I 
109TH CONGRESS 
1ST SESSION H. R. 3970 
To amend title 28, United States Code, to provide liability protections for 
certain pandemics and countermeasures. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 6, 2005 
Mr. ISSA introduced the following bill; which was referred to the Committee 
on the Judiciary, and in addition to the Committee on Energy and Com-
merce, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
A BILL 
To amend title 28, United States Code, to provide liability 
protections for certain pandemics and countermeasures. 
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 ‘‘Bioterror and Pan-
demic Preparedness Protection Act’’.
SEC. 
2. 
LIABILITY 
PROTECTIONS 
FOR 
PANDEMICS, 
EPIDEMICS, AND COUNTERMEASURES. 
(a) IN GENERAL.—Part VI of title 28, United States 
Code, is amended by adding at the end the following new 
chapter: 
‘‘CHAPTER 181—LIABILITY PROTECTION 
FOR CERTAIN PANDEMICS AND COUN-
TERMEASURES 
‘‘Sec. 
‘‘4101. Liability protections for pandemics, epidemics, and security counter-
measures. 
‘‘§ 4101. 
Liability 
protections 
for 
pandemics, 
epidemics, and security countermeasures 
‘‘(a) AUTHORITY.—The Attorney General shall be 
solely and exclusively responsible for the administration of 
this section. This section shall apply with respect to the 
design, development, clinical testing and investigation, 
manufacture, labeling, distribution, sale, purchase, dona-
tion, dispensing, administration, or use of a security coun-
termeasure or a qualified pandemic or epidemic product. 
‘‘(b) LITIGATION MANAGEMENT.— 
‘‘(1) FEDERAL CAUSE OF ACTION.— 
‘‘(A) IN GENERAL.—There shall exist an 
exclusive Federal cause of action for all claims 
for loss of property, personal injury, bodily in-
jury, including mental anguish, or death arising 
out of, relating to, or resulting from the design,
development, clinical testing and investigation, 
manufacture, labeling, distribution, sale, pur-
chase, donation, dispensing, administration, or 
use of a qualified pandemic or epidemic product 
or a security countermeasure as provided for in 
clauses (i) and (ii) of paragraph (2)(B). Section 
1346(b) and Chapter 17 of title 28, United 
States Code, shall not apply to the cause of ac-
tion provided for in this paragraph. Such cause 
of action shall be exclusive of any other civil ac-
tion or proceeding relating to the same subject 
matter. 
‘‘(B) ACTION.—With respect to the Fed-
eral cause of action provided in subparagraph 
(A)— 
‘‘(i) an action may be commenced 
solely and exclusively against the United 
States for claims identified in subpara-
graph (A) that are against a manufac-
turer, distributor, or health care provider; 
‘‘(ii) no cause of action shall be main-
tained against a manufacturer, distributor, 
or health care provider for claims identified 
in subparagraph (A); and
‘‘(iii) if the product is described in 
paragraph (2)(B)(ii) and is not described 
in clause (i) of such paragraph, the protec-
tions set forth in clauses (i) and (ii) shall 
apply to all claims identified in subpara-
graph (A) that involve products sold, pur-
chased, donated, dispensed, or adminis-
tered during the effective period set forth 
in the designation provided for in para-
graph (2)(F), regardless of the date of al-
leged injury. 
‘‘(C) JURISDICTION.—The United States 
District Court for the District of Columbia shall 
have sole and exclusive jurisdiction over any 
claim for loss of property, personal injury, or 
death arising out of, relating to, or resulting 
from the design, development, clinical testing 
and investigation, manufacture, labeling, dis-
tribution, sale, purchase, donation, dispensing, 
administration, or use of a qualified pandemic 
or epidemic product or security countermeasure 
as provided for in clauses (i) and (ii) of para-
graph (2)(B). The substantive law with respect 
to a decision in any such action shall be derived 
from the law, including choice of law principles,
of the State in which such action arose, unless 
such law is inconsistent with or preempted by 
Federal law. 
‘‘(2) AFFIRMATIVE DEFENSE.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (C), neither the Federal Govern-
ment nor a manufacturer, distributor, adminis-
trator, or health care provider shall be liable in 
an action described in subparagraph (B). 
‘‘(B) ACTION DESCRIBED.—An action de-
scribed in this subparagraph is an action that 
is commenced against the United States for 
claims arising out of, relating to, or resulting 
from the design, development, clinical testing 
and investigation, manufacture, labeling, dis-
tribution, sale, purchase, donation, dispensing, 
prescribing, administration, or use of— 
‘‘(i) a security countermeasure that 
has been procured for or donated to the 
Strategic National Stockpile under section 
319F–2 of the Public Health Service Act 
or a qualified pandemic or epidemic prod-
uct that has been procured or donated to 
the Secretary of Health and Human Serv-
ices; or
‘‘(ii) a security countermeasure or 
qualified pandemic or epidemic product 
distributed, sold, purchased, donated, dis-
pensed, administered, prescribed, or used 
in anticipation of and preparation for, in 
defense against, or in response to or recov-
ery from an actual or potential public 
health emergency, that is a designated se-
curity countermeasure or a qualified pan-
demic or epidemic product by the Sec-
retary of Health and Human Services in a 
public health emergency as described in 
paragraph (1) or (2) of section 319(a) of 
the Public Health Service Act. 
