H. R. 872

One Hundred Fifth Congress

of the

United States of America

AT THE SECOND SESSION

Begun and held at the City of Washington on Tuesday,

the twenty-seventh day of January, one thousand nine hundred and ninety-eight

An Act

To establish rules governing product liability actions against raw materials and

bulk component suppliers to medical device manufacturers, and for other purposes.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Biomaterials Access Assurance

Act of 1998’’.

SEC. 2. FINDINGS.

The Congress finds that—

(1) each year millions of citizens of the United States

depend on the availability of lifesaving or life-enhancing medical devices, many of which are permanently implantable within

the human body;

(2) a continued supply of raw materials and component

parts is necessary for the invention, development, improvement,

and maintenance of the supply of the devices;

(3) most of the medical devices are made with raw materials

and component parts that—

(A) move in interstate commerce;

(B) are not designed or manufactured specifically for

use in medical devices; and

(C) come in contact with internal human tissue;

(4) the raw materials and component parts also are used

in a variety of nonmedical products;

(5) because small quantities of the raw materials and

component parts are used for medical devices, sales of raw

materials and component parts for medical devices constitute

an extremely small portion of the overall market for the raw

materials and component parts;

(6) under the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 301 et seq.) manufacturers of medical devices are

required to demonstrate that the medical devices are safe and

effective, including demonstrating that the products are properly designed and have adequate warnings or instructions;

(7) notwithstanding the fact that raw materials and component parts suppliers do not design, produce, or test a final

medical device, the suppliers have been the subject of actions

alleging inadequate—

(A) design and testing of medical devices manufactured

with materials or parts supplied by the suppliers; or

(B) warnings related to the use of such medical devices;
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(8) even though suppliers of raw materials and component

parts have very rarely been held liable in such actions, such

suppliers have ceased supplying certain raw materials and

component parts for use in medical devices for a number of

reasons, including concerns about the costs of such litigation;

(9) unless alternate sources of supply can be found, the

unavailability of raw materials and component parts for medical

devices will lead to unavailability of lifesaving and life-enhancing medical devices;

(10) because other suppliers of the raw materials and

component parts in foreign nations are refusing to sell raw

materials or component parts for use in manufacturing certain

medical devices in the United States, the prospects for development of new sources of supply for the full range of threatened

raw materials and component parts for medical devices are

remote;

(11) it is unlikely that the small market for such raw

materials and component parts in the United States could

support the large investment needed to develop new suppliers

of such raw materials and component parts;

(12) attempts to develop such new suppliers would raise

the cost of medical devices;

(13) courts that have considered the duties of the suppliers

of the raw materials and component parts have generally found

that the suppliers do not have a duty—

(A) to evaluate the safety and efficacy of the use of

a raw material or component part in a medical device;

or

(B) to warn consumers concerning the safety and

effectiveness of a medical device;

(14) because medical devices and the raw materials and

component parts used in their manufacture move in interstate

commerce, a shortage of such raw materials and component

parts affects interstate commerce;

(15) in order to safeguard the availability of a wide variety

of lifesaving and life-enhancing medical devices, immediate

action is needed—

(A) to clarify the permissible bases of liability for

suppliers of raw materials and component parts for medical

devices; and

(B) to provide expeditious procedures to dispose of

unwarranted suits against the suppliers in such manner

as to minimize litigation costs;

(16) the several States and their courts are the primary

architects and regulators of our tort system; Congress, however,

must, in certain circumstances involving the national interest,

address tort issues, and a threatened shortage of raw materials

and component parts for lifesaving medical devices is one such

circumstance; and

(17) the protections set forth in this Act are needed to

assure the continued supply of materials for lifesaving medical

devices, although such protections do not protect negligent

suppliers.

SEC. 3. DEFINITIONS.

As used in this Act:

(1) BIOMATERIALS SUPPLIER.—
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(A) IN GENERAL.—The term ‘‘biomaterials supplier’’

means an entity that directly or indirectly supplies a

component part or raw material for use in the manufacture

of an implant.

(B) PERSONS INCLUDED.—Such term includes any

person who—

(i) has submitted master files to the Secretary

for purposes of premarket approval of a medical device;

or

(ii) licenses a biomaterials supplier to produce

component parts or raw materials.

