H. R. 2863—147
(b) of section 2284 of title 28, United States Code, shall not 
apply to actions under subsection (d). 
‘‘(6) CIVIL DISCOVERY.—
‘‘(A) TIMING.—In an action under subsection (d), no 
discovery shall be allowed—
‘‘(i) before each covered person sued has had a 
reasonable opportunity to file a motion to dismiss; 
‘‘(ii) in the event such a motion is filed, before 
the court has ruled on such motion; and 
‘‘(iii) in the event a covered person files an inter-
locutory appeal from the denial of such a motion, before 
the court of appeals has ruled on such appeal. 
‘‘(B) STANDARD.—Notwithstanding any other provision 
of law, the court in an action under subsection (d) shall 
permit discovery only with respect to matters directly 
related to material issues contested in such action, and 
the court shall compel a response to a discovery request 
(including a request for admission, an interrogatory, a 
request for production of documents, or any other form 
of discovery request) under Rule 37, Federal Rules of Civil 
Procedure, only if the court finds that the requesting party 
needs the information sought to prove or defend as to 
a material issue contested in such action and that the 
likely benefits of a response to such request equal or exceed 
the burden or cost for the responding party of providing 
such response. 
‘‘(7) REDUCTION IN AWARD OF DAMAGES FOR COLLATERAL 
SOURCE BENEFITS.—
‘‘(A) IN GENERAL.—In an action under subsection (d), 
the amount of an award of damages that would otherwise 
be made to a plaintiff shall be reduced by the amount 
of collateral source benefits to such plaintiff. 
‘‘(B) PROVIDER OF COLLATERAL SOURCE BENEFITS NOT 
TO HAVE LIEN OR SUBROGATION.—No provider of collateral 
source benefits shall recover any amount against the plain-
tiff or receive any lien or credit against the plaintiff’s 
recovery or be equitably or legally subrogated to the right 
of the plaintiff in an action under subsection (d). 
‘‘(C) COLLATERAL SOURCE BENEFIT DEFINED.—For pur-
poses of this paragraph, the term ‘collateral source benefit’ 
means any amount paid or to be paid in the future to 
or on behalf of the plaintiff, or any service, product, or 
other benefit provided or to be provided in the future 
to or on behalf of the plaintiff, as a result of the injury 
or wrongful death, pursuant to—
‘‘(i) any State or Federal health, sickness, income-
disability, accident, or workers’ compensation law; 
‘‘(ii) any health, sickness, income-disability, or 
accident insurance that provides health benefits or 
income-disability coverage; 
‘‘(iii) any contract or agreement of any group, 
organization, partnership, or corporation to provide, 
pay for, or reimburse the cost of medical, hospital, 
dental, or income disability benefits; or 
‘‘(iv) any other publicly or privately funded pro-
gram.
H. R. 2863—148
‘‘(8) NONECONOMIC
DAMAGES.—In an action under sub-
section (d), any noneconomic damages may be awarded only 
in an amount directly proportional to the percentage of respon-
sibility of a defendant for the harm to the plaintiff. For purposes 
of this paragraph, the term ‘noneconomic damages’ means dam-
ages for losses for physical and emotional pain, suffering, 
inconvenience, physical impairment, mental anguish, disfigure-
ment, loss of enjoyment of life, loss of society and companion-
ship, loss of consortium, hedonic damages, injury to reputation, 
and any other nonpecuniary losses. 
‘‘(9) RULE 11 SANCTIONS.—Whenever a district court of the 
United States determines that there has been a violation of 
Rule 11 of the Federal Rules of Civil Procedure in an action 
under subsection (d), the court shall impose upon the attorney, 
law firm, or parties that have violated Rule 11 or are respon-
sible for the violation, an appropriate sanction, which may 
include an order to pay the other party or parties for the 
reasonable expenses incurred as a direct result of the filing 
of the pleading, motion, or other paper that is the subject 
of the violation, including a reasonable attorney’s fee. Such 
sanction shall be sufficient to deter repetition of such conduct 
or comparable conduct by others similarly situated, and to 
compensate the party or parties injured by such conduct. 
‘‘(10) INTERLOCUTORY APPEAL.—The United States Court 
of Appeals for the District of Columbia Circuit shall have juris-
diction of an interlocutory appeal by a covered person taken 
within 30 days of an order denying a motion to dismiss or 
a motion for summary judgment based on an assertion of the 
immunity from suit conferred by subsection (a) or based on 
an assertion of the exclusion under subsection (c)(5). 
‘‘(f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing 
in this section shall be construed to abrogate or limit any right, 
remedy, or authority that the United States or any agency thereof 
may possess under any other provision of law or to waive sovereign 
immunity or to abrogate or limit any defense or protection available 
to the United States or its agencies, instrumentalities, officers, 
or employees under any other law, including any provision of 
chapter 171 of title 28, United States Code (relating to tort claims 
procedure). 
‘‘(g) SEVERABILITY.—If any provision of this section, or the 
application of such provision to any person or circumstance, is 
held to be unconstitutional, the remainder of this section and the 
application of such remainder to any person or circumstance shall 
not be affected thereby. 
‘‘(h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE 
INJURY COMPENSATION PROGRAM.—Nothing in this section, or any 
amendment made by the Public Readiness and Emergency 
Preparedness Act, shall be construed to affect the National Vaccine 
Injury Compensation Program under title XXI of this Act. 
