Petition for Writ of Certiorari — Pomona Healthcare and Wellness Center, dba Park Avenue Healthcare and Wellness Center, Petitioner v. Brenda Thomas, Individually and as Heir and Successor in Interest to Larry Charles Jackson

Supreme Court briefSep 19, 2023

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APPENDIX

TABLE OF CONTENTS

Appendix A Memorandum in the United States

Court of Appeals for the Ninth Circuit

(June 21, 2023) . . . . . . . . . . . . . . . App. 1

Appendix B Civil Minutes for Order Granting

Plaintiffs’ Motion to Remand [13] and

Denying as Moot Defendants Motion

to Dismiss [9] in the United States

District Court for the Central District

of California

(March 22, 2022) . . . . . . . . . . . . . . App. 5

Appendix C Statutory Provisions Involved . . App. 16

42 U.S.C. § 247d-6d . . . . . . . . App. 16

42 U.S.C. § 247d-6e . . . . . . . . App. 45

App. 1

APPENDIX A

NOT FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

No. 22-55412

D.C. No. 2:22-cv-00179-SVW-PLA

[Filed June 21, 2023]

______________________________________

BRENDA THOMAS, individually and

)

as heir and successor in interest to

)

Larry Charles Jackson, Deceased,

)

Plaintiff-Appellee,

)

POMONA HEALTHCARE AND

)

WELLNESS CENTER, DBA Park

)

Avenue Healthcare and Wellness Center, )

)

Defendant-Appellant,

)

and

)

DOES, 1-50; 51-60,

)

Defendant.

)

______________________________________ )

App. 2

MEMORANDUM*

Appeal from the United States District Court

for the Central District of California

Stephen V. Wilson, District Judge, Presiding

Submitted June 20, 2023**

Before: WALLACE, O’SCANNLAIN, and SILVERMAN,

Circuit Judges.

Pomona Healthcare & Wellness Center, LLC

(“Pomona”) appeals from the district court’s order

remanding this case to state court for lack of federal

subject matter jurisdiction. Pomona argues that the

district court had three independent grounds for such

jurisdiction: federal officer removal, complete

preemption, and the presence of an embedded federal

question.

The district court did not have federal subject

matter jurisdiction under the federal officer removal

statute, 28 U.S.C. § 1442(a)(1), because Pomona’s

actions were not “taken pursuant to a federal officer’s

directions.” Saldana v. Glenhaven Healthcare LLC, 27

F.4th 679, 684 (9th Cir. 2022) (cleaned up). While

Pomona has demonstrated that, like the defendants in

Saldana, it was subject to federal laws and regulations

This disposition is not appropriate for publication and is not

precedent except as provided by Ninth Circuit Rule 36-3.

The panel unanimously concludes this case is suitable for

decision without oral argument. See Fed. R. App. P. 34(a)(2).

App. 3

throughout the COVID-19 pandemic, “simply

complying with a law or regulation is not enough to

bring a private person within the scope of the [federal

officer removal] statute.” Id. (cleaned up). Similarly,

recommendations, advice, and encouragement from

federal entities do not amount to the type of control

required for removal under the statute. See id. at 685.

The district court did not have federal subject

matter jurisdiction under the doctrine of complete

preemption because the Public Readiness and

Emergency Preparedness (PREP) Act, 42 U.S.C.

§§ 247d-6d, 247d-6e, is not a complete preemption

statute—that is, it is not one of those “rare” statutes

“where a federal statutory scheme is so comprehensive

that it entirely supplants state law causes of action.”

Saldana, 27 F.4th at 686 (cleaned up). While the PREP

Act may preempt some state-law claims, any such

conflict preemption would be an affirmative defense,

and would not create federal subject matter

jurisdiction. See id. at 688.

III

The district court did not have embedded federal

question jurisdiction because the state-law causes of

action in the complaint do not “necessarily” raise

“substantial” federal issues that are “actually disputed”

and “capable of resolution in federal court without

disrupting the federal-state balance approved by

Congress.” Id. at 688 (cleaned up). Although a federal

defense may be available under the PREP Act, “a

App. 4

federal defense is not a sufficient basis to find

embedded federal question jurisdiction.” Id.

In short, all of Pomona’s challenges are controlled

by Saldana. Pomona argues that Saldana was wrongly

decided, but cites no “clearly irreconcilable” intervening

authority permitting us to overrule it. Miller v.

Gammie, 335 F.3d 889, 900 (9th Cir. 2003) (en banc).

Accordingly, we apply Saldana.

AFFIRMED.

App. 5

APPENDIX B

UNITED STATES DISTRICT COURT

CENTRAL DISTRICT OF CALIFORNIA

Case No. 2:22-cv-00179-SVW-PLA

[Filed March 22, 2022]

Title Brenda Thomas v. Pomona Healthcare and

Wellness Center et al

JS-6

CIVIL MINUTES - GENERAL

Present: The Honorable STEPHEN V. WILSON, U.S.

DISTRICT JUDGE

Paul M. Cruz

N/A

Deputy Clerk

Court Reporter / Recorder

Attorneys Present for

Plaintiffs:

Attorneys Present for

Defendants:

N/A

Proceedings: ORDER GRANTING PLAINTIFFS’

MOTION TO REMAND [13] AND

DENYING AS MOOT DEFENDANTS

MOTION TO DISMISS [9].

Before the Court are two motions: Defendants’

motion to dismiss and Plaintiffs’ motion to remand to

state court. ECF Nos. 9, 13. For the below reasons, the

App. 6

motion remand to GRANTED, and the motion to

dismiss is DENIED as moot.

Background

A. Factual and Procedural Background

Plaintiff, the surviving daughter and successors in

interest to Decedent Larry Jackson, filed a complaint

against Defendant Pomona Healthcare & Wellness

Center, LLC, where Decedent lived prior to his death.