(2) CLAIMANT.—

(A) IN GENERAL.—The term ‘‘claimant’’ means any

person who brings a civil action, or on whose behalf a

civil action is brought, arising from harm allegedly caused

directly or indirectly by an implant, including a person

other than the individual into whose body, or in contact

with whose blood or tissue, the implant is placed, who

claims to have suffered harm as a result of the implant.

(B) ACTION BROUGHT ON BEHALF OF AN ESTATE.—With

respect to an action brought on behalf of or through the

estate of a deceased individual into whose body, or in

contact with whose blood or tissue the implant was placed,

such term includes the decedent that is the subject of

the action.

(C) ACTION BROUGHT ON BEHALF OF A MINOR OR

INCOMPETENT.—With respect to an action brought on behalf

of or through a minor or incompetent, such term includes

the parent or guardian of the minor or incompetent.

(D) EXCLUSIONS.—Such term does not include—

(i) a provider of professional health care services

in any case in which—

(I) the sale or use of an implant is incidental

to such services; and

(II) the essence of the professional health care

services provided is the furnishing of judgment,

skill, or services;

(ii) a person acting in the capacity of a manufacturer, seller, or biomaterials supplier; or

(iii) a person alleging harm caused by either the

silicone gel or the silicone envelope utilized in a breast

implant containing silicone gel, except that—

(I) neither the exclusion provided by this

clause nor any other provision of this Act may

be construed as a finding that silicone gel (or any

other form of silicone) may or may not cause harm;

and

(II) the existence of the exclusion under this

clause may not—

(aa) be disclosed to a jury in any civil

action or other proceeding; and

(bb) except as necessary to establish the

applicability of this Act, otherwise be presented in any civil action or other proceeding.

(3) COMPONENT PART.—

(A) IN GENERAL.—The term ‘‘component part’’ means

a manufactured piece of an implant.
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(B) CERTAIN COMPONENTS.—Such term includes a

manufactured piece of an implant that—

(i) has significant non-implant applications; and

(ii) alone, has no implant value or purpose, but

when combined with other component parts and materials, constitutes an implant.

(4) HARM.—

(A) IN GENERAL.—The term ‘‘harm’’ means—

(i) any injury to or damage suffered by an

individual;

(ii) any illness, disease, or death of that individual

resulting from that injury or damage; and

(iii) any loss to that individual or any other

individual resulting from that injury or damage.

(B) EXCLUSION.—The term does not include any

commercial loss or loss of or damage to an implant.

(5) IMPLANT.—The term ‘‘implant’’ means—

(A) a medical device that is intended by the manufacturer of the device—

(i) to be placed into a surgically or naturally formed

or existing cavity of the body for a period of at least

30 days; or

(ii) to remain in contact with bodily fluids or

internal human tissue through a surgically produced

opening for a period of less than 30 days; and

(B) suture materials used in implant procedures.

(6) MANUFACTURER.—The term ‘‘manufacturer’’ means any

person who, with respect to an implant—

(A) is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section

510(a)(1) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360(a)(1))) of the implant; and

(B) is required—

(i) to register with the Secretary pursuant to

section 510 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360) and the regulations issued under

such section; and

(ii) to include the implant on a list of devices

filed with the Secretary pursuant to section 510( j)

of such Act (21 U.S.C. 360( j)) and the regulations

issued under such section.

(7) MEDICAL DEVICE.—The term ‘‘medical device’’ means

a device, as defined in section 201(h) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 321(h)), and includes any

device component of any combination product as that term

is used in section 503(g) of such Act (21 U.S.C. 353(g)).

(8) RAW MATERIAL.—The term ‘‘raw material’’ means a

substance or product that—

(A) has a generic use; and

(B) may be used in an application other than an

implant.

(9) SECRETARY.—The term ‘‘Secretary’’ means the Secretary

of Health and Human Services.

(10) SELLER.—

(A) IN GENERAL.—The term ‘‘seller’’ means a person

who, in the course of a business conducted for that purpose,
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sells, distributes, leases, packages, labels, or otherwise

places an implant in the stream of commerce.

