[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 650 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 650
To establish reasonable legal reforms that will facilitate the
manufacture of vital, life-saving vaccines, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 8, 2005
Mr. Keller introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
the Judiciary, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To establish reasonable legal reforms that will facilitate the
manufacture of vital, life-saving vaccines, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Vaccine Accessibility for Children
and Seniors Act of 2005'' or the ``VACS Act of 2005''.
SEC. 2. FINDINGS; PURPOSE.
(a) Findings.--The Congress finds as follows:
(1) Vaccines represent one of the most significant public
health advances in history. They have saved millions of lives
and prevented millions of disabilities.
(2) Vaccines are now available for preventing once common
childhood diseases, such as polio, chicken pox, and measles,
and for preventing diseases responsible for high rates of
sickness and death among adults, including influenza,
pneumonia, and hepatitis.
(3) Vaccines reduce future medical costs and prevent the
need for more expensive drugs. Vaccines not only provide a
health benefit to the individual receiving the vaccine, they
benefit others in the community by reducing their chances of
exposure to a disease.
(4) The threat of litigation, coupled with the high cost of
manufacturing a vaccine, has forced many manufacturers to limit
or cease production of life-saving vaccines.
(5) In 1967, there were 26 companies in the United States
making these vital vaccines. A litigation crisis in the 1980's
drove many companies away from the vaccine business. Today,
there are only 4 companies that make the vast majority of
vaccines used in the United States, making the system fragile
and limiting access to vaccines.
(6) In October 2004, the Secretary of Health and Human
Services announced a flu vaccine shortage in the United States.
The Secretary indicated that the souring of the vaccine
manufacturing marketplace was due, in part, to ``costly
liability lawsuits''.
(7) The Congress intervened in 1986 by creating a no-fault
compensation system called the National Vaccine Injury
Compensation Program, which was intended to lower the legal
risk to vaccine manufacturers, encourage a stable supply of
vaccine, and ensure that injured patients are rapidly and
appropriately compensated.
(8) Under the National Vaccine Injury Compensation Program,
individuals who believe they have been injured by a vaccine may
file a claim in the United States Court of Federal Claims. If
found eligible, they can receive unlimited economic damages for
medical expenses, rehabilitation expenses, and lost earnings,
as well as pain and suffering damages subject to a $250,000
cap. Over 1,800 claims have been paid totaling over
$1,500,000,000 for vaccine-related injuries and complications
under the National Vaccine Injury Compensation Program, with
many awards amounting to more than $1,000,000 each, and some as
high as $7,500,000.
(9) Notwithstanding the intent of the National Vaccine
Injury Compensation Program, vaccine companies still face
significant and expensive litigation exposure, in part,
because--
(A) the National Vaccine Injury Compensation
Program allows all individuals to ``opt out'' of this
system and pursue individual and class action lawsuits
in State and Federal courts;
(B) trial attorneys continually seek to bypass the
the Program and elect to go to trial by alleging that a
particular vaccine is not covered under the Program, or
that the Program does not apply to certain
preservatives, components, or ingredients of any such
vaccine; and
(C) the Program does not preclude an individual who
is otherwise ineligible to file a claim under the
Program (such as family members of injured individuals)
from pursuing civil litigation.
(10) To ensure that litigation involving federally approved
vaccines is based on valid scientific evidence and does not
undermine the Federal public health policy of creating and
developing life saving vaccines, it is imperative that any
litigation involving vaccines, and related preservatives,
ingredients, and components, that takes place outside of the
National Vaccine Injury Compensation Program shall take place
exclusively in the district courts of the United States, where
all procedures and expert testimony shall be subject to the
rules and requirements set forth by the United States Supreme
Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S.
579, 113 S.Ct. 2786 (1993).
(11) To ensure that injured patients with legitimate claims
are more rapidly and fairly compensated by the National Vaccine
Injury Compensation Program in a less adversarial manner so as
to avoid the need for traditional civil litigation, it is
imperative that the Secretary of Health and Human Services and
the Attorney General of the United States, in consultation with
the Advisory Commission on Childhood Vaccines, jointly study
and submit a report to the Congress within one year regarding
their recommendations.
