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