[House Report 105-549]
[From the U.S. Government Publishing Office]



105th Congress                                            Rept. 105-549
                        HOUSE OF REPRESENTATIVES

 2d Session                                                      Part 2
_______________________________________________________________________


 
               BIOMATERIALS ACCESS ASSURANCE ACT OF 1998

_______________________________________________________________________


                 July 14, 1998.--Ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 872]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Commerce, to whom was referred the bill 
(H.R. 872) to establish rules governing product liability 
actions against raw materials and bulk component suppliers to 
medical device manufacturers, and for other purposes, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose..........................................................     9
Summary..........................................................    10
Background and Need for Legislation..............................    11
Hearings.........................................................    11
Committee Consideration..........................................    12
Rollcall Votes...................................................    12
Committee Oversight Findings.....................................    12
Committee on Government Reform and Oversight.....................    12
New Budget Authority, Entitlement Authority, and Tax Expenditures    12
Committee Cost Estimate..........................................    13
Congressional Budget Office Estimate.............................    13
Federal Mandates Statement.......................................    14
Advisory Committee Statement.....................................    14
Constitutional Authority Statement...............................    14
Applicability to Legislative Branch..............................    14
Section-by-Section Analysis of the Legislation...................    14
Changes in Existing Law Made by the Bill, as Reported............    16
Additional Views.................................................    17

                               amendment

    The amendment is as follows:
    Strike out all after the enacting clause and insert in lieu 
thereof the following:

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;
            (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 life-saving 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 life-saving 
        medical devices, although such protections do not protect 
        negligent suppliers.

SEC. 3. DEFINITIONS.

     As used in this Act:
            (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 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.
                    (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, 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 where--
                                    (I) the sale or use of the implant 
                                is incidental to such services; and
                                    (II) the essence of the 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, where such purchaser intends to use the device 
        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 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--
            (1) is a manufacturer of the implant, as provided in 
        subsection (b);
            (2) is a seller of the implant, as provided in subsection 
        (c); or
            (3) furnished 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) has 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--
                            (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. The Secretary shall 
                complete review of any such petition within 120 days of 
                receipt of 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;
                            (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.--The claimant 
in an action brought for harm caused by an implant 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 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 judgment.--
        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 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.--Except as provided in section 7, an 
order granting a motion to dismiss or for summary judgment pursuant to 
this section shall be entered with prejudice.
    (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
                    (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 subject to 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.

                                purpose

    H.R. 872 protects biomaterials suppliers from litigation 
over injuries caused by medical devices, except in unusual 
cases where the biomaterials supplier actually manufactured or 
sold the device (as opposed to just supplying the materials), 
or where it failed to supply the product according to contract 
specifications. Under current law, biomaterials suppliers are 
rarely found liable for harm caused by defective medical 
devices. However, the legal costs to defend against such claims 
can run into the millions of dollars. Thus, the purpose of this 
legislation is to keep biomaterials suppliers out of lawsuits 
where possible, and to minimize the time and resource costs 
required to obtain a dismissal when litigation occurs.
    H.R. 872 is not intended in any way to impair the recovery 
of an injured party against the manufacturer or seller of a 
defective medical device. While suppliers have no legal duty to 
monitor, test, or provide consumer warnings regarding the 
products in which their supplies are used, manufacturers of 
consumer products (and in some instances the seller) do have a 
duty to take reasonable steps to make sure that their products 
are safe. Manufacturers of medical devices, in particular, are 
subject to a rigorous review process by the Food and Drug 
Administration (FDA) to ensure an adequate level of safety and 
efficacy of their products, including the materials used during 
production of a medical implant. This bill reflects and affirms 
the general common law position that the burden of 
responsibility for the safety of medical implants, including 
all of their raw materials and component parts, must fall upon 
the manufacturer (and in certain cases the seller) of the 
implant, and not the suppliers who provided their supplies 
according to contract specifications.
    In the extraordinary case where the fraudulent conduct of a 
biomaterials supplier was the cause of a claimant's injury from 
a medical implant, a provision was added to the bill which 
would allow a court to bring the supplier back into the case 
for allocation of damages. Specifically, the bill allows a 
court to implead a dismissed biomaterials supplier back into a 
case where the negligence or intentionally tortious conduct of 
the dismissed supplier was an actual and proximate cause of the 
harm to the claimant and either the manufacturer has argued 
that its liability for damages should accordingly be reduced or 
the court finds that the claimant is unlikely to recover its 
full damages from the remaining defendants. To date, however, 
the Committee is not aware of any court that has ever found a 
biomaterials supplier liable for intentional or negligent 
conduct.