‘‘(C) POTENTIAL LIABILITY UPON DETER-
MINATION.— 
‘‘(i) IN
GENERAL.—A manufacturer, 
distributor, administrator, or health care 
provider may be liable in any action de-
scribed in subparagraph (B) only if the At-
torney General makes a determination as 
provided for in subparagraph (D). 
‘‘(ii) INVESTIGATION
BY
ATTORNEY 
GENERAL.—A party seeking a determina-
tion under subparagraph (D) may petition
the Attorney General to investigate allega-
tions against a manufacturer, distributor, 
administrator, or health care provider aris-
ing out of, relating to, or resulting from 
the design, development, clinical testing 
and investigation, manufacture, labeling, 
distribution, sale, purchase, donation, pre-
scribing, dispensing, administration, or use 
of products as provided for in clauses (i) 
and (ii) of subparagraph (B). The decision 
to undertake such investigation shall be 
within the Attorney General’s discretion 
and shall not be subject to judicial review. 
‘‘(D) DETERMINATION BY ATTORNEY GEN-
ERAL.— 
‘‘(i) IN GENERAL.—In making a de-
termination under this subparagraph, the 
Attorney General must find clear and con-
vincing evidence that the manufacturer, 
distributor, administrator, or health care 
provider intentionally or with willful dis-
regard violated a provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) or the Public Health Service 
Act and such violation—
‘‘(I) 
caused 
the 
product 
to 
present a significant or unreasonable 
risk to human health; and 
‘‘(II) proximately caused the in-
jury alleged by the party. 
‘‘(ii) NOTICE AND HEARING.—Prior to 
the Attorney General’s making a deter-
mination under clause (i), the manufac-
turer, distributor, administrator, or health 
care provider shall have notice and a right 
to a formal hearing in accordance with sec-
tion 556 of title 5, United States Code. 
‘‘(iii) EFFECT OF DETERMINATION.— 
If the Attorney General makes an affirma-
tive determination under clause (i), a case 
may proceed against a manufacturer, dis-
tributor, administrator, or health care pro-
vider involved. 
‘‘(iv) JUDICIAL REVIEW.—At any time 
prior to the 90th day following a deter-
mination by the Attorney General under 
clause (i) of this subparagraph, any manu-
facturer, distributor, administrator, or 
health care provider named in such deter-
mination may file a petition with the
United States Court of Appeals for the cir-
cuit wherein such person resides or has his 
principal place of business, for a judicial 
review of such determination. A copy of 
the petition shall be forthwith transmitted 
by the clerk of the court to the Attorney 
General or other officer designated by the 
Attorney General for that purpose. The At-
torney General thereupon shall file in the 
court the record of the findings on which 
the Attorney General based his or her de-
termination. The filing of a petition under 
this clause shall automatically stay the At-
torney General’s determination for the du-
ration of the judicial proceeding. The sole 
parties to the judicial proceeding shall be 
the Attorney General and the petitioner. 
Intervention by third parties in the judicial 
proceeding shall not be permitted. No sub-
poenas shall be issued nor shall other com-
pulsory process apply. The court’s review 
of a determination by the Attorney General 
under this clause shall conform to the pro-
cedures for judicial review of administra-
tive orders set forth in paragraphs (2)
through (6) of section 701(f) of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 371(f)), to the extent consistent 
with this section. 
‘‘(v) TOLLING OF STATUTE OF LIMI-
TATIONS.—The computation of the statute 
of limitations for any action against a 
manufacturer, distributor, administrator, 
or health care provider described under 
this subparagraph shall not include any 
time occurring before the determination by 
the Attorney General under this subpara-
graph. 
‘‘(E) SCOPE.—Subparagraph (C) shall 
apply regardless of whether the claim against 
the United States arises from the design, devel-
opment, clinical testing and investigation, man-
ufacture, labeling, distribution, sale, purchase, 
donation, dispensing, prescribing, administra-
tion, or use by the Federal Government or by 
any person. 
‘‘(F) DESIGNATION.—In any declaration of 
a public health emergency under section 319 of 
the Public Health Service Act, or in a separate 
declaration under such section, the Secretary of
Health and Human Services may, if necessary, 
identify the pandemic, epidemic, or biological, 
chemical, nuclear agent, or toxin that presents, 
or may present, a public health emergency and 
shall designate the security countermeasure(s) 
or qualified pandemic or epidemic product(s) to 
be sold by, purchased from, or donated by a 
manufacturer or drawn from the Strategic Na-
tional Stockpile and shall specify in such des-
ignation the beginning and ending dates of such 
sale, purchase, donation, or use from the stock-
pile. The period so defined shall be the effective 
period of such qualification for any products 
specified in the designation. The declaration 
shall subsequently be amended to reflect any 
additional sale, purchase, or donation of prod-
ucts specified in the designation. 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) ADMINISTRATOR.—The term ‘adminis-
trator’ means— 
‘‘(A) a person who administers, dispenses, 
distributes, or otherwise provides a security 
countermeasure or a qualified pandemic or epi-
demic product to a person to diagnose, miti-
gate, treat, identify, cure, or prevent harm 
from— 
‘‘(i) a pandemic or epidemic or any bi-
ological, chemical, radiological, or nuclear 
agent; or 
‘‘(ii) a serious or life-threatening dis-
ease or condition caused by such counter-
measure or product; or 
‘‘(B) a person that has established require-
ments, provided policy guidance, supplied tech-
nical or scientific advice or assistance, or other-
wise supervised or administered a program with 
respect to the administration, dispensing, dis-
tribution, or provision of a security counter-
measure or a qualified pandemic or epidemic 
product. 
