Vaccine Injury Program- Briefing Paper

From: "KD Weber"
Fw: Vaccine Injury Program- Briefing Paper

Briefing Paper- Homeland Security and Vaccine Compensation
Prepared by: The National Vaccine Information Center
http://www.nvic.org/
421 Church Street, Suite E
Vienna, VA 22180
703-938-0342

What is the Vaccine Injury Compensation Program? The National Childhood Vaccine
Injury Act of 1986, Public Law 99-660, was a landmark vaccine safety and
compensation law, passed by Congress after five years of effort by the National
Vaccine Information Center, the American Academy of Pediatrics, and several
vaccine manufacturers.

Physician organizations and vaccine manufacturers were seeking fewer lawsuits
and they asserted that this would help insure the availability of vaccines and
result in reduced prices.

Parents were seeking a less expensive, less time consuming and emotionally
draining alternative to a lawsuit. When the law was passed, parents who had
pending lawsuits made a choice between the VICP and continuing their law suit..
NVIC insisted on preserving the right to go to court if the VICP ruled against
them or the award was not sufficient to care for the injured child.

What other provisions were part of the law? Parents fought hard to have safety
provisions as part of the law in an effort to prevent other children from
suffering a vaccine injury or death.

Compensation without prevention was not acceptable.
1. All doctors who administer vaccines must report vaccine reactions to federal
health authorities. The Vaccine Adverse Events Reporting System (VAERS) was
created as a centralized reporting system for vaccine adverse events.
2. All doctors are required to record vaccine reactions in the patient's
permanent medical record, in an effort to prevent a child from being
revaccinated after a previous reaction.
3. Doctors are required to keep a record of the date, manufacturer's name and
lot number of the vaccines given, making it easier to obtain that information
and assist in identifying especially reactive lots of vaccine.
4. Doctors are required to provide parents with written information prior to
delivery of the vaccinations, in an effort to help parents make better-informed
decisions.
5. The Federal Government is required to promote the improvement of existing
vaccines and the development of safer vaccines; so fewer children would suffer
an adverse event.

How is this connected to Homeland Security? The VICP has a very short statute of
limitations (time in which to file a claim), of 3 years for a vaccine injury and
2 years for a death resulting from a vaccination. In the past ten years autism
has increased by 500% in most states and some parents associate their child's
autism with an MMR vaccine reaction or with Thimerosal, a preservative used in
some vaccines for many years. Thimerosal is a mercury derivative (a known
neuro-toxin) used in killed and recombinant vaccines to prevent the growth of
bacteria in multi-dose vials. In 1999 the government recommended drug companies
remove Thimerosal from vaccines and produce single-dose vials, which would not
require a preservative.
A diagnosis of autism is very rarely made in time for a child to qualify for the
VICP. This has led to a large number of lawsuits that are outside of the VICP
that are in state court. Most states have ruled against these cases due to the
jurisdictional issue.

On November 13, 2002, the Homeland Security Bill was passed by the House of
Representatives and sent to the Senate. Originally intended to set up a new
Department of Homeland Security, the 484-page bill also provided for the biggest
reorganization in government since 1947. The last four sections of the bill,
(1714-1717) shielded the pharmaceutical industry from lawsuits for injuries
caused by FDA-approved vaccines, such as mercury containing pediatric vaccines
associated with the development of autism.

Senators Lieberman, Daschle and Byrd proposed an amendment to strike out the
vaccine injury liability bailout but it was voted down 47-52. Reports have come
out of last minute deals between the White House and rebellious republicans
(Senators Snowe, Collins and Chafee) who threatened to vote for the Lieberman
amendment. Promises were made that in the new Congress a bill would be passed
that would allow existing lawsuits to continue but would bar all future
lawsuits.

After much debate the Homeland Security Bill passed the Senate. The four-day
debate was covered live on C-Span as Democrats and Republicans squared off on
this last minute provision that really had nothing to do with Homeland Security.
Articles ran on the front pages of major newspapers and headlined the evening
news.

Why do we need to preserve the right to bring a lawsuit when we have the VICP?
Children are required by law to be vaccinated before entering daycare, school or
college. This is a medical procedure that carries a risk of injury or death and
is performed on a healthy individual. There is great debate in the scientific
community about which vaccines cause injuries and what those injuries are. It is
going to take a long time for science to find all the answers. In the meantime,
if even a small percentage of children are injured by mercury, the MMR or any
other vaccine that our government requires parents to use, then those children
should be entitled to compensation and fair treatment within the system.