                                summary

    In general, H.R. 872 applies to any civil action brought by 
a claimant physically harmed by a medical implant. It excludes 
a biomaterials supplier from liability for harm to a claimant 
from an implant unless such supplier is a manufacturer of the 
implant, a seller of the implant, or failed to meet applicable 
contract requirements or specifications in providing its 
biomaterials.
    A defendant can move to dismiss itself from an action on 
the grounds that it is a biomaterials supplier and it is not 
liable (1) as a manufacturer, (2) as a supplier, (3) for 
furnishing raw materials or component parts that failed to meet 
applicable contractual requirements or specifications, or (4) 
because the claimant did not name the manufacturer as a party 
to the action. No discovery is allowed in the case after such a 
motion to dismiss is filed, except for discovery related to 
jurisdictional issues and limited discovery relevant to a claim 
that the biomaterials supplier failed to furnish materials or 
parts for the implant that met applicable contractual 
requirements or specifications.
    The court is required to rule on the motion to dismiss 
solely on the basis of the pleadings and any relevant 
affidavits submitted, granting such motion unless the claimant 
demonstrates that the defendant is not a biomaterials supplier, 
or the court determines that the defendant may be liable as a 
manufacturer, seller, or for failure to meet applicable 
contractual requirements or specifications, or because the 
claimant failed to name the manufacturer as a party to the 
action. The court may treat a motion to dismiss (regarding 
meeting contractual requirements and specifications) as a 
motion for summary judgment under certain circumstances, 
granting such motion if there is no genuine issue of material 
fact existing sufficient to allow a reasonable jury to reach a 
verdict for the claimant.
    A manufacturer or claimant may, within 90 days after entry 
of a judgment, motion to implead back into the case a 
biomaterials supplier who had earlier been dismissed pursuant 
tothis Act. This can only happen if (1) the manufacturer 
asserts and the court determines that (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 accordingly be reduced; or 
(2) the claimant requests and the court finds that (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 recover its full damages from the remaining 
defendants. A biomaterials supplier impleaded after dismissal may 
supplement the records of the proceeding, and may only be found liable 
to the extent required and permitted under applicable law.

                  Background and Need for Legislation

    For over two decades, the Committee on Commerce has 
grappled with the issue of product liability reform. 
Historically, injuries caused by defective products gave rise 
to a tort action in State courts. As transportation and 
communications systems developed, more products crossed State 
boundaries, increasing the volume of interstate commerce 
exponentially and creating more interstate product liability 
claims. Products manufactured in one State are now sold in 
another, and may cause injury in yet a third jurisdiction. 
Because each State has different rules governing recovery in 
tort, forum shopping is encouraged, common law has developed 
unevenly, and manufacturers are found liable for conduct in one 
State that would fail to give rise to a cause of action in 
another.
    In order to safeguard the availability of a wide variety of 
lifesaving and life-enhancing medical devices, the Committee 
has determined that immediate action is needed to address 
biomaterials liability. Biomaterials are component parts or raw 
materials supplied for the manufacture of medical implants. 
Almost 8 million Americans have had their lives saved or 
improved by implantable medical devices containing 
biomaterials. According to a study by Dr. Marvin S. Aronoff 
presented to the Committee last year, 75 percent of the 
suppliers of biomaterials required for implantable medical 
devices have banned sales to U.S. device manufacturers--a 42 
percent decline in just a three year time period. One hundred 
percent of these suppliers have cited liability exposure as a 
key factor in discontinuing sales of their products to medical 
device manufacturers. Fourteen major biomaterials suppliers 
have now limited or stopped selling critical raw materials for 
use in implantable medical devices altogether, with many 
biomaterial supplies no longer available or only available from 
small companies with uncertain long term financial stability.
    Manufacturers of many life saving medical devices are 
currently relying on stockpiled biomaterials which may run out 
before the end of 1998. Smaller manufacturers, in particular, 
will be increasingly unable to obtain necessary biomaterials as 
suppliers continue to be forced to withdraw from the market 
over liability concerns. For example, a primary producer of 
polytetrafluoroethylene (PTFE) chose to withdraw last year from 
supplying the permanent medical implant market, recognizing 
that its annual out-of-pocket costs for liability exposure were 
about $8 million for a single type of medical device, while the 
annual revenues from that market were less than $500,000. Even 
though in almost every case the biomaterials suppliershave been 
ultimately able to establish their lack of culpability, the legal fees 
and employee resources involved in obtaining a judgment or dismissal 
usually outweighed any profits to be gained from the relatively small 
biomaterials markets. Without legal reform, decreasing consumer access 
to critical biomaterials products may be inevitable.

