Petition for Writ of Certiorari — San Marino Gardens Wellness Center, LP, dba Pasadena Park Healthcare and Wellness Center, Petitioner v. Susan Olmes, Individually and as Heir and Successor in Interest to the Estate of Michael Olmes

APPENDIX

i

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 Order Granting Motion to Remand in

the United States District Court

Central District of California

(March 4, 2022) . . . . . . . . . . . . . . . App. 5

Appendix C Statutory Provisions Involved . . . App. 7

42 U.S.C. § 247d-6d . . . . . . . . . App. 7

42 U.S.C. § 247d-6e . . . . . . . . App. 36

App. 1

APPENDIX A

NOT FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

No. 22-55289

D.C. No. 2:21-cv-09375-DSF-SK

[Filed June 21, 2023]

_________________________________________

SUSAN OLMES, Individually and as heir

)

and Successor in Interest to the Estate of

)

Michael Olmes,

)

)

Plaintiff-Appellee,

)

)

v.

)

)

SAN MARINO GARDENS WELLNESS

)

CENTER, LP, DBA Pasadena Park

)

Healthcare and Wellness Center,

)

)

Defendant-Appellant.

)

_________________________________________ )

MEMORANDUM*

*

This disposition is not appropriate for publication and is not

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

App. 2

Appeal from the United States District Court

for the Central District of California

Dale S. Fischer, District Judge, Presiding

Submitted June 20, 2023 **

Before: WALLACE, O’SCANNLAIN, and SILVERMAN,

Circuit Judges.

San Marino Gardens Wellness Center, LP (“San

Marino”) appeals from the district court’s order

remanding this case to state court for lack of federal

subject matter jurisdiction. San Marino 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.

I

The district court did not have federal subject

matter jurisdiction under the federal officer removal

statute, 28 U.S.C. § 1442(a)(1), because San Marino’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 San

Marino has demonstrated that, like the defendants in

Saldana, it was subject to federal laws and regulations

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,

**

The panel unanimously concludes this case is suitable for

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

App. 3

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.

II

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

federal defense is not a sufficient basis to find

embedded federal question jurisdiction.” Id.

App. 4

IV

In short, all of San Marino’s challenges are

controlled by Saldana. San Marino 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

CV 21-9375 DSF (SKx)

[Filed March 4, 2022]

__________________________

SUSAN OLMES,

)

Plaintiff,

)

)

v.

)

)

SAN MARINO GARDENS )

WELLNESS CENTER, LP, )

Defendant.

)

__________________________ )

Order GRANTING Motion to Remand (Dkt. 14)

Defendant removed this case on several grounds

relating to federal government COVID-19 directives

and the PREP Act. In a case presenting identical legal

issues, the Ninth Circuit recently found that the

federal courts lacked subject matter jurisdiction over

the plaintiff’s claims. Saldana v. Glenhaven Healthcare

LLC, -- F.4th --, 2022 WL 518989 (Feb. 22, 2022).

Therefore, the motion to remand is GRANTED and the

case is REMANDED to the Superior Court of

California, County of Los Angeles.

IT IS SO ORDERED.

App. 6

Date: March 4, 2022

/s/ Dale S. Fischer

Dale S. Fischer

United States District Judge

App. 7

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. 8

(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. 9

(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

(C) in addition, in the case of a covered person

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. 10

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. 11

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. 12

description of events, including factors specified

in paragraph (6);

(C) the population or populations of individuals

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. 13

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.

(C) Additional period for certain strategic

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. 14

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. 15

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. 16

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.

(c) Definition of willful misconduct

(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. 17

(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.

(C) Temporal scope of regulations

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. 18

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. 19

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. 20

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. 21

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.

(C) Rules of construction

(i) In general

Nothing in

construed—

this

paragraph

shall

be

(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. 22

(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. 23

(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

(C) facts supporting the allegation that the

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. 24

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.

(C) Materials required

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. 25

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. 26

(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. 27

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).

(C) Collateral source benefit defined

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. 28

(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. 29

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. 30

(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);

(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 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. 31

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

of

such

(iv) a qualified person who prescribed,

a dm ini st ered, or di spensed 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. 32

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;

or

subcontractor

of

a

(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

(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

App. 33

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. 34

(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. 35

(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

(C) necessitates medical or surgical intervention

to preclude permanent impairment of a body

function or permanent damage to a body

structure.

App. 36

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. 37

(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. 38

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.

(C) Judicial review

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

shall have subject matter jurisdiction to review,

App. 39

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

(C) other terms used in those sections shall have

the meanings given to such terms by this

section.

(c) Voluntary program

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. 40

(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. 41

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. 42

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.