‘‘(i) DEFINITIONS.—In this section: 
‘‘(1) 
COVERED
COUNTERMEASURE.—The 
term 
‘covered 
countermeasure’ means—
‘‘(A) a qualified pandemic or epidemic product (as 
defined in paragraph (7)); 
‘‘(B) a security countermeasure (as defined in section 
319F–2(c)(1)(B)); or
H. R. 2863—149
‘‘(C) 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 Cosmetic 
Act (21 U.S.C. 321(h)) that is authorized for emergency 
use in accordance with section 564 of the Federal Food, 
Drug, and Cosmetic Act. 
‘‘(2) COVERED PERSON.—The term ‘covered person’, when 
used with respect to the administration or use of a covered 
countermeasure, means—
‘‘(A) the United States; or 
‘‘(B) a person or entity that is—
‘‘(i) a manufacturer of such countermeasure; 
‘‘(ii) a distributor of such countermeasure; 
‘‘(iii) a program planner of such countermeasure; 
‘‘(iv) a qualified person who prescribed, adminis-
tered, or dispensed such countermeasure; or 
‘‘(v) an official, agent, or employee of a person 
or entity described in clause (i), (ii), (iii), or (iv). 
‘‘(3) DISTRIBUTOR.—The term ‘distributor’ means a person 
or entity engaged in the distribution of drugs, biologics, or 
devices, including but not limited to manufacturers; repackers; 
common carriers; contract carriers; air carriers; own-label 
distributors; private-label distributors; jobbers; brokers; ware-
houses, and wholesale drug warehouses; independent wholesale 
drug traders; and retail pharmacies. 
‘‘(4) MANUFACTURER.—The term ‘manufacturer’ includes—
‘‘(A) a contractor or subcontractor of a manufacturer; 
‘‘(B) a supplier or licenser of any product, intellectual 
property, service, research tool, or component or other 
article used in the design, development, clinical testing, 
investigation, or manufacturing of a covered counter-
measure; and 
‘‘(C) any or all of the parents, subsidiaries, affiliates, 
successors, and assigns of a manufacturer. 
‘‘(5) PERSON.—The term ‘person’ includes an individual, 
partnership, corporation, association, entity, or public or private 
corporation, including a Federal, State, or local government 
agency or department. 
‘‘(6) PROGRAM
PLANNER.—The term ‘program planner’ 
means a State or local government, including an Indian tribe, 
a person employed by the State or local government, or other 
person who supervised or administered a program with respect 
to the administration, dispensing, distribution, provision, or 
use of a security countermeasure or a qualified pandemic or 
epidemic product, including a person who has established 
requirements, provided policy guidance, or supplied technical 
or scientific advice or assistance or provides a facility to admin-
ister or use a covered countermeasure in accordance with a 
declaration under subsection (b). 
‘‘(7) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—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
H. R. 2863—150
device (as such term is defined by section 201(h) of the Federal 
Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is—
‘‘(A)(i) a product manufactured, used, designed, devel-
oped, modified, licensed, or procured—
‘‘(I) to diagnose, mitigate, prevent, treat, or cure 
a pandemic or epidemic; or 
‘‘(II) to limit the harm such pandemic or epidemic 
might otherwise cause; or 
‘‘(ii) a product manufactured, used, designed, devel-
oped, modified, licensed, or procured to diagnose, mitigate, 
prevent, treat, or cure a serious or life-threatening disease 
or condition caused by a product described in clause (i); 
and 
‘‘(B)(i) approved or cleared under chapter V of the 
Federal Food, Drug, and Cosmetic Act or licensed under 
section 351 of this Act; 
‘‘(ii) the object of research for possible use as described 
by subparagraph (A) and is the subject of an exemption 
under section 505(i) or 520(g) of the Federal Food, Drug, 
and Cosmetic Act; or 
‘‘(iii) authorized for emergency use in accordance with 
section 564 of the Federal Food, Drug, and Cosmetic Act. 
‘‘(8) QUALIFIED PERSON.—The term ‘qualified person’, when 
used with respect to the administration or use of a covered 
countermeasure, means—
‘‘(A) a licensed health professional or other individual 
who is authorized to prescribe, administer, or dispense 
such countermeasures under the law of the State in which 
the countermeasure was prescribed, administered, or dis-
pensed; or 
‘‘(B) a person within a category of persons so identified 
in a declaration by the Secretary under subsection (b). 
‘‘(9) SECURITY
COUNTERMEASURE.—The term ‘security 
countermeasure’ has the meaning given such term in section 
319F–2(c)(1)(B). 
‘‘(10) SERIOUS PHYSICAL INJURY.—The term ‘serious phys-
ical injury’ means an injury that—
‘‘(A) is life threatening; 
‘‘(B) results in permanent impairment of a body func-
tion or permanent damage to a body structure; or 
‘‘(C) necessitates medical or surgical intervention to 
preclude permanent impairment of a body function or 
permanent damage to a body structure.’’. 
SEC. 3. COVERED COUNTERMEASURE PROCESS. 
Part B of title III of the Public Health Service Act is further 
amended by inserting after section 319F–3 (as added by section 
2) the following new section: 
‘‘SEC. 319F–4. COVERED COUNTERMEASURE PROCESS. 
‘‘(a) ESTABLISHMENT OF FUND.—Upon the issuance by the Sec-
retary of a declaration under section 319F–3(b), there is hereby 
established in the Treasury an emergency fund designated as the 
‘Covered Countermeasure Process Fund’ for purposes of providing 
timely, uniform, and adequate compensation to eligible individuals 
for covered injuries directly caused by the administration or use 
of a covered countermeasure pursuant to such declaration, which