                                Hearings

    The Subcommittee on Telecommunications, Trade, and Consumer 
Protection held a hearing on whether our legal system is 
jeopardizing consumers' access to life-saving products, 
focusing in particular on the need for biomaterials access 
assurance, on April 8, 1997. The Subcommittee received 
testimony from the following witnesses: The Honorable George W. 
Gekas, U.S. House of Representatives, Seventeenth District, 
Commonwealth of Pennsylvania; Belinda and Titus Simonini, 
private citizens; Rita Bergmann, private citizen; Karen M. 
Hicks, PhD., private citizen; Neil Kahanovitz, M.D., President, 
Center for Patient Advocacy; Ronald W. Dollens, President and 
CEO, Guidant Corporation; Andrew F. Popper, Professor of Law, 
Washington College of Law, American University; Mark A. 
Behrens, Senior Associate, Crowell and Moring LLP; and Marvin 
S. Aronoff, PhD., President, Aronoff Associates.

                        Committee Consideration

    On June 17, 1998, the Subcommittee on Telecommunications, 
Trade, and Consumer Protection met in open markup session and 
approved H.R. 872, the Biomaterials Access Assurance Act of 
1998, for Full Committee consideration, amended, by a voice 
vote, a quorum being present. On June 24, 1998, the Full 
Committee met in open markup session to consider H.R. 872 and 
ordered the bill reported to the House, as amended, by a voice 
vote, a quorum being present.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House of 
Representatives requires the Committee to list the recorded 
votes on the motion to report legislation and amendments 
thereto. There were no recorded votes taken in connection with 
ordering H.R. 872 reported. A motion by Mr. Bliley to order 
H.R. 872 reported to the House, as amended, was agreed to by a 
voice vote, a quorum being present.

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee held a legislative 
hearing and made findings that are reflected in this report.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee finds that 
H.R 872, the Biomaterials Access Assurance Act of 1998, would 
result in no new or increased budget authority, entitlement 
authority, or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the Rules of 
the House of Representatives, the following is the cost 
estimate provided by the Congressional Budget Office pursuant 
to section 402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, June 30, 1998.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 872, the 
Biomaterials Access Assurance Act of 1998.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Susanne S. 
Mehlmen (for federal costs) and Pepper Santalucia (for the 
state and local impact).
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

H.R. 872--Biomaterials Access Assurance Act of 1998

    CBO estimates that enacting this bill would have no 
significant impact on the federal budget. Because the bill 
would not affect direct spending or receipts, pay-as-you-go 
procedures would not apply.
    Under H.R. 872, suppliers of biomaterials (raw materials 
used to make medical implants and devices) would not be liable 
in federal or state courts for harm to a claimant caused by a 
medical implant or device unless the generic raw material used 
in the medical implant or device violated contract 
specifications or the biomaterials supplier could be classified 
as either a manufacturer or seller of the medical implant or 
device. In addition, H.R. 872 would establish expedited court 
procedures for determining whether a supplier of biomaterials 
is protected from liability.
    While some product liability cases are tried in federal 
court, the majority of such cases are handled in state courts. 
Based on information from the Administrative Office of the 
United States Courts, CBO estimates that enacting this bill 
would have no significant impact on the number of cases that 
would be referred to federal courts. Thus, we estimate that 
enacting H.R. 872 would have no significant impact on the 
federal budget.
    The bill contains intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act (UMRA) because it would 
preempt state tort laws and would establish new court 
procedures for determining whether a supplier of biomaterials 
is protected from liability. State could initially incur some 
costs in adjusting to the new procedures. Based on information 
from the National Center for State Courts about the number of 
product liability cases heard in state courts, CBO estimates 
that those costs would be well below the threshold established 
in the law ($50 million in 1996, adjusted annually for 
inflation). In the longer run, states could realize net savings 
if this bill were to discourage potential plaintiffs from 
filing suits against suppliers of biomaterials. This bill would 
impose no new private-sector mandates as defined in UMRA.
    On April 13, 1998, CBO transmitted a cost estimate for H.R. 
872, as ordered reported by the House Committee on the 
Judiciary on April 1, 1998. The two versions of the bill are 
similar and CBO estimates that both versions would have no 
significant impact on the federal budget.
    The CBO staff contacts for this estimate are Susanne S. 
Mehlman (for federal costs) and Pepper Santalucia (for the 
state and local impact). This estimate was approved by Robert 
A. Sunshine, Deputy Assistant Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 2(l)(4) of rule XI of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    Section 1 states the short title of the bill as the 
``Biomaterials Access Assurance Act of 1998.''

Section 2. Findings

    Section 2 contains the findings setting forth the need and 
basis for the legislation.

Section 3. Definitions

    Section 3 establishes definitions for certain terms used in 
the Act.

Section 4. General requirements; applicability; preemption

    Section 4 sets forth the general requirements, 
applicability, and preemption standards for the bill. The Act 
applies to any civil action brought by a claimant harmed 
directly or indirectly by an implant. The Act does not apply to 
commercial loss or contract cases. The Act only preempts State 
law to the extent that the Act establishes a rule of law 
applicable to the recovery of damages for the applicable harm, 
and it does not preempt other available defenses or create a 
new cause of action or Federal jurisdiction.

