I 
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 Com-
mittee 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 juris-
diction 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 Representa-
tives 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 signifi-
cant public health advances in history. They have 
saved millions of lives and prevented millions of dis-
abilities. 
(2) Vaccines are now available for preventing 
once common childhood diseases, such as polio, 
chicken pox, and measles, and for preventing dis-
eases 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 re-
ceiving the vaccine, they benefit others in the com-
munity 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 litiga-
tion 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 short-
age in the United States. The Secretary indicated 
that the souring of the vaccine manufacturing mar-
ketplace was due, in part, to ‘‘costly liability law-
suits’’. 
(7) The Congress intervened in 1986 by cre-
ating a no-fault compensation system called the Na-
tional Vaccine Injury Compensation Program, which 
was intended to lower the legal risk to vaccine man-
ufacturers, encourage a stable supply of vaccine, and 
ensure that injured patients are rapidly and appro-
priately compensated. 
(8) Under the National Vaccine Injury Com-
pensation 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 dam-
ages for medical expenses, rehabilitation expenses, 
and lost earnings, as well as pain and suffering dam-
ages subject to a $250,000 cap. Over 1,800 claims 
have been paid totaling over $1,500,000,000 for vac-
cine-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 com-
panies still face significant and expensive litigation 
exposure, in part, because—
(A) the National Vaccine Injury Com-
pensation 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 by-
pass the the Program and elect to go to trial 
by alleging that a particular vaccine is not cov-
ered under the Program, or that the Program 
does not apply to certain preservatives, compo-
nents, or ingredients of any such vaccine; and 
(C) the Program does not preclude an indi-
vidual who is otherwise ineligible to file a claim 
under the Program (such as family members of 
injured individuals) from pursuing civil litiga-
tion. 
(10) To ensure that litigation involving feder-
ally 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 legiti-
mate claims are more rapidly and fairly compensated 
by the National Vaccine Injury Compensation Pro-
gram 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 Child-
hood Vaccines, jointly study and submit a report to 
the Congress within one year regarding their rec-
ommendations. 
(b) PURPOSES.—The purposes of this Act are to—
(1) establish reasonable legal reforms that will 
facilitate the manufacture of vital, life-saving vac-
cines; 
(2) establish certain legal rules and procedures 
to better assure that litigation involving federally ap-
proved 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-re-
lated injury or death associated with the administra-
tion of a vaccine after October 1, 1988. The sub-
stantive 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, in-
cluding 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 vac-
cine-related injury or death associated with the ad-
ministration of a vaccine after October 1, 1988, in-
cluding 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 pursu-
ant 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 adminis-
tration 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 dis-
missed by the State court, the action may be re-
moved at any time before final judgment by any de-
fendant 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 ac-
tion removed pursuant to this subsection is an ap-
pealable order. Except as provided herein, the re-
moval 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 ac-
tion for damages arising from, or equitable relief re-
lating 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 ATTOR-
NEYS WHO COMMIT MULTIPLE RULE 11 VIO-
LATIONS. 
(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’’), de-
termines that an attorney has violated Rule 11 of the Fed-
eral 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 prac-
tice of law in that district court for 1 year; and 
(2) may suspend that attorney from the prac-
tice of law in that district court for any additional 
period that the court considers appropriate. 
(b) APPEAL; STAY.—An attorney has the right to ap-
peal a suspension under subsection (a). While such an ap-
peal is pending, the suspension shall be stayed. 
(c) REINSTATEMENT.—To be reinstated to the prac-
tice of law in a district court of the United States after 
completion of a suspension under subsection (a), the attor-
ney must first petition the court for reinstatement under 
such procedures and conditions as the court may pre-
scribe. 
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 (includ-
ing 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 fol-
lowing: 
‘‘(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 eq-
uitable 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 pend-
ing in State court, the claim shall be dismissed with preju-
dice. 
(c) NOTICE FILED.—If a notice is filed for a claim 
described in subsection (a) within such 30-day period de-
scribed in such subsection, and the claim is pending in 
State court prior to the entry of final judgment, any plain-
tiff or defendant may remove the action to the district 
court of the United States for the district and division em-
bracing the place where such action is pending by filing
a notice of removal signed pursuant to Rule 11 of the Fed-
eral 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 pre-
viously filed in such action. Promptly after the filing of 
such notice of removal, the removing party shall give writ-
ten 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 ap-
pealable 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 sub-
section (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 Vac-
cine 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 ran-
cor and substantial delays often associated with tra-
ditional litigation. 
(2) Although the National Vaccine Injury Com-
pensation Program maintains it has an excellent 
record of promptly and appropriately compensating 
valid claims, recent reports of some individuals seek-
ing 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 alter-
native to tort litigation. 
(b) STUDY.—After considering the findings in sub-
section (a), and after consulting with the Advisory Com-
mission 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 com-
pensated in a less adversarial manner.
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