Compl. ¶¶ 1, 14-18.1

Decedent was a resident of Defendant’s skilled

nursing facility. Id. ¶ 18, 25. Decedent was in a

“compromised physical state” due to dementia and

hypertension. Id. ¶¶ 25-26. Plaintiff alleges that

Defendant failed to take adequate preventative

measures to stop the spread of covid-19, which led to

Decedent contracting covid-19 in August of 2020. Id.

¶¶ 27-28, 33. Decedent was transferred to the hospital

due to his severe symptoms, and ultimately died a few

weeks later. Id. ¶¶ 29-30.

Plaintiff filed this action in California state court

asserting state law claims for elder abuse, negligence,

and wrongful death. Id. ¶¶ 42-63. Defendants later

removed the action to this Court, Notice of Removal,

ECF No. 1, arguing that there is federal jurisdiction

because (1) Plaintiffs’ claims implicate embedded

federal questions; (2) the Public Readiness and

Emergency Preparedness Act (“PREP Act”) completely

The complaint was originally filed as Notice of Removal, Ex. A,

ECF No. 1-1.

App. 7

preempts Plaintiffs’ claims; and (3) Defendants qualify

as persons “acting under” federal officers within the

federal officer removal statute. Id. ¶¶ 11-12, 36-38, 44.

Defendants now seek dismissal based on the

immunity purportedly conferred by the PREP Act, Mot.

Dismiss 5-6, ECF No. 9, while Plaintiffs seek remand

to state court. Mot. Remand, ECF No. 13.

B. Legal Background

The PREP Act, passed in 2005, is invoked when the

Secretary of the Department of Health and Human

Services (“HHS”) issues a declaration determining that

a disease or other health condition constitutes an

ongoing public health emergency. 42 U.S.C. § 247d6d(b). The Secretary may then make a declaration,

“recommending ... the manufacture, testing,

development, distribution, administration, or use of one

or more covered countermeasures.” Id. The Secretary

issued a declaration for the ongoing covid-19 pandemic

on March 10, 2020, and has issued several subsequent

amendments thereto.

Once invoked, the PREP Act provides that “a

covered person shall be immune from suit and liability

under Federal and State law with respect to all claims

for loss caused by, arising out of, relating to, or

resulting from the administration to or the use by an

individual of a covered countermeasure.” 42 U.S.C.

§ 247d-6d(a)(1). “Covered countermeasures” under the

PREP Act include drugs, biological products, or devices

that are designed to diagnose, mitigate, prevent, or

treat harm from the public health emergency. Id.

§§ 247d-6d(i)(1), (7). The immunity afforded by the

App. 8

PREP Act is broad. It applies to “any claim for loss that

has a causal relationship with the administration to or

use by an individual of a covered countermeasure.” Id.

§ 247d-6d(a)(2)(B).

When its provisions are in effect, the PREP Act

preempts state laws that create different standards

regarding covered countermeasures. No state or

locality may establish or enforce any legal requirement

that is different from the PREP Act’s provisions or

relates to the use or administration of covered

countermeasures. 42 U.S.C. § 247d-6d(b)(8).

II.

Discussion

Federal courts operate under the presumption that

they do not have jurisdiction over state-law causes of

action. See Kokkonen v. Guardian Life Ins. Co., 511

U.S. 375, 377 (1994). “The defendant bears the burden

of establishing that removal is proper” and removal

statutes are “strictly construed against removal

jurisdiction.” Provincial Gov’t of Marinduque v. Placer

Dome, Inc., 582 F.3d 1083, 1087 (9th Cir. 2009); see

also Gaus v. Miles, Inc., 980 F.2d 564, 566 (9th Cir.

1992) (“[J]urisdiction must be rejected if there is any

doubt as to the right of removal.”).

Defendants offer three reasons that federal

jurisdiction exists here: (1) Plaintiff’s claims raise

embedded federal issues; (2) the PREP Act is a

complete preemption statute; and (3) the federal officer

removal statute applies. Notice of Removal ¶¶ 11-12,

36-38, 44. These same arguments have been almost

uniformly rejected in dozens of cases in this district to

have considered the issue. And most significantly, the

App. 9

Ninth Circuit has also recently rejected these exact

same arguments in a virtually identical case, holding

that there was no basis for federal jurisdiction and that

remand was proper. Saldana v. Glenhaven Healthcare

LLC, -- F.4th --, 2022 WL 518989, *6 (9th Cir. Feb. 22,

2022).

A. Embedded Federal Issues

The presence of federal question jurisdiction is

generally governed by the “well-pleaded complaint

rule,” which provides that federal jurisdiction exists

only when a federal question is presented on the face of

the plaintiff’s properly pleaded complaint. See

Caterpillar Inc. v. Williams, 482 U.S. 386, 392 (1987).

This rule makes a plaintiff the master of his complaint:

it allows him to avoid federal jurisdiction by relying

exclusively on state law. It is “settled law that a case

may not be removed to federal court on the basis of a

federal defense, including the defense of preemption,

even if the defense is anticipated in the plaintiff’s

complaint, and even if both parties admit that the

defense is the only question truly at issue in the case.”

Franchise Tax Bd. of State of Cal. v. Constr. Laborers

Vacation Tr. for S. Cal., 463 U.S. 1, 13-14 (1983).

However, under Grable & Sons Metal Products, Inc.

v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), even

claims pled as violations of state law claims can invoke

federal question jurisdiction if they “necessarily raise

a stated federal issue, actually disputed and

substantial, which a federal forum may entertain

without disturbing any congressionally approved

balance of federal and state judicial responsibilities.”

Id. at 314.

App. 10

Defendants contend that federal question

jurisdiction exists because Plaintiffs’ claims raise a

“substantial federal issue” – the extent to which PREP

Act immunity applies to Defendants’ conduct. Notice of

Removal ¶ 36. Defendant points to the HHS Advisory

Opinion (“AO”) 21-01, see id., which characterizes

covid-19 as a global challenge that requires a whole-ofnation response and implicates substantial federal

legal and policy issues within the meaning of Grable.

