Top Priority!!! Phone, fax, and/or email your Senators IMMEDIATELY to
state your fervent opposition to Senate Bill 2053 (the "Frist Bill"). This
bill may be voted on as early as Wednesday, July 31st.
If Senate Bill 2053 passes, it will prevent parents from suing the drug
companies for the harm--INCLUDING AUTISM--caused by poorly manufactured and
poorly tested vaccines. Juries, not politicians, should decide whether the
families are entitled to compensation from the drug companies.
See web site: www.stopfristbill.org for more information.
Bernard Rimland, Ph.D.
Autism Research Institute
Vaccine Injury Alliance -- Analysis
S 2053 By the Numbers...
Senator Bill Frist (R-TN) has introduced the "Improved Vaccine Affordability
and Availability Act" or S 2053, to amend the National Vaccine Injury
Compensation Program ("Program"). While undoing every gain that petitioners'
families have made over the past several years, S 2053 also represents an
attack on the very spirit of the Vaccine Program as it sacrifices the best
interests of our children for the sake of protecting the vaccine
manufacturers. Unlike its counterpart bill in the House of Representatives,
HR 3741, the Frist amendment in the Senate does little if anything to
protect or defend, let alone extend the rights of children in this country
who have been injured by their recommended childhood vaccinations. Rather,
it is determined, almost cynical, in its apparent disregard of those rights.
While nearly every section of the amendment is disheartening, several
sections stand out.
Reducing Public Awareness
SEC. 201: Administrative Revision of the Vaccine Injury Table
S 2053 cuts in half the time allowed for public comment (from 180 days to 90
days) when a change in the Vaccine Injury Table is proposed. It further
eliminates the Secretary of HHS' obligation to hold a public hearing on the
issue. The effect is to drastically reduce the already scant public
participation in this Program.
Removing All "OPT-OUT" Actions
SEC. 202: Equitable Relief
S 2053 begins, here in Sec. 202, the first of its several-pronged attack,
and ultimately, elimination of, the various forms of civil actions currently
ongoing throughout the country, including the class actions seeking medical
monitoring. By including the language "equitable relief' in the damages or
awards sought section, S 2053 clearly removes the possibility of civil suits
seeking medical monitoring, or other, non-monetary awards. Medical
monitoring suits are specifically eliminated in SEC. 214. The effect of this
provision, along with Sections 203-204 and 214-217 is to make sure that
anyone with an injury from a vaccine MUST go through the Program first, and
all class actions of any kind are eliminated.
SEC. 203: Parent Petitions for Compensation
S 2053 eliminates parental claims for loss of consortium, society,
companionship or services, loss of earnings, medical or other expenses, and
emotional distress until after a claim has been made through the Program.
The effect of this provision is to, again, make sure everyone has to go
through the Program first, and eliminates another form of the civil suits
ongoing across the country. The irony here is that the bill does not create
damages for parents under the program, which are comparable to civil
damages, and it does not make it clear that parental claims in the civil
system will have their statutes of limitations tolled by filing a child's
claim in the program. The practical effect of this may be to eliminate
parental claims altogether.
SEC. 214: Clarification of Standards of Responsibility
S 2053 requires, in this section, a "present physical injury", preventing
any actions for medical monitoring. The section further specifically adds
the "equitable relief' language and eliminates actions for claims of
"medical monitoring, or increased risk of harm". This provision may have the
added effect of denying compensation to someone who had a terrible injury
under the program which lasted for some period of time (even years), but who
has now recovered and does not have a "present physical injury." This is a
good example of how drafting language with one purpose may have other
dramatic, unintended consequences.
SEC'S. 215-217: Clarification of Definitions of Manufacturer,
Vaccine-Related Injury or Death and Vaccine
S 2053, in these three sections, affirmatively states that an "adulterant or
contaminant shall not include any component or ingredient listed in a
vaccine's product license application or product label." The purpose of
these clarifications is to eliminate the legal theory that Thimerosal is a
contaminant or adulterant.
SEC. 204: Jurisdiction to Dismiss Actions Improperly Brought
S 2053 gives the manufacturers the right to remove to the US Court of
Federal Claims any civil action against the manufacturer, brought by a
family without first going through the Program, and requires the USCFC to
dismiss the action. SEC. 204 works in tandem with 202-203 and 214-217 in
preventing direct actions against the manufacturers.
With parental claims, medical monitoring and Thimerosal as adulterant
representing the only options for families outside of the Program, the Frist
amendment acts as a three strikes and you're "in" bill, effectively
preventing any direct action against a vaccine manufacturer without first
going through the Program.