It would be the greatest injustice to require vaccination by law, knowing that
some children will be permanently brain-damaged or even die as a result and then
to single out these children and their parents to taking away their right to
common law protection from negligence or unreasonably dangerous products, and
making them the only group who do not have the right to go to court. That is
hardly real justice, nor good social policy.

The tort system serves to deter negligence and helps augment regulatory
incentives for safety. Without the threat of a lawsuit if the VICP does not
handle cases fairly or adequately, there is no incentive for drug companies to
make their vaccines as safe as possible. The drug companies end up with a
ready-made market and no liability.

What other provisions of the Homeland Security Act are troubling? Section 304 of
the bill removed from the states their historic control over public health laws,
including vaccination laws, and handed it over to federal health officials. This
section allows the Secretary of DHHS to issue a "declaration" after concluding
that "an actual or potential bioterrorist incident" or "other potential public
health emergency" warrants the administration of "a substance or substances" to
"individuals during the effective period of the declaration." The law provides
for no exemptions to vaccination or medication and is expected to override state
public health and vaccine laws which currently provide medical and/or religious
exemptions to vaccination for school entry. This federal law also does not
preclude the use of the U.S. military to enforce the administration of vaccines
or other "substances" to individuals as ordered by the Secretary of DHHS.

The Homeland Security Bill also eroded laws preventing the federal government
from conducting the people's business in secrecy, while creating new
opportunities for federal employees to look into the private lives of their
fellow citizens. Title 2 of the bill gives federal employees unchecked
surveillance power to access and track every American's email, internet use,
travel, credit card purchases, phone and bank records without a court order.
The public's right to know how government operates was also severely curtailed
in the bill with Section 214 gutting the Freedom of Information Act (FOIA),
which has allowed the media and private citizens to obtain documents and
transcripts of federal health agency meetings such as the FDA and CDC Advisory
Committees which regulate vaccines and make vaccine policy.

What is the current status of Homeland Security revisions? On January 10, 2003,
Senators Olympia Snowe (R-Maine), Susan Collins (R-Maine), and Lincoln Chafee
(R-R.I.) announced that they had reached an agreement with Senate leadership to
eliminate the thimerosal protection rider.

The agreement also calls on the Senate to consider and pass comprehensive
reforms to the Vaccine Injury Compensation program in the next six months which
could lead to a removal of lawsuits from the VICP if the award is not adequate
or the case is lost.

These changes were included in the Omnibus Appropriations Bill that passed on
February 14, 2003.

Attempted Legislative Changes: NVIC worked hard for the passage of a
compensation program and we have continued to serve as the consumer watchdog on
the implementation and use of the program. As of 12/31/02 there have been 7580
claims filed. Awards total $1.4 Billion while nearly 2 out of 3 claimants lose
their case.

NVIC has been a staunch critic of the way the program operates and has worked
hard for administrative and legislative changes. Beginning in 1999, Congressman
Dan Burton, Chairman of the House Government Reform Committee investigated
problems in the VICP. A number of issues were identified that led to the
introduction of a bill in February 2002 by Congressman Dan Burton (R-IN) and
Congressman Henry Waxman (D-CA). The legislative reforms proposed by
Burton/Waxman included:

· Extending the statute of limitations for filing a petition in the Vaccine
Injury Compensation Program to six years and establishing a two-year window for
families to file a petition if they were previously excluded from the Program by
the existing statute of limitations.
· Increasing the compensation for vaccine-related deaths to $300,000;
· Increasing the compensation for lost earnings;
· Including compensation for the costs of family counseling and creating a
guardianship;
· Including payment of interim attorneys fees and costs while a case is under
review.

In April 2002, Senator Bill Frist (R-TN), introduced a bill that would eliminate
all class action vaccine lawsuits, eliminate loss of consortium claims, remove
all state cases into federal court, not allow interim attorney fees, not allow a
one-time look back provision, and provide the government alternate causes to
help them disprove causation.

Neither of these two bills passed but portions of the Frist bill ended up in the
Homeland Security Act. All the more reason to suspect that Senator Frist will
attempt to give the drug companies an "exclusive remedy" in the compensation
program.