Notice of Removal, Ex. D at 5.

However, the federal issue raised by Defendants –

PREP Act immunity – relates to a defense, rather than

the claims Plaintiffs allege. “As such, the federal issue

is not necessarily raised.” Stone v. Long Beach

Healthcare Ctr., LLC, 2021 WL 1163572, at *7 (C.D.

Cal. Mar. 26, 2021); see also Padilla v. Brookfield

Healthcare Ctr., 2021 WL 1549689, at *6 (C.D. Cal.

Apr. 19, 2021); (“immunity under the PREP Act is a

defense, not a necessary aspect of Plaintiffs’ state law

claims”); Thomas v. Century Villa Inc., 2021 WL

2400970, at *6 (C.D. Cal. June 10, 2021) (“the PREP

Act merely provides [Defendant] with a potential

affirmative defense to Plaintiffs’ claims” and therefore

does not confer federal question jurisdiction).

Defendants cannot remove this action to federal court

based on a federal defense, including the defense of

preemption. See Saldana, 2022 WL 518989, at *6;

Franchise Tax Bd., 463 U.S. at 13-14.

This conclusion is not changed by HHS’s

statements. Saldana considered such opinions –

including AO 21-01 specifically – and made clear that

HHS declarations and advisory opinions are not final

App. 11

agency interpretations entitled to any deference. 2022

WL 518989, at *6. Indeed, as many other courts in this

district have noted, the HHS opinions even have

minimal persuasive value, given their conclusory

invocation of Grable without supporting legal analysis.

See, e.g., Estate of McCalebb v. AG Lynwood, LLC, 2021

WL 911951, *3 (C.D. Cal. Mar. 1, 2021); Thomas, 2021

WL 2400970, at *6; Acra v. Cal. Magnolia Convalescent

Hosp., Inc., 2021 WL 2769041, at *7 (C.D. Cal. July 1,

2021); Estate of Heim v. 1495 Cameron Avenue, LLC,

2021 WL 3630374, at *4, n. 2 (C.D. Cal. Aug. 17, 2021).

Thus, Plaintiffs’ claims do not raise an embedded

federal issue that would support jurisdiction.

B. Complete Preemption

The doctrine of “complete preemption” is a narrow

exception to the well-pleaded complaint rule. The

United States Supreme Court has concluded that the

preemptive force of some federal statutes is so strong

that they “completely pre-empt” an area of state law.

See Metro. Life Ins. Co. v. Taylor, 481 U.S. 58, 63-64

(1987). When complete preemption applies, the statelaw nature of the plaintiff’s claim is “displace[d]” and

the claim is considered “purely a creature of federal

law.” Franchise Tax Bd., 463 U.S. at 23-24.

Complete preemption is rare. See Hansen v. Grp.

Health Coop., 902 F.3d 1051, 1057 (9th Cir. 2018). The

Supreme Court has identified only three statutes that

completely preempt state law. City of Oakland v. BP

PLC, 969 F.3d 895, 905-06 (9th Cir. 2020). The Ninth

Circuit has prescribed a two-part test: complete

preemption “exists when Congress: (1) intended to

App. 12

displace a state-law cause of action, and (2) provided a

substitute cause of action.” City of Oakland, 969 F.3d

at 906.

Defendant argues that the PREP Act completely

preempts Plaintiffs’ claims, all of which are state law

causes of action. See Notice of Removal ¶ 35. However,

in Saldana, the Ninth Circuit explicitly held that

“under this court’s two-part test, the PREP Act is not

a complete preemption statute.” 2022 WL 518989, at

*5.

For one, nothing suggests that Congress intended

the PREP Act to displace state law claims. Id. At its

core, the PREP Act is an immunity statute – Congress

intended to provide a defense for those covered by its

provisions from state law claims, but that does not

imply that Congress intended to convert those claims

into federal ones and bar them from being heard in

state court in the first place. See id; Estate of Jenkins

v. Beverly Hills Senior Care Facility, Inc., 2021 WL

3563545, *4 (C.D. Cal. Aug. 12, 2021); Heim, 2021 WL

3630374 at *4.

Second, the PREP Act does not provide a substitute

cause of action. Saldana, 2022 WL 518989, at *5.

Complete preemption “rests on the theory that any

state claim within its reach is transfo1med into a

federal claim”. McCalebb, 2021 WL 911951 at*4

(cleaned up) (internal quotations and citations

omitted). Thus, the substitute cause of action must be

a federal one capable of being pursued in a federal

forum. See Moore-Thomas v. Alaska Airlines, Inc., 553

F.3d 1241, 1245-46 (9th Cir. 2009). Yet, other than a

narrow exception for willful misconduct, the PREP Act

App. 13

provides only an administrative claims procedure that

is not subject to judicial review. 42 U.S.C. §§ 247d6e(b)(5)(C). Complete preemption is a doctrine of

federal jurisdiction – thus it logically cannot be

triggered by a substitute procedure that explicitly

prohibits the very exercise of federal jurisdiction. See

McCalebb 2021 WL 911951 at *4.

Defendant relies on two authorities in support of its

argument for complete preemption. First, Defendant

again points to the HHS AO 21-01, see Notice of

Removal ¶ 30-32, which posits that the PREP Act is a

complete preemption statute. Notice of Removal, Ex. D

at 2-4. However, as discussed above, see Section II.A,

supra, this advisory opinion is not entitled to any

doctrine of deference. Saldana, 2022 WL 518989, at *5.

Nor is it even persuasive because of its lack of legal

support for its conclusion. See also, e.g., Padilla, 2021

WL 1549689, at *4-5; Acra, 2021 WL 2769041 at *5;

Stone, 2021 WL 1163572, at *6.

