# Presentation: 130787

**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_:
- National Vaccine Injury Compensation Program (VICP)
- 	•	claims filed in U.S. Court of Federal Claims
- 	•	special masters
- 	•	governed by Vaccine Act
- State and Federal Courts: independent civil actions
- 	•	law of jurisdiction generally applies

## 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

**Notes:**
DERIVITIVE CLAIMS:
(e.g., loss of consortium claim for parent of injured child)

## 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 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 3rd party) derivative claims

**Notes:**
RECENT TREND:

12/02: 190+ thimerosal-related civil actions filed in state & Federal courts (12 putative class actions)

For simplicity, refer to injury as autism, but actually broader range of neurodevelopmental disorders, often referred to as autism spectrum disorder
Note: 2 different theories of causation
	- that thimerosal in covered vaccines caused injuries
	- that MMR vaccine (which never contained thimerosal) caused injuries
	- bulk of litigation appears to be focusing on thimerosal, focus of this discussion

## 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

**Notes:**
PLAINTIFFS’ THEORY:
Claims filed against vaccine manufacturers, distributors & administrators

## 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

**Notes:**
DERIVITIVE CLAIMS:
Some allow such claims to proceed (no award for such harm available in VICP)
– Some not allowed to proceed until underlying VICP claims resolved

GENERAL:
2-tiered process going on at same time: Ct decisions & Fedl legislation: I’m going through all Ct decisions first, then legislation for ease of understanding

## 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_:
- general causation issues: can vaccines cause autism (&, if so, in what circumstances)
- conclusions reached applied to individual cases

**Notes:**
OPT IN:
- as of yet, almost all have opted in 
- may be some that are proceeding based on particular injuries/ diff vaccines

STEP 2:
-(i.e., did vaccines cause injury in this case)

## 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 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”_: h_[ttp://www.uscfc.uscourts.gov/osmautism.htm](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

**Notes:**
Relied heavily on decision of TX district court

SM:
“by any ordinary meaning, a preservative is the antithesis of contaminant because a preserving agent actually prevents the impurity or corruption of the vaccine.”

– “Vaccine manufacturers intentionally add thimerosal to vaccine formulas because it deters microbial and fungal growth, thereby maintaining the safety, purity, and potency of vaccines...." 

Reading adulterant/contaminant to exclude preservatives would undermine purposes, lead to litigation & expose manufacturers & administrators to “the same litigation the Act was designed to reduce or eliminate”

## 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

**Notes:**
SCIENTIFIC COMMUNITY:

- FDA recognizes preservatives are constituent part of vaccines
– thimerosal has FDA-approved role as vaccine preservative
– FDA has not ordered recall of thimerosal-containing vaccines or revoked/suspended approved licenses for such vaccines

- IOM report: insufficient evidence "to accept or reject" causal relationship between thimerosal and autism

## 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)

**Notes:**
GENERAL DISCOVERY:

Vaccine Act: no discovery unless required by special master

Rules: No discovery as matter of right, informal discovery preferred

END:
Special Master Hastings issues monthly status updates

## 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

**Notes:**
“Improved Vaccine Affordability & Availability Act”
Many other sections aimed at improving operation of VICP

## 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

**Notes:**
INCLUDED:
These provisions were included in the Frist bill & included in HSA shortly before bills passed

## 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

**Notes:**
(END) RESULT:
All claims against manufacturer of thimerosal must proceed through VICP initially

## 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

## 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

**Notes:**
END:
HHS Position: clarification of preexisting scheme (even though previously no 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

**Notes:**
END:
(publicity of possible repeal by Congress in early 2003)

## 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

**Notes:**
POTENTIAL:
-Although bulk of caselaw within & outside of VICP states that thimerosal is not a vaccine adulterant/contaminant, if such clarifications removed from law, ongoing litigation possible
impact of “rule of construction” unclear:
Simple states no inference should be drawn prior law incorrect; arguments could be made both that prior caselaw resolved issue & that it was still open 
(VICP caselaw may be persuasive, but not binding on State or Federal courts)

END:
Substantive judicial resolution as to whether thimerosal in covered vaccines or MMR causes neurodevelopmental disorders (such as autism) will likely not occur for some time