Strengthening Goliath's Position
SEC. 206: Clarification of When Injury is Caused By Factors Unrelated to
Administration of Vaccine
S 2053 gives the Government additional weapons in its arsenal to knock down
petitioners' arguments and ultimately deny claims. It does so by creating
"new~~ causes for the injury that Frist's amendment deems "unrelated" to the
vaccine. This provision allows the Respondent to use medical ignorance to
deny compensation. The government normally has to prove alternate causes of
injuries. Senator Frist wants to give them presumptive alternate causes. The
result will be to deny compensation to even more claimants. Proving
causation with one's hands tied behind the back is hard enough, but Frist
wants to tilt the playing field even further, and the children be damned.
Weakening David's Position
SEC. 208: Basis for Calculating Projected Lost Earnings
S 2053 destroys Petitioners' hard-fought and grudgingly conceded progress in
getting realistic and "real world" compensation for injured children. The
amendment reinforces the Program's original language and gives the Secretary
of HHS the sole right to determine what is an "appropriate" formula for
determining projected lost earnings. In the past this "discretion" has led
to the absurd and contradictory result of injured children's projected
earnings being reduced by Social Security taxes, though they will never work
and pay into Social Security, AND being reduced by the FULL COST OF A HEALTH
INSURANCE POLICY (sometimes thousands of dollars) despite the fact that
"average" workers are NOT responsible for the full cost, but rather a
sharply reduced amount as their employer pays the balance. It has further
allowed the Government to selectively use data from the Bureau of Labor
Statistics while refusing to provide Petitioners with data.
Other Key Points
S 2053 fails to provide a "look back" provision, as in HR 3741 that will
allow hundreds of families to exercise their rights under the Program. This
is a tragic injustice
S 2053 fails to extend the statute of limitations for death cases - death
cases must still be filed within two years of the date of death.
S 2053 fails to provide for interim attorneys fees. The families of injured
children have a right to effective counsel. The children injured by vaccines
face an adversary of nearly unlimited financial and scientific resources.
Their cases reach levels of complexity, both medical and legal, that would
rival any toxic-tort class action. Their lawyers are, in effect, pro bono
representatives throughout the course of the case, often for years, and
unable to meet or even approach a level playing field with the Government's
S 2053 creates a brutal and unforgiving legal battle, ostensibly in the
"best interests" of injured children, strips them of their defenses and then
forces them onto the field. In short, S 2053 not only bloodies the
battlefield; it fails to render even basic aid to the wounded.
14 Commerce Drive, PH
Cranford, NJ 07016
July 30, 2002
Edward M. Kennedy, Chairman
Committee on Health, Education, Labor and Pensions
United States Senate
428 Dirkson Senate Office Building
Washington, DC 20510-6300
Re: Opposition to S. 2053 and Request for Public Hearings on Long
Overdue Reforms to the Vaccine Injury
Dear Senator Kennedy:
Safe Minds opposes S. 2053 (Improved Vaccine Affordability and
Availability Act) and requests a full investigation and
public hearings to explore appropriate solutions to problems with the
1986 Vaccine Injury Compensation Act (VICA). VICA,
intended as a swift and efficient alternative remedy to costly products
liability litigation, was supposed to provide appropriate
compensation to children injured by vaccines, while manufacturers were
afforded some relief from the uncertainties of civil
litigation in multiple fora without uniform rules. VICA was never
intended to be a substitute for or to preempt traditional civil
remedies, simply to provide a low-cost speedy alternative. VICA
recognized and implemented the essential principle in a just
society that the benefits of herd immunity through mandatory vaccination
cannot be obtained at the expense of imposing the
costs associated with vaccine injuries on a few children and families.
Since no vaccine, or system of vaccines, can be made
perfectly safe, society as a whole must bear responsibility for
injuries, death, and disease caused by vaccines.
Safe Minds is a non-profit parents organization founded to
investigate the continuing risks to infants and children of
exposure to mercury from medical products, including thimerosal in
vaccines. Its Web site is www.safeminds.com.
S. 2053 effectively destroys the traditional civil tort remedies
left intact by VICA without fixing the severe problems that
have developed during fifteen years of experience under the
well-intentioned, but seriously flawed, VICA program
Vaccine companies already enjoy immunity from individual
liability unprecedented under American law. The principle that
the law provides a remedy for every injury is an ancient component of
the rule of law. S. 2053 contains a significant expansion
of that immunity. For example, Section 203 extinguishes parental claims
for medical expenses, and loss of companionship and
consortium. Sections 215-217 bar claims based upon injuries from
contaminants and adulterants. Sections 202 and 214
preclude equitable relief, such as scientific studies and medical
Such a radical change in the rules governing compensation for
vaccine injuries should not be made without full public
hearings and debate. Moreover, the vaccine companies are presently
seeking passage of S. 2053 as a complete defense
(immunity) from recent lawsuits filed across the country by parents
seeking compensation for injuries caused by mercury
(thimerosal) added to many vaccines as a preservative. The Institute of
Medicine (IOM) recently found in a 2001 report that it
was biologically plausible that the doses of mercury received my infants
from vaccines could indeed cause or contribute to a
host of cognitive and neurological disorders ranging from autism
spectrum disorders (ASD) to ADHD. IOM recommended a
comprehensive program of medical and scientific research to fully study
the extent of injuries to these children. Although the
mercury in pediatric vaccines was largely removed by 2001 under
pressure from Safe Minds and others parents groups and
CongressVICA does not presently contain procedures to effectively
redress these injuries. It is unconscionable to slam the
door on any relief for perhaps 500,000 familieswho may face expenses for
lifetime care of several million for a seriously injured
childwithout providing for an alternative and effective remedy.