Second, Defendant highlights Garcia v. Welltower

OpCo Grp. LLC, see Notice of Removal ¶ 33, in which

the court concluded that the PREP Act completely

preempts state law. 2021 WL 492581, at *7 (C.D. Cal.

Feb. 10, 2021). However, Garcia was clearly abrogated

on this issue by the Ninth Circuit in Saldana. See 2022

WL 518989, at *5.2

Thus, under explicit binding authority, the PREP

Act is not a complete preemption statute. Id.

Defendant filed its notice of removal, in which it cited to Garcia,

before the Ninth Circuit rendered its opinion in Saldana.

App. 14

C. Federal Officer Removal

Title 28 U.S.C. § 1442(a)(1) provides for the removal

to federal court of state court actions against “[t]he

United States or any agency thereof or any officer ( or

any person acting under that officer).” While the

grounds for removal ordinarily must be evident from

the face of the plaintiff’s well-pleaded complaint, under

§ 1442, cases can be removed on the basis of a

“colorable federal defense.” Jefferson County, Ala. v.

Acker, 527 U.S. 423, 431 (1999).

Even private parties can exercise federal officer

removal when they can show that they were a “person

acting under” a federal officer. See Durham v. Lockheed

Martin Corp., 445 F.3d 1247, 1251 (9th Cir. 2006) To do

so, a party must demonstrate that “(a) it is a person

within the meaning of the statute; (b) there is a causal

nexus between its actions, taken pursuant to a federal

officer’s directions, and plaintiff’s claims; and (c) it can

assert a ‘colorable federal defense.”’ Stirling v.

Minasian, 955 F.3d 795, 800 (9th Cir. 2020).

Defendant argues that it was acting at the specific

direction of federal authorities to address the on-going

federal effort and national state of emergency to

contain the COVID-19 pandemic and prevent the

spread of the virus. Notice of Removal, ¶¶ 44-53.

Defendants asserts they acted pursuant to detailed

directives issued by various government agencies. Id.

¶¶ 48-50.

However, “[a] private firm’s compliance (or

noncompliance) with federal laws, rules, and

regulations does not by itself fall within the scope of

App. 15

the statutory phrase ‘acting under’ a federal ‘official.”’

Watson v. Philip Morris Cos., Inc., 551 U.S. 142, 147,

153 (2007). “And that is so even if the regulation is

highly detailed and even if the private firm’s activities

are highly supervised and monitored.” Id. at 153.

Accordingly, as Saldana concluded, “[a]ll that

[defendant] has demonstrated is that it operated as a

private entity subject to government regulations, and

that during the covid-19 pandemic it received

additional regulations and recommendations from

federal agencies. Thus, [defendant] was not ‘acting

under’ a federal officer or agency as contemplated by

the federal officer removal statute.” 2022 WL 518989,

at *4.

As in Saldana, the mere fact that Defendant

followed government regulations – even if exactingly

detailed – does not provide a basis for federal officer

removal here. See id.

III.

Conclusion

For the foregoing reasons, Plaintiffs’ motion to

remand is GRANTED; Defendant’s motion to dismiss

is DENIED as moot. This case shall be remanded back

to the Superior Court of California, County of Los

Angeles.

IT IS SO ORDERED.

App. 16

APPENDIX C

STATUTORY PROVISIONS INVOLVED

United States Code

Title 42. The Public Health and Welfare

42 U.S.C. § 247d-6d

§ 247d-6d. Targeted liability protections for

pandemic and epidemic products and security

countermeasures

(a) Liability protections

(1) In general

Subject to the other provisions of this section, a

covered person shall be immune from suit and

liability under Federal and State law with respect

to all claims for loss caused by, arising out of,

relating to, or resulting from the administration to

or the use by an individual of a covered

countermeasure if a declaration under subsection

(b) has been issued with respect to such

countermeasure.

(2) Scope of claims for loss

(A) Loss

For purposes of this section, the term “loss”

means any type of loss, including—

(i) death;

App. 17

(ii) physical, mental, or emotional injury,

illness, disability, or condition;

(iii) fear of physical, mental, or emotional

injury, illness, disability, or condition,

including any need for medical monitoring;

and

(iv) loss of or damage to property, including

business interruption loss.

Each of clauses (i) through (iv) applies

without regard to the date of the occurrence,

presentation, or discovery of the loss

described in the clause.

(B) Scope

The immunity under paragraph (1) applies to

any claim for loss that has a causal relationship

with the administration to or use by an

individual of a covered countermeasure,

including a causal relationship with the design,

development, clinical testing or investigation,

manufacture, labeling, distribution, formulation,

packaging, marketing, promotion, sale,

purchase, donation, dispensing, prescribing,

administration, licensing, or use of such

countermeasure.

(3) Certain conditions

Subject to the other provisions of this section,

immunity under paragraph (1) with respect to a

covered countermeasure applies only if—

App. 18

(A) the countermeasure was administered or

used during the effective period of the

declaration that was issued under subsection (b)

with respect to the countermeasure;

(B) the countermeasure was administered or

used for the category or categories of diseases,

health conditions, or threats to health specified

in the declaration; and

who is a program planner or qualified person

with respect to the administration or use of the

countermeasure, the countermeasure was

administered to or used by an individual who—

(i) was in a population specified by the

declaration; and

(ii) was at the time of administration

physically present in a geographic area

specified by the declaration or had a

connection to such area specified in the

declaration.

(4) Applicability of certain conditions

With respect to immunity under paragraph (1) and

subject to the other provisions of this section:

(A) In the case of a covered person who is a

manufacturer or distributor of the covered

countermeasure involved, the immunity applies

without regard to whether such countermeasure

was administered to or used by an individual in

App. 19

accordance with the conditions described in

paragraph (3)(C).

(B) In the case of a covered person who is a

program planner or qualified person with

respect to the administration or use of the

covered countermeasure, the scope of immunity

includes circumstances in which the

countermeasure was administered to or used by

an individual in circumstances in which the

covered person reasonably could have believed

that the countermeasure was administered or

used in accordance with the conditions described

in paragraph (3)(C).