(B) EXCLUSIONS.—The term does not include—

(i) a seller or lessor of real property;

(ii) a provider of professional health care services

in any case in which—

(I) the sale or use of the implant is incidental

to such services; and

(II) the essence of the professional health care

services provided is the furnishing of judgment,

skill, or services; or

(iii) any person who acts in only a financial capacity with respect to the sale of an implant.

SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.

(a) GENERAL REQUIREMENTS.—

(1) IN GENERAL.—In any civil action covered by this Act,

a biomaterials supplier may—

(A) raise any exclusion from liability set forth in section

5; and

(B) make a motion for dismissal or for summary judgment as set forth in section 6.

(2) PROCEDURES.—Notwithstanding any other provision of

law, a Federal or State court in which an action covered by

this Act is pending shall, in connection with a motion under

section 6 or 7, use the procedures set forth in this Act.

(b) APPLICABILITY.—

(1) IN GENERAL.—Except as provided in paragraph (2), this

Act applies to any civil action brought by a claimant, whether

in a Federal or State court, on the basis of any legal theory,

for harm allegedly caused, directly or indirectly, by an implant.

(2) EXCLUSION.—A civil action brought by a purchaser of

a medical device, purchased for use in providing professional

health care services, for loss or damage to an implant or for

commercial loss to the purchaser—

(A) shall not be considered an action that is subject

to this Act; and

(B) shall be governed by applicable commercial or

contract law.

(c) SCOPE OF PREEMPTION.—

(1) IN GENERAL.—This Act supersedes any State law regarding recovery for harm caused by an implant and any rule

of procedure applicable to a civil action to recover damages

for such harm only to the extent that this Act establishes

a rule of law applicable to the recovery of such damages.

(2) APPLICABILITY OF OTHER LAWS.—Any issue that arises

under this Act and that is not governed by a rule of law

applicable to the recovery of damages described in paragraph

(1) shall be governed by applicable Federal or State law.

(d) STATUTORY CONSTRUCTION.—Nothing in this Act may be

construed—

(1) to affect any defense available to a defendant under

any other provisions of Federal or State law in an action

alleging harm caused by an implant; or

(2) to create a cause of action or Federal court jurisdiction

pursuant to section 1331 or 1337 of title 28, United States
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Code, that otherwise would not exist under applicable Federal

or State law.

SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.

(a) IN GENERAL.—Except as provided in section 7, a biomaterials supplier shall not be liable for harm to a claimant caused

by an implant unless such supplier is liable—

(1) as a manufacturer of the implant, as provided in

subsection (b);

(2) as a seller of the implant, as provided in subsection

(c); or

(3) for furnishing raw materials or component parts for

the implant that failed to meet applicable contractual requirements or specifications, as provided in subsection (d).

(b) LIABILITY AS MANUFACTURER.—

(1) IN GENERAL.—A biomaterials supplier may, to the extent

required and permitted by any other applicable law, be liable

for harm to a claimant caused by an implant if the biomaterials

supplier is the manufacturer of the implant.

(2) GROUNDS FOR LIABILITY.—The biomaterials supplier

may be considered the manufacturer of the implant that

allegedly caused harm to a claimant only if the biomaterials

supplier—

(A)(i) registered or was required to register with the

Secretary pursuant to section 510 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360) and the regulations

issued under such section; and

(ii) included or was required to include the implant

on a list of devices filed with the Secretary pursuant to

section 510( j) of such Act (21 U.S.C. 360( j)) and the regulations issued under such section;

(B) is the subject of a declaration issued by the

Secretary pursuant to paragraph (3) that states that the

supplier, with respect to the implant that allegedly caused

harm to the claimant, was required to—

(i) register with the Secretary under section 510

of such Act (21 U.S.C. 360), and the regulations issued

under such section, but failed to do so; or

(ii) include the implant on a list of devices filed

with the Secretary pursuant to section 510( j) of such

Act (21 U.S.C. 360( j)) and the regulations issued under

such section, but failed to do so; or

(C) is related by common ownership or control to a

person meeting all the requirements described in subparagraph (A) or (B), if the court deciding a motion to dismiss

in accordance with section 6(c)(3)(B)(i) finds, on the basis

of affidavits submitted in accordance with section 6, that

it is necessary to impose liability on the biomaterials supplier as a manufacturer because the related manufacturer

meeting the requirements of subparagraph (A) or (B) lacks

sufficient financial resources to satisfy any judgment that

the court feels it is likely to enter should the claimant

prevail.

