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
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
Statutory BackgroundVaccine Act: VICP Generally First Forum• almost all vaccine-related injury/death claims must be
pursued through VICP as initial matterExceptions:• 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
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)
Recent Trend: Civil Litigationpast: almost all vaccine-related injury/death claims filedinitially with VICPrecent trend: civil actions alleging autism as result of thimerosal-containing vaccines/ MMR filed without proceeding through VICP firstClaims:• claims on behalf of autistic children • claims on behalf of children w/o injuries for medical
monitoring costs• parent (or 3rd party) derivative claims
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
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
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 out2-step procedure:1. general causation issues: can vaccines cause autism (&, if
so, in what circumstances)2. conclusions reached applied to individual cases
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)
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 conclusionSchedule Adopted:• discovery to be completed by 8/22/2003• omnibus evidentiary hearing w/experts: 3/22/2004• decision on causation issues: 7/3/2004Special Master Hastings designated to preside over Omnibus autism
Proceeding & rule on general causation issues“Autism Master File”: http://www.uscfc.uscourts.gov/osmautism.htm
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
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
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)
Legislation Introduced: Frist Bill:
• last Congress: S. Bill 2053; many proposals designed to improve VICP
• several sections would have affected thimerosal litigationExamples:
• 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
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
HSA: Clarification of Definition of Manufacturer
Previous Law• covered manufacturers of vaccines on Table • not manufacturers of components/ingredients in vaccinesHSA• 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
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/ contaminantHSA 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
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
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
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
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