(5) Effect of distribution method

The provisions of this section apply to a covered

countermeasure regardless of whether such

countermeasure is obtained by donation,

commercial sale, or any other means of distribution,

except to the extent that, under paragraph (2)(E) of

subsection (b), the declaration under such

subsection provides that subsection (a) applies only

to covered countermeasures obtained through a

particular means of distribution.

(6) Rebuttable presumption

For purposes of paragraph (1), there shall be a

rebuttable presumption that any administration or

use, during the effective period of the emergency

declaration by the Secretary under subsection (b), of

a covered countermeasure shall have been for the

category or categories of diseases, health conditions,

App. 20

or threats to health with respect to which such

declaration was issued.

(b) Declaration by Secretary

(1) Authority to issue declaration

Subject to paragraph (2), if the Secretary makes a

determination that a disease or other health

condition or other threat to health constitutes a

public health emergency, or that there is a credible

risk that the disease, condition, or threat may in the

future constitute such an emergency, the Secretary

may make a declaration, through publication in the

Federal Register, recommending, under conditions

as the Secretary may specify, the manufacture,

testing, development, distribution, administration,

or use of one or more covered countermeasures, and

stating that subsection (a) is in effect with respect

to the activities so recommended.

(2) Contents

In issuing a declaration under paragraph (1), the

Secretary shall identify, for each covered

countermeasure specified in the declaration—

(A) the category or categories of diseases, health

conditions, or threats to health for which the

Secretary recommends the administration or use

of the countermeasure;

(B) the period or periods during which, including

as modified by paragraph (3), subsection (a) is in

effect, which period or periods may be

designated by dates, or by milestones or other

App. 21

description of events, including factors specified

in paragraph (6);

for which subsection (a) is in effect with respect

to the administration or use of the

countermeasure (which may be a specification

that such subsection applies without geographic

limitation to all individuals);

(D) the geographic area or areas for which

subsection (a) is in effect with respect to the

administration or use of the countermeasure

(which may be a specification that such

subsection applies without geographic

limitation), including, with respect to

individuals in the populations identified under

subparagraph (C), a specification, as determined

appropriate by the Secretary, of whether the

declaration applies only to individuals physically

present in such areas or whether in addition the

declaration applies to individuals who have a

connection to such areas, which connection is

described in the declaration; and

(E) whether subsection (a) is effective only to a

particular means of distribution as provided in

subsection (a)(5) for obtaining the

countermeasure, and if so, the particular means

to which such subsection is effective.

(3) Effective period of declaration

(A) Flexibility of period

App. 22

The Secretary may, in describing periods under

paragraph (2)(B), have different periods for

different covered persons to address different

logistical, practical or other differences in

responsibilities.

(B) Additional time to be specified

In each declaration under paragraph (1), the

Secretary, after consulting, to the extent the

Secretary deems appropriate, with the

manufacturer of the covered countermeasure,

shall also specify a date that is after the ending

date specified under paragraph (2)(B) and that

allows what the Secretary determines is—

(i) a reasonable period for the manufacturer

to arrange for disposition of the covered

countermeasure, including the return of such

product to the manufacturer; and

(ii) a reasonable period for covered persons to

take such other actions as may be

appropriate to limit administration or use of

the covered countermeasure.

national stockpile countermeasures

With respect to a covered countermeasure that

is in the stockpile under section 247d-6b of this

title, if such countermeasure was the subject of

a declaration under paragraph (1) at the time

that it was obtained for the stockpile, the

effective period of such declaration shall include

a period when the countermeasure is

App. 23

administered or used pursuant to a distribution

or release from the stockpile.

(4) Amendments to declaration

The Secretary may through publication in the

Federal Register amend any portion of a declaration

under paragraph (1). Such an amendment shall not

retroactively limit the applicability of subsection (a)

with respect to the administration or use of the

covered countermeasure involved.

(5) Certain disclosures

In publishing a declaration under paragraph (1) in

the Federal Register, the Secretary is not required

to disclose any matter described in section 552(b) of

Title 5.

(6) Factors to be considered

In deciding whether and under what circumstances

or conditions to issue a declaration under paragraph

(1) with respect to a covered countermeasure, the

Secretary shall consider the desirability of

encouraging the design, development, clinical

testing or investigation, manufacture, labeling,

distribution, formulation, packaging, marketing,

promotion, sale, purchase, donation, dispensing,

prescribing, administration, licensing, and use of

such countermeasure.

(7) Judicial review

No court of the United States, or of any State, shall

have subject matter jurisdiction to review, whether

App. 24

by mandamus or otherwise, any action by the

Secretary under this subsection.

(8) Preemption of State law

During the effective period of a declaration under

subsection (b), or at any time with respect to

conduct undertaken in accordance with such

declaration, no State or political subdivision of a

State may establish, enforce, or continue in effect

with respect to a covered countermeasure any

provision of law or legal requirement that—

(A) is different from, or is in conflict with, any

requirement applicable under this section; and

(B) relates to the design, development, clinical

testing or investigation, formulation,

manufacture, distribution, sale, donation,

purchase, marketing, promotion, packaging,

labeling, licensing, use, any other aspect of

safety or efficacy, or the prescribing, dispensing,

or administration by qualified persons of the

covered countermeasure, or to any matter

included in a requirement applicable to the

covered countermeasure under this section or

any other provision of this chapter, or under the

Federal Food, Drug, and Cosmetic Act.

(9) Report to Congress

Within 30 days after making a declaration under

paragraph (1), the Secretary shall submit to the

appropriate committees of the Congress a report

that provides an explanation of the reasons for

issuing the declaration and the reasons underlying

App. 25

the determinations of the Secretary with respect to

paragraph (2). Within 30 days after making an

amendment under paragraph (4), the Secretary

shall submit to such committees a report that

provides the reasons underlying the determination

of the Secretary to make the amendment.