(3) ADMINISTRATIVE PROCEDURES.—

(A) IN GENERAL.—The Secretary may issue a declaration described in paragraph (2)(B) on the motion of the

Secretary or on petition by any person, after providing—
H. R. 872—7

(i) notice to the affected persons; and

(ii) an opportunity for an informal hearing.

(B) DOCKETING AND FINAL DECISION.—Immediately

upon receipt of a petition filed pursuant to this paragraph,

the Secretary shall docket the petition. Not later than

120 days after the petition is filed, the Secretary shall

issue a final decision on the petition.

(C) APPLICABILITY OF STATUTE OF LIMITATIONS.—Any

applicable statute of limitations shall toll during the period

from the time a claimant files a petition with the Secretary

under this paragraph until such time as either (i) the

Secretary issues a final decision on the petition, or (ii)

the petition is withdrawn.

(D) STAY PENDING PETITION FOR DECLARATION.—If a

claimant has filed a petition for a declaration with respect

to a defendant, and the Secretary has not issued a final

decision on the petition, the court shall stay all proceedings

with respect to that defendant until such time as the

Secretary has issued a final decision on the petition.

(c) LIABILITY AS SELLER.—A biomaterials supplier may, to the

extent required and permitted by any other applicable law, be

liable as a seller for harm to a claimant caused by an implant

only if—

(1) the biomaterials supplier—

(A) held title to the implant and then acted as a

seller of the implant after its initial sale by the manufacturer; or

(B) acted under contract as a seller to arrange for

the transfer of the implant directly to the claimant after

the initial sale by the manufacturer of the implant; or

(2) the biomaterials supplier is related by common ownership or control to a person meeting all the requirements

described in paragraph (1), if a court deciding a motion to

dismiss in accordance with section 6(c)(3)(B)(ii) finds, on the

basis of affidavits submitted in accordance with section 6, that

it is necessary to impose liability on the biomaterials supplier

as a seller because the related seller meeting the requirements

of paragraph (1) lacks sufficient financial resources to satisfy

any judgment that the court feels it is likely to enter should

the claimant prevail.

(d) LIABILITY FOR FAILURE TO MEET APPLICABLE CONTRACTUAL

REQUIREMENTS OR SPECIFICATIONS.—A biomaterials supplier may,

to the extent required and permitted by any other applicable law,

be liable for harm to a claimant caused by an implant if the

claimant in an action shows, by a preponderance of the evidence,

that—

(1) the biomaterials supplier supplied raw materials or

component parts for use in the implant that either—

(A) did not constitute the product described in the

contract between the biomaterials supplier and the person

who contracted for the supplying of the product; or

(B) failed to meet any specifications that were—

(i) accepted, pursuant to applicable law, by the

biomaterials supplier;

(ii) published by the biomaterials supplier;

(iii) provided by the biomaterials supplier to the

person who contracted for such product;
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(iv) contained in a master file that was submitted

by the biomaterials supplier to the Secretary and that

is currently maintained by the biomaterials supplier

for purposes of premarket approval of medical devices;

or

(v) included in the submissions for purposes of

premarket approval or review by the Secretary under

section 510, 513, 515, or 520 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360, 360c, 360e,

or 360j), and received clearance from the Secretary

if such specifications were accepted, pursuant to

applicable law, by the biomaterials supplier; and

(2) such failure to meet applicable contractual requirements

or specifications was an actual and proximate cause of the

harm to the claimant.

SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST

BIOMATERIALS SUPPLIERS.

(a) MOTION TO DISMISS.—A defendant may, at any time during

which a motion to dismiss may be filed under applicable law,

move to dismiss an action against it on the grounds that

the defendant is a biomaterials supplier and one or more of the

following:

(1) The defendant is not liable as a manufacturer, as

provided in section 5(b).

