims against manufacturers of thimerosal for vaccine-related claims change in preexisting law

17. HSA: Clarification of Definition of Vaccine-Related Injury or Death Previous Law excluded from definition of “vaccine-related injury or death” any injury/ death associated with an adulterant/ contaminant intentionally added to vaccine HHS position: thimerosal not such an adulterant/ contaminant HSA clarified definition of “vaccine-related injury or death” “adulterants” or “contaminants” do not include any component/ ingredient listed in vaccine’s product license application and product label thimerosal not an adulterant to/ contaminant of vaccines

18. HSA: Clarification of Definition of Vaccine Previous Law no definition of “vaccine” HSA provides definition of “vaccine” under Vaccine Act “any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body’s immune response to a disease or diseases and includes all components and ingredients listed in the vaccine’s product license application and product label” preservatives listed in license/label included in definition

19. HSA: Effective Date of Vaccine Act Provisions amendments applied to all pending civil actions (on or after 11/25/2002) unless judgment entered “all actions or proceedings pending on or after the date of enactment of this Act, unless a court of competent jurisdiction has entered judgment (regardless of whether the time for appeal has expired) in such action or proceeding disposing of the entire action or proceeding.” some civil actions still not covered by Vaccine Act: –Claims for less than $1,000 in damages –Derivative claims –Unclear: claims asserting equitable relief/ seeking medical monitoring despite repeal, no evidence civil actions dismissed

20. Likely Repeal of HSA Provisions inclusion of such amendments in HSA controversial Congress likely to repeal such amendments Bill Text: non-prejudicial repeal of vaccine-liability sections in HSA Vaccine Act should be applied & administered as if repealed sections had never been enacted Rule of Construction: –no inference shall be drawn from enactment of vaccine liability sections of HSA or from repeal regarding law prior to enactment of HSA –no inference shall be drawn that repeal effects any change in prior law, or that Leroy v. HHS, 02-392V (Oct. 11, 2002) was incorrectly decided

21. Impact of Likely Repeal possible outcome of repeal: –potential for ongoing civil litigation as to whether thimerosal a vaccine adulterant contaminant In civil actions; unlikely within VICP –unclear disposition of pending/future civil actions –claims against manufacturer of thimerosal will not have to be pursued in VICP possible liability provisions included in HSA will be reintroduced into more comprehensive bill affecting operation of VICP