(1) Definition

(A) In general

Except as the meaning of such term is further

restricted pursuant to paragraph (2), the term

“willful misconduct” shall, for purposes of

subsection (d), denote an act or omission that is

taken—

(i) intentionally to achieve a wrongful

purpose;

(ii) knowingly without legal or factual

justification; and

(iii) in disregard of a known or obvious risk

that is so great as to make it highly probable

that the harm will outweigh the benefit.

(B) Rule of construction

The criterion stated in subparagraph (A) shall be

construed as establishing a standard for liability

that is more stringent than a standard of

negligence in any form or recklessness.

App. 26

(2) Authority to promulgate regulatory definition

(A) In general

The Secretary, in consultation with the Attorney

General, shall promulgate regulations, which

may be promulgated through interim final rules,

that further restrict the scope of actions or

omissions by a covered person that may qualify

as “willful misconduct” for purposes of

subsection (d).

(B) Factors to be considered

In promulgating the regulations under this

paragraph, the Secretary, in consultation with

the Attorney General, shall consider the need to

define the scope of permissible civil actions

under subsection (d) in a way that will not

adversely affect the public health.

The regulations under this paragraph may

specify the temporal effect that they shall be

given for purposes of subsection (d).

(D) Initial rulemaking

Within 180 days after December 30, 2005, the

Secretary, in consultation with the Attorney

General, shall commence and complete an initial

rulemaking process under this paragraph.

(3) Proof of willful misconduct

In an action under subsection (d), the plaintiff shall

have the burden of proving by clear and convincing

App. 27

evidence willful misconduct by each covered person

sued and that such willful misconduct caused death

or serious physical injury.

(4) Defense for acts or omissions taken pursuant to

Secretary’s declaration

Notwithstanding any other provision of law, a

program planner or qualified person shall not have

engaged in “willful misconduct” as a matter of law

where such program planner or qualified person

acted consistent with applicable directions,

guidelines, or recommendations by the Secretary

regarding the administration or use of a covered

countermeasure that is specified in the declaration

under subsection (b), provided either the Secretary,

or a State or local health authority, was provided

with notice of information regarding serious

physical injury or death from the administration or

use of a covered countermeasure that is material to

the plaintiff’s alleged loss within 7 days of the

actual discovery of such information by such

program planner or qualified person.

(5) Exclusion for regulated activity of manufacturer

or distributor

(A) In general

If an act or omission by a manufacturer or

distributor with respect to a covered

countermeasure, which act or omission is alleged

under subsection (e)(3)(A) to constitute willful

misconduct, is subject to regulation by this

chapter or by the Federal Food, Drug, and

Cosmetic Act, such act or omission shall not

App. 28

constitute “willful misconduct” for purposes of

subsection (d) if—

(i) neither the Secretary nor the Attorney

General has initiated an enforcement action

with respect to such act or omission; or

(ii) such an enforcement action has been

initiated and the action has been terminated

or finally resolved without a covered remedy.

Any action or proceeding under subsection

(d) shall be stayed during the pendency of

such an enforcement action.

(B) Definitions

For purposes of this paragraph, the following

terms have the following meanings:

(i) Enforcement action

The term “enforcement action” means a

criminal prosecution, an action seeking an

injunction, a seizure action, a civil monetary

proceeding based on willful misconduct, a

mandatory recall of a product because

voluntary recall was refused, a proceeding to

compel repair or replacement of a product, a

termination of an exemption under section

505(i) or 520(g) of the Federal Food, Drug,

and Cosmetic Act, a debarment proceeding,

an investigator disqualification proceeding

where an investigator is an employee or

agent of the manufacturer, a revocation,

based on willful misconduct, of an

App. 29

authorization under section 564 of such Act,

or a suspension or withdrawal, based on

willful misconduct, of an approval or

clearance under chapter V of such Act or of a

licensure under section 262 of this title.

(ii) Covered remedy

The term “covered remedy” means an

outcome—

(I) that is a criminal conviction, an

injunction, or a condemnation, a civil

monetary payment, a product recall, a

repair or replacement of a product, a

termination of an exemption under

section 505(i) or 520(g) of the Federal

Food, Drug, and Cosmetic Act, a

debarment, an investigator disqualification,

a revocation of an authorization under

section 564 of such Act, or a suspension or

withdrawal of an approval or clearance

under chapter 51 of such Act or of a

licensure under section 262 of this title;

and

(II) that results from a final

determination by a court or from a final

agency action.

(iii) Final

The terms “final” and “finally”—

(I) with respect to a court determination,

or to a final resolution of an enforcement

App. 30

action that is a court determination,

mean a judgment from which an appeal of

right cannot be taken or a voluntary or

stipulated dismissal; and

(II) with respect to an agency action, or to

a final resolution of an enforcement action

that is an agency action, mean an order

that is not subject to further review

within the agency and that has not been

reversed, vacated, enjoined, or otherwise

nullified by a final court determination or

a voluntary or stipulated dismissal.

(i) In general

Nothing in

construed—

this

paragraph

shall

(I) to affect the interpretation of any

provision of the Federal Food, Drug, and

Cosmetic Act, of this chapter, or of any

other applicable statute or regulation; or

(II) to impair, delay, alter, or affect the

authority, including the enforcement

discretion, of the United States, of the

Secretary, of the Attorney General, or of

any other official with respect to any

administrative or court proceeding under

this chapter, under the Federal Food,

Drug, and Cosmetic Act, under Title 18,

or under any other applicable statute or

regulation.

App. 31

(ii) Mandatory recalls

A mandatory recall called for in the declaration

is not a Food and Drug Administration

enforcement action.