While it might seem desirable at first blush to channel all
claims for vaccine injuries, regardless of cause or plaintiff, to a
single specialized court, S. 2053 in fact goes too far and is contrary
to the public interest. S. 2053 essentially destroys effective
traditional tort remedies by eliminating class actions, imposing an
unrealistic short statute of limitations, disallowing traditional
tolling provisions until injuries are manifest, limiting compensation to
a fraction of potential lifetime expenses, extinguishing
punitive damages, shifting the burden of proof from manufacturers to
parents, and imposing a novel and unreasonably difficult
standard of causation.
S. 2053's expanded immunity from traditional tort liability is
contrary to the recently debated and restated intent of
Congress and the Administration to hold corporations and their
executives accountable for their actions. The mandated use of
vaccines will continue to produce unprecedented profit opportunities.
Vaccine companies must be liable in tort if they
marketed vaccines without proper safety testing to assess the long-run
risks of mercury, with its long history of neuro- and
immuno-toxicity, used as a preservative, as well as the long-run risks
of exposure to an increasing number of biologically active
agents, often administered on the same day or in combination vaccines
such as the MMR. The FDA announced in the Federal
Register in 1982 that thimerosal was both toxic and largely ineffective,
and began its removal from consumer products. The
medical and scientific literature is replete with studies documenting
the toxicity of bioavailable mercury in its various forms,
including thimerosal. Manufacturers nevertheless continued to increase
the burden of mercury injected into infants without
demonstrating safety. Ironically, mercury need not have been used at
all, with vaccines delivered as a single dose or in
multi-dose vials with an alternative non-toxic preservative. Congress
must not lessen the standards of accountability after the
manufacturers made their choices and the injuries were sustained.
For the future, expanded immunity provides perverse incentives
for less safe vaccines and will necessarily undermine
public trust and confidence essential to an effective nationwide program
of herd immunity.
VICA is badly broken and is long overdue for review and
adjustment. Emergency passage of S. 2053, in secret and
without public hearings, is not the solution. Rather than restoring
balance to the Act, as its proponents claim, S. 2053 would
eviscerate legitimate claims brought by desperate families badly in need
of compensation for serious vaccine injuries. The Act,
with its very short statute of limitations, was originally designed to
process claims for injuries that were immediately apparent,
such as sudden death and seizures, and not intended to deal adequately
with injuries whose manifestation was delayed or
where the injuries only appeared after the cumulation of effects as part
of an overall system of vaccine mandates.
Aside from conferring additional and unjustified immunities, S.
2053 does nothing to fix the serious defects in VICA. For
example, it provides no look back provision, which would allow
families to seek compensation in the special vaccine court,
or otherwise, for vaccine injuries based on the eventual findings of the
research program ordered by IOM. HR 3741, a
bipartisan bill introduced by Dan Burton and Henry Waxman, provides a
much better vehicle to fix VICA, and should be the
subject of hearings and full public consideration by the Senate.
Some proponents claim that the Bill is needed now to address
alleged supply problems. Whatever problems exist are the
result of, for example, long overdue FDA enforcement actions concerning
violations of good manufacturing practices, and the
need to redesign some vaccines to remove toxic mercury, and not the
result of any deficiencies in the VICA. Any industry
claims that they will stop making vaccines or withhold research spending
on new vaccines are patently absurd, as
manufacturers are allowed huge profits on products the use of which is
mandated by law.
S. 2053 expressly preempts all equitable relief. Several states
have provided for court-mandated medical monitoring and
scientific studies (of the type ordered by the IOM) in order to
establish a sound scientific basis for causation, liability, and
treatment. Families have filed several suits throughout the country
seeking industry funding of such studies to establish, or
refute, the link between vaccines and neurological injury. To date,
Congress has not allocated funds to conduct the IOM
studies. S. 2053 thus has serious federalism implications and will
stifle critical research and studies essential to resolution of the
debate over the role vaccines play in neurological injury.
In conclusion, the Committee must not report out S. 2053. It is
a misguided attack on VICA and traditional civil
remedies that would confer dangerous and unprecedented immunity on
vaccine manufacturers for their past wrongful acts.
VICA is broken and badly in need of examination and repair, but this
must be done in public with full and fair debate.
Hundreds of thousands of families are counting on the Committee and
Congress to ensure them full and complete accountability
and compensation for injuries and costs they were sadly forced to incur
allegedly for the overall good of society.