HR 956 EH1S
that is material and relevant to the harm suffered
by the claimant; or
(3) the biomaterials supplier had actual knowl-
edge of prospective fraudulent or malicious activities
in the use of its supplies where such activities are
relevant to the harm suffered by the claimant.
SEC. 302. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS
AGAINST BIOMATERIALS SUPPLIERS.
(a) MOTION TO DISMISS.—
(1) GENERAL RULE.—Any biomaterials supplier
who is a defendant in any product liability action in-
volving a medical device which allegedly caused the
harm for which the action is brought and who did
not take part in the design, manufacture, or sale of
such medical device may, at any time during which
a motion to dismiss may be filed under an applicable
law, move to dismiss the action on the grounds
that—
(A) the claimant has failed to establish
that the supplier furnished raw materials or
component parts in violation of applicable con-
tractual requirements or specifications agreed
to by the biomaterials supplier; or
(B) the claimant has failed to comply with
the requirements of subsection (b).
HR 956 EH1S
(2) EXCEPTION.—The biomaterials supplier
may not move to dismiss the action if—
(A) the biomaterials supplier intentionally
and wrongfully withheld or misrepresented in-
formation that is material and relevant to the
harm suffered by the claimant; or
(B) the biomaterials supplier had actual
knowledge of prospective fraudulent or mali-
cious activities in the use of its supplies where
such activities are relevant to the harm suffered
by the claimant.
(b) MANUFACTURER OF MEDICAL DEVICE SHALL BE
NAMED A PARTY.—The claimant shall be required to
name the manufacturer of the medical device to which the
biomaterials supplier furnished raw materials or compo-
nent parts as a party to the product liability action, un-
less—
(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) an action against the manufacturer is
barred by applicable law.
HR 956 EH1S
(c) PROCEEDINGS ON MOTION TO DISMISS.—The fol-
lowing rules shall apply to any proceeding on a motion
to dismiss filed under this section:
(1) AFFIDAVITS RELATING TO STATUS OF DE-
FENDANT.—
(A) DEFENDANT AFFIDAVIT.—The defend-
ant in the action may support a motion to dis-
miss by filing an affidavit demonstrating that
defendant is a biomaterials supplier and that it
is neither the manufacturer nor the product
seller of the medical device which caused the
harm alleged by the claimant.
(B) RESPONSE TO MOTION TO DISMISS.—
In response to a motion to dismiss described in
this section, the claimant may submit an affida-
vit demonstrating why it asserts that—
(i) the defendant who filed the motion
to dismiss is not a biomaterials supplier
with respect to the medical device which
caused the harm alleged by the claimant;
(ii) on what basis it asserts that the
supplier furnished raw materials or compo-
nent parts in violation of applicable con-
tractual requirements or specifications
agreed to by the biomaterials supplier;
HR 956 EH1S
(iii) the biomaterials supplier inten-
tionally and wrongfully withheld or mis-
represented information that is material
and relevant to the harm suffered by the
claimant; or
(iv) the biomaterials supplier had ac-
tual knowledge of prospective fraudulent or
malicious activities in the use of its sup-
plies where such activities are relevant to
the harm suffered by the claimant.
(2) EFFECT OF MOTION TO DISMISS ON DIS-
COVERY.—If a defendant files a motion to dismiss,
no discovery shall be permitted in connection with
the action that is the subject of the motion, unless
the affidavits submitted in accordance with this
section raise material issues of fact concerning
whether—
(A) the supplier furnished raw materials or
component parts in violation of applicable con-
tractual requirements or specifications agreed
to by the biomaterials supplier;
(B) the biomaterials supplier intentionally
and wrongfully withheld or misrepresented in-
formation that is material and relevant to the
harm suffered by the claimant; or
HR 956 EH1S
(C) the biomaterials supplier had actual
knowledge of prospective fraudulent or mali-
cious activities in the use of its supplies where
such activities are relevant to the harm suffered
by the claimant.
Any such discovery shall be limited solely to such
material facts.
(3) RESPONSE TO MOTION TO DISMISS.—The
court shall rule on the motion to dismiss solely on
the basis of the affidavits filed under this section
and on the basis of any evidence developed in the
course of discovery under paragraph (2) and subse-
quently submitted to the court in accordance with
applicable rules of evidence.
(d) ATTORNEY FEES.—The court shall require the
claimant to compensate the biomaterials supplier for at-
torney fees and costs, if—
(1) 
the 
claimant 
named 
or 
joined 
the
biomaterials supplier; and
(2) the court found the claim against the
biomaterials supplier to be without merit and frivo-
lous.
SEC. 303. DEFINITIONS.
For purposes of this title:
HR 956 EH1S
(1) The term ‘‘biomaterials supplier’’ means an
entity that directly or indirectly supplies, or licenses
another person to supply, a component part or raw
material for use in the manufacture of a medical de-
vice—
(A) 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 of internal human tissue through a
surgically produced opening for a period of
less than 30 days; and
(B) suture materials used in implant pro-
cedures.
(2) Notwithstanding paragraph (1), the term
‘‘biomaterials supplier’’ excludes any person, with re-
spect to a medical device which is the subject of a
product liability action—
(A) who 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 medical device, and
HR 956 EH1S
has or should have registered with the Sec-
retary of Health and Human Services pursuant
to section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) and the regula-
tions issued under such section, and has or
should have included the medical device on a
list of devices filed with the Secretary of Health
and Human Services pursuant to section 510(j)
of such Act (21 U.S.C. 360(j)) and the regula-
tions issued under such section; or
(B) who, in the course of a business con-
ducted for that purpose, has sold, distributed,
leased, packaged, labeled, or otherwise placed
the implant in the stream of commerce after it
was manufactured.
(3) The term ‘‘harm’’ means any physical in-
jury, illness, disease, or death or damage to property
caused by a product. The term does not include
commercial loss or loss or damage to a product
itself.
(4) The term ‘‘product liability action’’ means
a civil action brought on any theory for harm caused
by a product or product use.
HR 956 EH1S
(5) preempt State choice-of-law rules with re-
spect to claims brought by a foreign nation or a citi-
zen of a foreign nation; or
(6) affect the right of any court to transfer
venue or to apply the law of a foreign nation or to
dismiss a claim of a foreign nation or of a citizen
of a foreign nation on the ground of inconvenient
forum.
SEC. 403. FEDERAL CAUSE OF ACTION PRECLUDED.
The district courts of the United States shall not
have jurisdiction pursuant to this Act based on section
1331 or 1337 of title 28, United States Code.
SEC. 404. EFFECTIVE DATE.
Titles I, II, and III shall apply with respect to actions
which are commenced after the date of the enactment of
this Act.
Passed the House of Representatives March 10,
1995.
Attest:
Clerk.
104TH CONGRESS
1ST SESSION
H. R. 956
AN ACT
To establish legal standards and procedures for
product liability litigation, and for other purposes.