US (United States) Code. Title 21. Chapter 21: Biomaterials access assurance

Codificación normativa de EEUU (Estados Unidos) Legislación Federal estadounidense # Food and drugs

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-CITE-

21 USC CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

.

-HEAD-

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-MISC1-

Sec.

1601. Findings.

1602. Definitions.

1603. General requirements; applicability; preemption.

(a) General requirements.

(b) Applicability.

(c) Scope of preemption.

(d) Statutory construction.

1604. Liability of biomaterials suppliers.

(a) In general.

(b) Liability as manufacturer.

(c) Liability as seller.

(d) Liability for failure to meet applicable

contractual requirements or specifications.

1605. Procedures for dismissal of civil actions against

biomaterials suppliers.

(a) Motion to dismiss.

(b) Manufacturer of implant shall be named a party.

(c) Proceeding on motion to dismiss.

(d) Summary judgment.

(e) Dismissal with prejudice.

(f) Manufacturer conduct of litigation.

1606. Subsequent impleader of dismissed biomaterials supplier.

(a) Impleading of dismissed defendant.

(b) Standard of liability.

(c) Discovery.

-CITE-

21 USC Sec. 1601 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-

Sec. 1601. Findings

-STATUTE-

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;

(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 chapter are needed to

assure the continued supply of materials for lifesaving medical

devices, although such protections do not protect negligent

suppliers.

-SOURCE-

(Pub. L. 105-230, Sec. 2, Aug. 13, 1998, 112 Stat. 1519.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in par.

(6), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,

which is classified generally to chapter 9 (Sec. 301 et seq.) of

this title. For complete classification of this Act to the Code,

see section 301 of this title and Tables.

-MISC2-

EFFECTIVE DATE

Pub. L. 105-230, Sec. 8, Aug. 13, 1998, 112 Stat. 1529, provided

that: ''This Act (enacting this chapter) shall apply to all civil

actions covered under this Act that are commenced on or after the

date of enactment of this Act (Aug. 13, 1998), 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.''

SHORT TITLE

Pub. L. 105-230, Sec. 1, Aug. 13, 1998, 112 Stat. 1519, provided

that: ''This Act (enacting this chapter) may be cited as the

'Biomaterials Access Assurance Act of 1998'.''

-CITE-

21 USC Sec. 1602 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-

Sec. 1602. Definitions

-STATUTE-

As used in this chapter:

(1) Biomaterials supplier

(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 chapter 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 chapter, 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.

(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 360(a)(1) of

this title) of the implant; and

(B) is required -

(i) to register with the Secretary pursuant to section 360

of this title 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 360(j) of this title and

the regulations issued under such section.

(7) Medical device

The term ''medical device'' means a device, as defined in

section 321(h) of this title, and includes any device component

of any combination product as that term is used in section 353(g)

of this title.

(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, 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.

-SOURCE-

(Pub. L. 105-230, Sec. 3, Aug. 13, 1998, 112 Stat. 1520.)

-CITE-

21 USC Sec. 1603 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-

Sec. 1603. General requirements; applicability; preemption

-STATUTE-

(a) General requirements

(1) In general

In any civil action covered by this chapter, a biomaterials

supplier may -

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

1604 of this title; and

(B) make a motion for dismissal or for summary judgment as

set forth in section 1605 of this title.

(2) Procedures

Notwithstanding any other provision of law, a Federal or State

court in which an action covered by this chapter is pending

shall, in connection with a motion under section 1605 or 1606 of

this title, use the procedures set forth in this chapter.

(b) Applicability

(1) In general

Except as provided in paragraph (2), this chapter 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

chapter; and

(B) shall be governed by applicable commercial or contract

law.

(c) Scope of preemption

(1) In general

This chapter 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 chapter establishes a rule of law applicable to

the recovery of such damages.

(2) Applicability of other laws

Any issue that arises under this chapter 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 chapter 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 that otherwise would

not exist under applicable Federal or State law.

-SOURCE-

(Pub. L. 105-230, Sec. 4, Aug. 13, 1998, 112 Stat. 1523.)

-CITE-

21 USC Sec. 1604 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-

Sec. 1604. Liability of biomaterials suppliers

-STATUTE-

(a) In general

Except as provided in section 1606 of this title, 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) of this section;

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

of this section; 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) of this section.

(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 360 of this title 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

360(j) of this title 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 360 of this

title, 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 360(j) of this title 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 1605(c)(3)(B)(i) of this title finds, on the basis

of affidavits submitted in accordance with section 1605 of this

title, 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 -

(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 1605(c)(3)(B)(ii) of this title finds, on

the basis of affidavits submitted in accordance with section 1605

of this title, 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;

(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 360, 360c,

360e, or 360j of this title, 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.

-SOURCE-

(Pub. L. 105-230, Sec. 5, Aug. 13, 1998, 112 Stat. 1524.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1603, 1605 of this title.

-CITE-

21 USC Sec. 1605 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-

Sec. 1605. Procedures for dismissal of civil actions against

biomaterials suppliers

-STATUTE-

(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 1604(b) of this title.

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

section 1604(c) of this title.

(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 1604(d) of this title.

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

the action, as provided in subsection (b) of this section.

(b) Manufacturer of implant shall be named a party

In any civil action covered by this chapter, 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) of this section, 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) of this section on the grounds that it did not furnish

raw materials or component parts for the 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) of this section. If the motion is made under subsection

(a)(1) of this section, 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

360(j) of this title.

(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 1604(b)(2)(B) of

this title; or

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

under section 1604(c) of this title.

(3) Basis of ruling on motion to dismiss

The court shall rule on a motion to dismiss filed under

subsection (a) of this section 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) of this section -

(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 1604(b) of this title;

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

in section 1604(c) of this title; 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 1604(d) of this title; or

(C) if the claimant did not name the manufacturer as a party

to the action, as provided in subsection (b) of this section.

(4) Treatment of motion as motion for summary judgment

The court may treat a motion to dismiss as a motion for summary

judgment subject to subsection (d) of this section 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

1604(d) of this title.

(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) of this section or 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 1604(d) of this

title.

(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

1604(d) of this title, 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 1604(d) of this title.

(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 1604(d) of this title

or the failure to establish the applicable elements of section

1604(d) of this title 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 1606 of this title.

(f) Manufacturer conduct of litigation

The manufacturer of an implant that is the subject of an action

covered under this chapter 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.

-SOURCE-

(Pub. L. 105-230, Sec. 6, Aug. 13, 1998, 112 Stat. 1526.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1603, 1604, 1606 of this

title.

-CITE-

21 USC Sec. 1606 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 21 - BIOMATERIALS ACCESS ASSURANCE

-HEAD-

Sec. 1606. Subsequent impleader of dismissed biomaterials supplier

-STATUTE-

(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

chapter 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

(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) of

this section, a biomaterials supplier who has been impleaded into

an action covered by this chapter, 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) of

this section; 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 chapter.

(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 1605 of this title.

-SOURCE-

(Pub. L. 105-230, Sec. 7, Aug. 13, 1998, 112 Stat. 1528.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1603, 1604, 1605 of this

title.

-CITE-