(b) Purposes.--The purposes of this Act are to--
(1) establish reasonable legal reforms that will facilitate
the manufacture of vital, life-saving vaccines;
(2) establish certain legal rules and procedures to better
assure that litigation involving federally approved vaccines is
based on valid scientific evidence;
(3) discourage frivolous litigation; and
(4) ensure that injured patients are rapidly and fairly
compensated in the appropriate forum.
SEC. 3. FEDERAL COURT REMEDY.
Section 2122 of the Public Health Service Act (42 U.S.C 300aa-22)
is amended by striking subsection (a) and inserting the following:
``(a) Federal Cause of Action.--
``(1) In general.--There shall exist a Federal cause of
action for claims arising from a vaccine-related injury or
death associated with the administration of a vaccine after
October 1, 1988. The substantive law for decision in any such
action shall be derived from this section and, unless
inconsistent with or preempted by Federal law, from the law,
including choice of law principles, of the State in which such
vaccine was administered. Except for a proceeding for
compensation under the National Vaccine Injury Compensation
Program, the cause of action established by this paragraph
shall constitute the exclusive cause of action or remedy for
any vaccine-related injury or death associated with the
administration of a vaccine after October 1, 1988, including
any related injury or loss sustained by any person (including
any relative or other third party).
``(2) Jurisdiction.--Except for a proceeding in the United
States Court of Federal Claims pursuant to section 2112, the
district courts of the United States shall have original and
exclusive jurisdiction over all actions for damages arising
from a vaccine-related injury or death associated with the
administration of a vaccine after October 1, 1988, including
any related injury or loss sustained by any person (including
any relative or other third party). If any civil action subject
to this section is brought or is pending in a State court, and
the action is not dismissed by the State court, the action may
be removed at any time before final judgment by any defendant
to the district court of the United States for the district and
division embracing the place where such action is pending. An
order remanding an action removed pursuant to this subsection
is an appealable order. Except as provided herein, the removal
of any such action shall proceed in accordance with sections
1446 through 1451 of title 28, United States Code.
``(3) State actions.--All State causes of action for
damages arising from, or equitable relief relating to, a
vaccine-related injury or death associated with a vaccine
administered after October 1, 1988, including for any related
injury or loss sustained by any person (including any relative
or other third party) are hereby preempted.
``(4) Vaccine defined.--For purposes of this section, the
term `vaccine' includes any preservative, ingredient, or
component of a vaccine.''.
SEC. 4. SANCTIONS FOR FRIVOLOUS VACCINE LITIGATION; 3-STRIKES RULE FOR
SUSPENDING ATTORNEYS WHO COMMIT MULTIPLE RULE 11
VIOLATIONS.
(a) Mandatory Suspension.--Whenever a district court of the United
States in connection with an action for damages arising from a vaccine-
related injury or death associated with a vaccine administered after
October 1, 1988 (in this section referred to as a ``vaccine suit''),
determines that an attorney has violated Rule 11 of the Federal Rules
of Civil Procedure, the court shall determine the number of times that
the attorney has violated that rule in connection with a vaccine suit
in that district court during that attorney's career. If the court
determines that the number is 3 or more, the district court of the
United States--
(1) shall suspend that attorney from the practice of law in
that district court for 1 year; and
(2) may suspend that attorney from the practice of law in
that district court for any additional period that the court
considers appropriate.
(b) Appeal; Stay.--An attorney has the right to appeal a suspension
under subsection (a). While such an appeal is pending, the suspension
shall be stayed.
(c) Reinstatement.--To be reinstated to the practice of law in a
district court of the United States after completion of a suspension
under subsection (a), the attorney must first petition the court for
reinstatement under such procedures and conditions as the court may
prescribe.
SEC. 5. TRIAL PROCEDURE.
