[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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