(d) Exception to immunity of covered persons

(1) In general

Subject to subsection (f), the sole exception to the

immunity from suit and liability of covered persons

set forth in subsection (a) shall be for an exclusive

Federal cause of action against a covered person for

death or serious physical injury proximately caused

by willful misconduct, as defined pursuant to

subsection (c), by such covered person. For purposes

of section 2679(b)(2)(B) of Title 28, such a cause of

action is not an action brought for violation of a

statute of the United States under which an action

against an individual is otherwise authorized.

(2) Persons who can sue

An action under this subsection may be brought for

wrongful death or serious physical injury by any

person who suffers such injury or by any

representative of such a person.

(e) Procedures for suit

(1) Exclusive Federal jurisdiction

Any action under subsection (d) shall be filed and

maintained only in the United States District Court

for the District of Columbia.

App. 32

(2) Governing law

The substantive law for decision in an action under

subsection (d) shall be derived from the law,

including choice of law principles, of the State in

which the alleged willful misconduct occurred,

unless such law is inconsistent with or preempted

by Federal law, including provisions of this section.

(3) Pleading with particularity

In an action under subsection (d), the complaint

shall plead with particularity each element of the

plaintiff’s claim, including—

(A) each act or omission, by each covered person

sued, that is alleged to constitute willful

misconduct relating to the covered

countermeasure administered to or used by the

person on whose behalf the complaint was filed;

(B) facts supporting the allegation that such

alleged willful misconduct proximately caused

the injury claimed; and

person on whose behalf the complaint was filed

suffered death or serious physical injury.

(4) Verification, certification, and medical records

(A) In general

In an action under subsection (d), the plaintiff

shall verify the complaint in the manner stated

in subparagraph (B) and shall file with the

complaint the materials described in

App. 33

subparagraph (C). A complaint that does not

substantially comply with subparagraphs (B)

and (C) shall not be accepted for filing and shall

not stop the running of the statute of

limitations.

(B) Verification requirement

(i) In general

The complaint shall include a verification,

made by affidavit of the plaintiff under oath,

stating that the pleading is true to the

knowledge of the deponent, except as to

matters specifically identified as being

alleged on information and belief, and that as

to those matters the plaintiff believes it to be

true.

(ii) Identification of matters alleged upon

information and belief

Any matter that is not specifically identified

as being alleged upon the information and

belief of the plaintiff, shall be regarded for all

purposes, including a criminal prosecution,

as having been made upon the knowledge of

the plaintiff.

In an action under subsection (d), the plaintiff

shall file with the complaint—

(i) an affidavit, by a physician who did not

treat the person on whose behalf the

complaint was filed, certifying, and

App. 34

explaining the basis for such physician’s

belief, that such person suffered the serious

physical injury or death alleged in the

complaint and that such injury or death was

proximately caused by the administration or

use of a covered countermeasure; and

(ii) certified medical records documenting

such injury or death and such proximate

causal connection.

(5) Three-judge court

Any action under subsection (d) shall be assigned

initially to a panel of three judges. Such panel shall

have jurisdiction over such action for purposes of

considering motions to dismiss, motions for

summary judgment, and matters related thereto. If

such panel has denied such motions, or if the time

for filing such motions has expired, such panel shall

refer the action to the chief judge for assignment for

further proceedings, including any trial. Section

1253 of Title 28 and paragraph (3) of subsection (b)

of section 2284 of Title 28 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;

App. 35

(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

interlocutory 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

App. 36

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 plaintiff 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).

For purposes 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

App. 37

(iv) any other publicly or privately funded

program.

(8) Noneconomic damages

In an action under subsection (d), any noneconomic

damages may be awarded only in an amount

directly proportional to the percentage of

responsibility of a defendant for the harm to the

plaintiff. For purposes of this paragraph, the term

“noneconomic damages” means damages for losses

for physical and emotional pain, suffering,

inconvenience, physical impairment, mental

anguish, disfigurement, loss of enjoyment of life,

loss of society and companionship, 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 responsible 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,

App. 38

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 jurisdiction 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 (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.

App. 39

(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 subchapter XIX of this

chapter.

(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 247d-6b(c)(1)(B) of this title);

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 262(i)

of this title), 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, 564A, or 564B of the Federal Food,

Drug, and Cosmetic Act; or

(D) a respiratory protective device that is

approved by the National Institute for

Occupational Safety and Health under part 84 of

App. 40

title 42, Code of Federal Regulations (or any

successor regulations), and that the Secretary

determines to be a priority for use during a

public health emergency declared under section

247d of this title.

(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

countermeasure;

planner

such

(iv) a qualified person who prescribed,

administered, 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

App. 41

distributors; jobbers; brokers; warehouses, and

wholesale drug warehouses; independent wholesale

drug traders; and retail pharmacies.

(4) Manufacturer

The term “manufacturer” includes—

(A) a contractor

manufacturer;

subcontractor

(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 countermeasure; and

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

App. 42

product, including a person who has established

requirements, provided policy guidance, or supplied

technical or scientific advice or assistance or

provides a facility to administer 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 262(i) of this title), 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—

(A)

(i) a product manufactured, used, designed,

developed, 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;

(ii) a product manufactured, used, designed,

developed, 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); or

App. 43

(iii) a product or technology intended to

enhance the use or effect of a drug, biological

product, or device described in clause (i) or

(ii); and

(B)

(i) approved or cleared under chapter V of the

Federal Food, Drug, and Cosmetic Act or

licensed under section 262 of this title;

(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, 564A, or 564B 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 dispensed; or

(B) a person within a category of persons so

identified in a declaration by the Secretary

under subsection (b).

App. 44

(9) Security countermeasure

The term “security countermeasure” has the

meaning given such term in section 247d-6b(c)(1)(B)

of this title.

(10) Serious physical injury

The term “serious physical injury” means an injury

that—

(A) is life threatening;

(B) results in permanent impairment of a body

function or permanent damage to a body

structure; or

to preclude permanent impairment of a body

function or permanent damage to a body

structure.

