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Talking Points Re Frist Amendment re Vaccine Program:

1. The
Institute of Medicine Vaccine Safety Review Committee, in its
official report on thimerosal and neurological disorders (including autism
and ADHD), on Oct. 1, 2001, found that it was
BIOLOGICALLY PLAUSIBLE that the
doses of mercury received by infants from 1990 until mercury was removed from
childhood vaccines in 1999 could indeed cause these disorders, and
recommended a comprehensive program of medical and scientific research to
study the extent of the injuries to these children.
a. The CDC and FDA and NIH do not have the money available to fund these
IOM- recommended studies.

2. Starting last year, many concerned parents have filed class actions
seeking to get state courts to order the vaccine and thimerosal manufacturers
to fund these studies. The vaccine manufacturers have tried to remove these
actions to federal court and get them dismissed. The federal courts all over
the country have rejected these industry maneuvers and have ordered the cases
back to state court in Washington, Oregon, California, Florida and elsewhere.

3. Last week, for the first time a state court denied the manufacturer's
motion to dismiss an individual claim for injuries from the mercury in infant
vaccines and send the case to the Vaccine Court, ruling that it was a fact
question as to whether the mercury in the vaccines was an "adulterant or
contaminant."

4. This bill would
completely shut down all of these state court actions,
stop them in their tracks, and eliminate any possibility that any court,
state, federal, or Vaccine Court, could ever order that the IOM recommended
studies on the effects of mercury in vaccines be funded by the manufacturers
who profited from the lower cost of using mercury to sell vaccines in
multidose vials.

5. On June 11, 2002, a federal court in Texas ruled that if an autistic
child who first showed symptoms of that disorder more than three years ago,
was not only barred from filing a petition under the Vaccine Act, but has
also lost all rights to sue in state court-that is, has no remedy at all in
any forum. The extension of the sol in this bill to six years leaves this
decision undisturbed, and in fact, codifies it with the addition of the
subtle language "timely filed petition" in sec. 22, of the amendment.

6. There is no "look back" provision to allow children and their parents
who just now or in the future discover that mercury in vaccines may have
caused their child to suffer from mercury poisoning to bring a claim. Since
almost all serious neurological disorders manifest themselves with some
symptom or sign by the age of 18 months, then even with a six year sol, any
child who is now 7.5 years old or older is still forever barred from bringing
a claim, anywhere, no matter what the research the IOM recommended uncovers.

7. Many states permit parents of an injured child to recover for their
personal loss due to the child's injuries, and the Vaccine Act never before
required these claims to be brought in Vaccine court.
This bill preempts all
such state laws.


8. By
eliminating all equitable relief (such as orders to industry to
fund the IOM studies), including explicitly medical monitoring, this bill
would ensure that these studies would most likely never be done.

9. The statute of limitations should be no more restrictive than the
applicable statute of limitations governing any child's claim in that child's
proper forum state. This is an issue of
basic constitutional right to trial.

a. At the time of original enactment of the Vaccine Compensation Act,
Congress was clear that it did not intend to lessen the rights of children
and their families, but was intending to offer attractive alternatives to
classic tort litigation.


10. This bill is contrary to the recently stated intent of the Administration
and Congress to
more closely supervise and monitor the illicit activities of
our nation's large corporations.
The Amendment would reward the
manufacturers of vaccines which clearly placed profit motives over the safety
of our nation's children.
The industry is given complete tort immunity,
notwithstanding the fact that the
pharmaceutical companies placed vaccines on
the market without testing the safety, or toxicity of the vaccines or the
components that make up those vaccines.
In the face of increasing knowledge
of the potential for mercury to cause neurological illness, the manufacturers
turned a deaf ear to the fact that their vaccines contained a potentially
dangerous amount of mercury-derived preservatives.

11. The bill
takes away rights of parents and spouses to seek redress in
state courts
for classically and statutorily recognized causes of action, by
completely extinguishing those rights.
a. One state's appellate courts has confirmed the existence of such
rights in the past year, and the First Circuit Court of Appeals has also
validated the rights of a spouse to a cause of action resulting from
his wife's devastating illness.

12. This bill gives
complete immunity to the manufacturers of mercury
laden vaccines and of thimerosal from ever having to pay for the studies that
the IOM Vaccine Safety Committee recommended; eliminates the power of any
court (state, federal or administrative) to require through equitable orders
that kids exposed to high doses of mercury be notified of their exposure and
that they be followed to see what additional injuries or disorders may
develop as they grow older; and if subsequent scientific studies do in fact
show mercury in vaccines caused neurological disorders in kids, any child
whose parents did not file a claim by the time they were 7.5 years old is
forever barred from receiving any compensation for those mercury induced
injuries, even though the legislatures of virtually every state in the Union
allow claims for injured children to be brought until they are over the age
of minority (eliminate so called "minority tolling".)
Feinstein State Office: SAN DIEGO
Eduardo Valerio, District Director
750 "B" Street, Suite 1030
San Diego, CA 92101
619/231-9712

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Analysis of the “Frist” Amendment (f/k/a S 2053)©
Vaccine Injury Alliance
Renee Gentry
Jeff Sell
www.vaccineinjury.org
www.HittPattersonSell.com
July 23, 2002

" S2053 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 petitioner 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 (PROBLEMS)

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 lawyers.

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.