‘‘(2) HEALTH
CARE
PROVIDER.—The term 
‘health care provider’ means a person, including a 
volunteer, who lawfully prescribes, administers, dis-
penses, or provides a facility to administer a security 
countermeasure or a qualified pandemic or epidemic 
product, including persons who prescribe, admin-
ister, or provide a facility to administer in accord-
ance with a designation under subsection (b)(2)(F).
‘‘(3) LOSS.—The term ‘loss’ means death, bod-
ily injury, or damage to property, including business 
interruption loss. 
‘‘(4) QUALIFIED PANDEMIC OR EPIDEMIC PROD-
UCT.—The term ‘qualified pandemic or epidemic 
product’ means a drug (as such term is defined in 
section 201(g)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)(1))), biological 
product (as such term is defined by section 351(i) 
of this Act) or device (as such term is defined by 
section 201(h) of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 321(h))) designed, developed, 
modified, or procured to diagnose, mitigate, prevent, 
treat, or cure a pandemic or epidemic or limit the 
harm such pandemic or epidemic might otherwise 
cause or a serious or life-threatening disease or con-
dition caused by such a product, that— 
‘‘(A) is approved or cleared under chapter 
V of the Federal Food, Drug, and Cosmetic Act 
or licensed under section 351 of the Public 
Health Service Act; 
‘‘(B) is a product for which the Secretary 
determines that sufficient and satisfactory clin-
ical experience or research data (including data, 
if available, from pre-clinical and clinical trials)
support a reasonable conclusion that the coun-
termeasure will qualify for approval or licensing 
within 8 years after the date the Secretary de-
clares a public health emergency as described in 
paragraph (1) or (2) of section 319(a) of the 
Public Health Service Act; or 
‘‘(C) is authorized by the Secretary of 
Health and Human Services under this section, 
except that the Secretary of Health and Human 
Services may authorize under thus section the 
emergency use of a product only if, after con-
sultation with the Director of the National In-
stitutes of Health and the Director of the Cen-
ters for Disease Control and Prevention (to the 
extent feasible and appropriate given the cir-
cumstances of the emergency involved), the Sec-
retary of Health and Human Services con-
cludes— 
‘‘(i) that an agent or toxin identi-
fied in a declaration described under 
subsection (b) can cause a serious or 
life-threatening disease or condition; 
‘‘(ii) that, based on the totality of 
the scientific evidence available to the 
Secretary of Health and Human Serv-
ices, including data from adequate 
and well-controlled clinical trials, if 
available, it is reasonable to believe 
that— 
‘‘(I) the product may be ef-
fective in diagnosing, mitigating, 
preventing, treating or curing— 
‘‘(aa) a pandemic or 
epidemic; or 
‘‘(bb) a serious or life 
threatening disease or condi-
tion caused by a product; 
‘‘(II) the known and poten-
tial benefits of the product, when 
used to diagnose, mitigate, pre-
vent, treat or cure such disease 
or condition, outweigh the known 
and potential risks of the prod-
uct; 
‘‘(iii) that there is no adequate, ap-
proved, and available alternative to the 
product for diagnosing, mitigating, pre-
venting, treating, or curing such disease or 
condition; and
‘‘(iv) that such other criteria as the 
Secretary of Health and Human Services 
may by regulation prescribe are satisfied. 
‘‘(5) PARTY.—The term ‘party’ means an indi-
vidual who can reasonably demonstrate to the Sec-
retary that such individual has suffered a loss (as 
defined above) as a direct result of the alleged mis-
conduct or illegal activities of a manufacturer, dis-
tributor, administrator, or health care provider. 
‘‘(6) PERSON.—The term ‘person’ includes an 
individual, partnership, corporation, association, en-
tity, or public or private corporation, including a 
Federal, State, or local agency or department. 
‘‘(7) SECURITY COUNTERMEASURE.—The term 
‘security countermeasure’ has the meaning given 
such term in section 319F–2(c)(1)(B) of the Public 
Health Service Act.’’. 
(b) CONFORMING AMENDMENT.—The table of chap-
ters for part VI of title 28, United States Code, is amend-
ed by adding after the item relating to chapter 180 the 
following new item: 
‘‘181. Liability protection for certain pandemics and 
countermeasures .................................................... 4101’’. 
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