(2) The defendant is not liable as a seller, as provided

in section 5(c).

(3) The defendant is not liable for furnishing raw materials

or component parts for the implant that failed to meet

applicable contractual requirements or specifications, as provided in section 5(d).

(4) The claimant did not name the manufacturer as a

party to the action, as provided in subsection (b).

(b) MANUFACTURER OF IMPLANT SHALL BE NAMED A PARTY.—

In any civil action covered by this Act, the claimant shall be

required to name the manufacturer of the implant as a party

to the action, unless—

(1) the manufacturer is subject to service of process solely

in a jurisdiction in which the biomaterials supplier is not domiciled or subject to a service of process; or

(2) a claim against the manufacturer is barred by applicable

law or rule of practice.

(c) PROCEEDING ON MOTION TO DISMISS.—The following rules

shall apply to any proceeding on a motion to dismiss filed by

a defendant under this section:

(1) EFFECT OF MOTION TO DISMISS ON DISCOVERY.—

(A) IN GENERAL.—Except as provided in subparagraph

(B), if a defendant files a motion to dismiss under subsection (a), no discovery shall be permitted in connection

with the action that is the subject of the motion, other

than discovery necessary to determine a motion to dismiss

for lack of jurisdiction, until such time as the court rules

on the motion to dismiss.

(B) DISCOVERY.—If a defendant files a motion to dismiss under subsection (a)(3) on the grounds that it did

not furnish raw materials or component parts for the
H. R. 872—9

implant that failed to meet applicable contractual requirements or specifications, the court may permit discovery

limited to issues that are directly relevant to—

(i) the pending motion to dismiss; or

(ii) the jurisdiction of the court.

(2) AFFIDAVITS.—

(A) DEFENDANT.—A defendant may submit affidavits

supporting the grounds for dismissal contained in its

motion to dismiss under subsection (a). If the motion is

made under subsection (a)(1), the defendant may submit

an affidavit demonstrating that the defendant has not

included the implant on a list, if any, filed with the Secretary pursuant to section 510( j) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360( j)).

(B) CLAIMANT.—In response to a motion to dismiss,

the claimant may submit affidavits demonstrating that—

(i) the Secretary has, with respect to the defendant

and the implant that allegedly caused harm to the

claimant, issued a declaration pursuant to section

5(b)(2)(B); or

(ii) the defendant is a seller of the implant who

is liable under section 5(c).

(3) BASIS OF RULING ON MOTION TO DISMISS.—The court

shall rule on a motion to dismiss filed under subsection (a)

solely on the basis of the pleadings and affidavits of the parties

made pursuant to this subsection. The court shall grant a

motion to dismiss filed under subsection (a)—

(A) unless the claimant submits a valid affidavit that

demonstrates that the defendant is not a biomaterials supplier;

(B) unless the court determines, to the extent raised

in the pleadings and affidavits, that one or more of the

following apply:

(i) the defendant may be liable as a manufacturer,

as provided in section 5(b);

(ii) the defendant may be liable as a seller, as

provided in section 5(c); or

(iii) the defendant may be liable for furnishing

raw materials or component parts for the implant that

failed to meet applicable contractual requirements or

specifications, as provided in section 5(d); or

(C) if the claimant did not name the manufacturer

as a party to the action, as provided in subsection (b).

(4) TREATMENT OF MOTION AS MOTION FOR SUMMARY JUDG- MENT.—The court may treat a motion to dismiss as a motion

for summary judgment subject to subsection (d) in order to

determine whether the pleadings and affidavits, in connection

with such action, raise genuine issues of material fact

concerning whether the defendant furnished raw materials or

component parts of the implant that failed to meet applicable

contractual requirements or specifications as provided in section

5(d).

(d) SUMMARY JUDGMENT.—

(1) IN GENERAL.—

(A) BASIS FOR ENTRY OF JUDGMENT.—If a motion to

dismiss of a biomaterials supplier is to be treated as a

motion for summary judgment under subsection (c)(4) or
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if a biomaterials supplier moves for summary judgment,

the biomaterials supplier shall be entitled to entry of judgment without trial if the court finds there is no genuine

issue of material fact for each applicable element set forth

in paragraphs (1) and (2) of section 5(d).