App. 45

United States Code

Title 42. The Public Health and Welfare

42 U.S.C. § 247d-6e

§ 247d-6e. Covered countermeasure process

(a) Establishment of Fund

Upon the issuance by the Secretary of a declaration

under section 247d-6d(b) of this title, 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 Fund shall consist of such amounts

designated as emergency appropriations under section

402 of H. Con. Res. 95 of the 109th Congress, this

emergency designation shall remain in effect through

October 1, 2006.

(b) Payment of compensation

(1) In general

If the Secretary issues a declaration under 247d6d(b) of this title, the Secretary shall, after amounts

have by law been provided for the Fund under

subsection (a), provide compensation to an eligible

individual for a covered injury directly caused by

the administration or use of a covered

countermeasure pursuant to such declaration.

App. 46

(2) Elements of compensation

The compensation that shall be provided pursuant

to paragraph (1) shall have the same elements, and

be in the same amount, as is prescribed by sections

239c, 239d, and 239e of this title in the case of

certain individuals injured as a result of

administration of certain countermeasures against

smallpox, except that section 239e(a)(2)(B) of this

title shall not apply.

(3) Rule of construction

Neither reasonable and necessary medical benefits

nor lifetime total benefits for lost employment

income due to permanent and total disability shall

be limited by section 239e of this title.

(4) Determination of eligibility and compensation

Except as provided in this section, the procedures

for determining, and for reviewing a determination

of, whether an individual is an eligible individual,

whether such individual has sustained a covered

injury, whether compensation may be available

under this section, and the amount of such

compensation shall be those stated in section 239a

of this title (other than in subsection (d)(2) of such

section), in regulations issued pursuant to that

section, and in such additional or alternate

regulations as the Secretary may promulgate for

purposes of this section. In making determinations

under this section, other than those described in

paragraph (5)(A) as to the direct causation of a

covered injury, the Secretary may only make such

App. 47

determination based on compelling, reliable, valid,

medical and scientific evidence.

(5) Covered countermeasure injury table

(A) In general

The Secretary shall by regulation establish a

table identifying covered injuries that shall be

presumed to be directly caused by the

administration or use of a covered

countermeasure and the time period in which

the first symptom or manifestation of onset of

each such adverse effect must manifest in order

for such presumption to apply. The Secretary

may only identify such covered injuries, for

purpose of inclusion on the table, where the

Secretary determines, based on compelling,

reliable, valid, medical and scientific evidence

that administration or use of the covered

countermeasure directly caused such covered

injury.

(B) Amendments

The provisions of section 239b of this title (other

than a provision of subsection (a)(2) of such

section that relates to accidental vaccinia

inoculation) shall apply to the table established

under this section.

No court of the United States, or of any State,

shall have subject matter jurisdiction to review,

App. 48

whether by mandamus or otherwise, any action

by the Secretary under this paragraph.

(6) Meanings of terms

In applying sections 239a, 239b, 239c, 239d, and

239e of this title for purposes of this section—

(A) the terms “vaccine” and “smallpox vaccine”

shall be deemed to mean a covered

countermeasure;

(B) the terms “smallpox vaccine injury table”

and “table established under section 239b of this

title” shall be deemed to refer to the table

established under paragraph (4); and

the meanings given to such terms by this

section.

The Secretary shall ensure that a State, local, or

Department of Health and Human Services plan to

administer or use a covered countermeasure is

consistent with any declaration under 247d-6d of this

title and any applicable guidelines of the Centers for

Disease Control and Prevention and that potential

participants are educated with respect to

contraindications, the voluntary nature of the program,

and the availability of potential benefits and

compensation under this part.

App. 49

(d) Exhaustion; exclusivity; election

(1) Exhaustion

Subject to paragraph (5), a covered individual may

not bring a civil action under section 247d-6d(d) of

this title against a covered person (as such term is

defined in section 247d-6d(i)(2) of this title) unless

such individual has exhausted such remedies as are

available under subsection (a), except that if

amounts have not by law been provided for the

Fund under subsection (a), or if the Secretary fails

to make a final determination on a request for

benefits or compensation filed in accordance with

the requirements of this section within 240 days

after such request was filed, the individual may

seek any remedy that may be available under

section 247d-6d(d) of this title.

(2) Tolling of statute of limitations

The time limit for filing a civil action under section

247d-6d(d) of this title for an injury or death shall

be tolled during the pendency of a claim for

compensation under subsection (a).

(3) Rule of construction

This section shall not be construed as superseding

or otherwise affecting the application of a

requirement, under chapter 171 of Title 28, to

exhaust administrative remedies.

(4) Exclusivity

The remedy provided by subsection (a) shall be

exclusive of any other civil action or proceeding for

App. 50

any claim or suit this section encompasses, except

for a proceeding under section 247d-6d of this title.

(5) Election

If under subsection (a) the Secretary determines

that a covered individual qualifies for

compensation, the individual has an election to

accept the compensation or to bring an action under

section 247d-6d(d) of this title. If such individual

elects to accept the compensation, the individual

may not bring such an action.

(e) Definitions

For purposes of this section, the following terms shall

have the following meanings:

(1) Covered countermeasure

The term “covered countermeasure” has the

meaning given such term in section 247d-6d of this

title.

(2) Covered individual

The term “covered individual”, with respect to

administration or use of a covered countermeasure

pursuant to a declaration, means an individual—

(A) who is in a population specified in such

declaration, and with respect to whom the

administration or use of the covered

countermeasure satisfies the other specifications

of such declaration; or

(B) who uses the covered countermeasure, or to

whom the covered countermeasure is

App. 51

administered, in a good faith belief that the

individual is in the category described by

subparagraph (A).

(3) Covered injury

The term “covered injury” means serious physical

injury or death.

(4) Declaration

The term “declaration” means a declaration under

section 247d-6d(b) of this title.

(5) Eligible individual

The term “eligible individual” means an individual

who is determined, in accordance with subsection

(b), to be a covered individual who sustains a

covered injury.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.