(a) In General.--Section 2123 of the Public Health Service Act (42
U.S.C. 300aa-23) is amended--
(1) in subsection (a)--
(A) by striking ``three'' and inserting ``four'';
and
(B) by inserting ``, including any related injury
or loss sustained by any person (including any relative
or other third party),'' after ``the effective date of
this part'';
(2) by redesignating subsections (b), (c), (d) and (e) as
subsections (c), (d), (e) and (f);
(3) by inserting after subsection (a) the following:
``(b) Causation in Fact.--The first stage of such civil action
shall be held to determine whether competent and reliable scientific
evidence demonstrates that the plaintiff's alleged vaccine-related
injury or death was caused in fact by the vaccine.'';
(4) in subsection (c) (as so redesignated), by striking
``The first'' and inserting ``If the trier of fact finds that
the alleged vaccine-related injury or death was caused in fact
by the vaccine, a second'';
(5) in subsection (d) (as so redesignated), by striking
``second'' and inserting ``third''; and
(6) in subsection (e) (as so redesignated), by striking
``third'' and inserting ``fourth''.
(b) Conforming Amendment.--Subparagraph (A) of section 2122(b)(2)
of the Public Health Service Act (42 U.S.C. 300aa-22) is amended by
striking ``2123(d)(2)'' and inserting ``2123(e)(2)''.
SEC. 6. TRANSITION RULES.
(a) Notice.--If on the date of the enactment of this Act, any State
law claim for damages arising from, or equitable relief relating to, a
vaccine-related injury or death associated with a vaccine administered
after October 1, 1988, including any related injury or loss sustained
by any person (including any relative or other third party), is pending
in any State or Federal court prior to the entry of final judgment, the
plaintiff may, within 30 days of such date of enactment, file a notice
with the court in which the claim is pending electing to treat the
State law claim as a Federal law claim arising under section 2122 of
the Public Health Service Act, as amended by section 3, and subject to
the amendments made by this Act.
(b) Failure to File Notice.--If no notice is filed for a claim
described in subsection (a) within the 30-day period described in such
subsection, and the claim is pending in State court, the claim shall be
dismissed with prejudice.
(c) Notice Filed.--If a notice is filed for a claim described in
subsection (a) within such 30-day period described in such subsection,
and the claim is pending in State court prior to the entry of final
judgment, any plaintiff or defendant may remove the action to the
district court of the United States for the district and division
embracing the place where such action is pending by filing a notice of
removal signed pursuant to Rule 11 of the Federal Rules of Civil
Procedure and containing a short and plain statement of the grounds for
removal, together with a copy of all process, pleadings, and orders
served or previously filed in such action. Promptly after the filing of
such notice of removal, the removing party shall give written notice
thereof to all other parties and shall file a copy of the notice with
the clerk of such State court, which shall effect the removal, and the
State court shall proceed no further unless the case is remanded. An
order remanding an action removed pursuant to this subsection is an
appealable order. Except as provided herein, the removal of any such
action shall proceed in accordance with sections 1446 through 1451 of
title 28, United States Code. If a case is not properly removed within
40 days of the date of the enactment of this Act, any claim subject to
subsection (a) that remains pending in State court or that is remanded
to State court shall be promptly dismissed with prejudice.
SEC. 7. STUDY AND REPORT.
(a) Findings.--The Congress finds as follows:
(1) The Congress intended the National Vaccine Injury
Compensation Program to be a flexible, no-fault, less
adversarial system to handle claims in a quick, easy, and
generous manner so as to avoid the need the for civil
litigation, and to avoid the rancor and substantial delays
often associated with traditional litigation.
(2) Although the National Vaccine Injury Compensation
Program maintains it has an excellent record of promptly and
appropriately compensating valid claims, recent reports of some
individuals seeking compensation under the Program allege that
some legitimate claims have taken 5 to 10 years to resolve, the
process has become more adversarial, the Program has made
claims harder to prove, and the process has drifted toward
full-blown litigation and away from Congress' intent as a
positive alternative to tort litigation.
(b) Study.--After considering the findings in subsection (a), and
after consulting with the Advisory Commission on Childhood Vaccines,
the Secretary of Health and Human Services and the Attorney General of
the United States shall, not later than 1 year after the date of the
enactment of this Act, jointly submit a report to the appropriate
committees of the Congress concerning their recommendations to ensure
that injured patients with legitimate claims are rapidly and
appropriately compensated in a less adversarial manner.
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