(B) ISSUES OF MATERIAL FACT.—With respect to a finding made under subparagraph (A), the court shall consider

a genuine issue of material fact to exist only if the evidence

submitted by the claimant would be sufficient to allow

a reasonable jury to reach a verdict for the claimant if

the jury found the evidence to be credible.

(2) DISCOVERY MADE PRIOR TO A RULING ON A MOTION

FOR SUMMARY JUDGMENT.—If, under applicable rules, the court

permits discovery prior to a ruling on a motion for summary

judgment governed by section 5(d), such discovery shall be

limited solely to establishing whether a genuine issue of material fact exists as to the applicable elements set forth in paragraphs (1) and (2) of section 5(d).

(3) DISCOVERY WITH RESPECT TO A BIOMATERIALS SUPPLIER.—A biomaterials supplier shall be subject to discovery

in connection with a motion seeking dismissal or summary

judgment on the basis of the inapplicability of section 5(d)

or the failure to establish the applicable elements of section

5(d) solely to the extent permitted by the applicable Federal

or State rules for discovery against nonparties.

(e) DISMISSAL WITH PREJUDICE.—An order granting a motion

to dismiss or for summary judgment pursuant to this section shall

be entered with prejudice, except insofar as the moving defendant

may be rejoined to the action as provided in section 7.

(f ) MANUFACTURER CONDUCT OF LITIGATION.—The manufacturer of an implant that is the subject of an action covered under

this Act shall be permitted to conduct litigation on any motion

for summary judgment or dismissal filed by a biomaterials supplier

who is a defendant under this section on behalf of such supplier

if the manufacturer and any other defendant in such action enter

into a valid and applicable contractual agreement under which

the manufacturer agrees to bear the cost of such litigation or

to conduct such litigation.

SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED BIOMATERIALS

SUPPLIER.

(a) IMPLEADING OF DISMISSED DEFENDANT.—A court, upon

motion by a manufacturer or a claimant within 90 days after

entry of a final judgment in an action by the claimant against

a manufacturer, and notwithstanding any otherwise applicable statute of limitations, may implead a biomaterials supplier who has

been dismissed from the action pursuant to this Act if—

(1) the manufacturer has made an assertion, either in

a motion or other pleading filed with the court or in an opening

or closing statement at trial, or as part of a claim for contribution or indemnification, and the court finds based on the court’s

independent review of the evidence contained in the record

of the action, that under applicable law—

(A) the negligence or intentionally tortious conduct

of the dismissed supplier was an actual and proximate

cause of the harm to the claimant; and
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(B) the manufacturer’s liability for damages should

be reduced in whole or in part because of such negligence

or intentionally tortious conduct; or

(2) the claimant has moved to implead the supplier and

the court finds, based on the court’s independent review of

the evidence contained in the record of the action, that under

applicable law—

(A) the negligence or intentionally tortious conduct

of the dismissed supplier was an actual and proximate

cause of the harm to the claimant; and

(B) the claimant is unlikely to be able to recover the

full amount of its damages from the remaining defendants.

(b) STANDARD OF LIABILITY.—Notwithstanding any preliminary

finding under subsection (a), a biomaterials supplier who has been

impleaded into an action covered by this Act, as provided for in

this section—

(1) may, prior to entry of judgment on the claim against

it, supplement the record of the proceeding that was developed

prior to the grant of the motion for impleader under subsection

(a); and

(2) may be found liable to a manufacturer or a claimant

only to the extent required and permitted by any applicable

State or Federal law other than this Act.

(c) DISCOVERY.—Nothing in this section shall give a claimant

or any other party the right to obtain discovery from a biomaterials

supplier at any time prior to grant of a motion for impleader

beyond that allowed under section 6.

SEC. 8. EFFECTIVE DATE.

This Act shall apply to all civil actions covered under this

Act that are commenced on or after the date of enactment of

this Act, including any such action with respect to which the harm

asserted in the action or the conduct that caused the harm occurred

before the date of enactment of this Act.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.