Section 5. Liability of biomaterials suppliers

    Section 5 excludes a biomaterials supplier from liability 
for harm to a claimant from an implant unless such supplier is 
a manufacturer of the implant, a seller of the implant, or 
failed to meet applicable contract requirements or 
specifications.
    The biomaterials supplier may be liable to the extent 
permitted under otherwise applicable law as a seller of the 
implant if it (A) held title to the implant and then acted as a 
seller after the initial sale by the implant's manufacturer, or 
(B) acted under contract as a seller to arrange for the 
transfer of the implant to the claimant after the implant's 
initial sale by the manufacturer. The biomaterials supplier may 
also be liable as a seller if it is related by common ownership 
or control to someone who is liable as a seller of the implant.
    The biomaterials supplier may also be liable for harm 
caused by an implant if the claimant shows by a preponderance 
of the evidence that (1) the biomaterials supplier supplied raw 
materials or component parts for the implant that either did 
not constitute the product contracted for, or failed to meet 
any applicable specifications accepted, published, or provided 
by the biomaterials supplier, contained in a master file 
submitted by the biomaterials supplier to the Secretary of 
Health and Human Services (the Secretary), or included in the 
submissions to the Secretary for premarket approval and 
accepted 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.

Section 6. Procedures for dismissal of civil actions against 
        biomaterials suppliers

    Subsection (a) allows a defendant in an applicable case to 
motion to dismiss an action against it on the grounds that it 
is a biomaterials supplier and it is not liable (1) as a 
manufacturer, (2) as a supplier, (3) for furnishing raw 
materials or component parts that failed to meet applicable 
contractual requirements or specifications, or (4) because the 
claimant did not name the manufacturer as a party to the 
action.
    Subsection (b) requires a claimant to name the manufacturer 
of the implant as a party to the action unless 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 if such a claim would be barred under 
law.
    Subsection (c) sets forth the procedures for a motion to 
dismiss. In general, no discovery is allowed in connection with 
an action after a motion to dismiss is filed under this Act, 
except for discovery related to jurisdictional issues and 
limited discovery relevant to a claim that thebiomaterials 
supplier failed to furnish materials or parts for the implant that met 
applicable contractual requirements or specifications. The court shall 
rule on a motion to dismiss solely on the basis of the pleadings and 
any relevant affidavits submitted, granting such motion unless the 
claimant demonstrates that the defendant is not a biomaterials 
supplier, or the court determines that the defendant may be liable as a 
manufacturer, seller, or for failure to meet applicable contractual 
requirements or specifications, or because the claimant failed to name 
the manufacturer as a party to the action. The court may treat a motion 
to dismiss (regarding meeting contractual requirements and 
specifications) as a motion for summary judgment under certain 
circumstances.
    Subsection (d) provides the standards for adjudicating a 
motion to dismiss that is treated as a motion for summary 
judgment, requiring the court to grant such motion if, after 
limited discovery based on the applicable rules for nonparties, 
there is no genuine issue of material fact existing sufficient 
to allow a reasonable jury to reach a verdict for the claimant.
    Subsection (e) requires a court granting a motion to 
dismiss or for summary judgment to enter such motion with 
prejudice against the claimant.
    Subsection (f) allows a manufacturer to represent a 
biomaterials supplier in court on a motion for dismissal or 
summary judgment.

Section 7. Subsequent impleader of dismissed biomaterials supplier

    Section 7 allows a manufacturer or claimant within 90 days 
after entry of a judgment to motion to implead back into the 
case a biomaterials supplier who had earlier been dismissed 
pursuant to this Act. This can only happen if (1) the 
manufacturer asserts and the court determines that (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 accordingly be reduced; or (2) the claimant requests and 
the court finds that (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 recover its full damages from the 
remaining defendants. A biomaterials supplier impleaded after 
dismissal may supplement the records of the proceeding, and may 
only be found liable to the extent required and permitted under 
applicable law.

Section 8. Effective date

    Section 8 makes the Act effective for any actions commenced 
after enactment.

         Changes in Existing Law Made by the Bill, as Reported

    H.R. 872 does not amend any existing Federal statute.

                      ADDITIONAL VIEWS ON H.R. 872

    Our support and the support of many of our colleagues on 
the Judiciary Committee who previously voted for H.R. 872 is 
contingent on one very specific understanding: that this 
legislation not be expanded beyond the form reported by the 
Commerce Committee.
    Even in the legislation as reported, we have some concerns 
relating to the scope of its protections. While we understand 
the arguments made in support of this legislation as it relates 
to the supply of raw materials, this bill also protects the 
manufacturers of ``component parts'' of inplantable devices. 
Raw materials, such as silicone or polyethelene, are vastly 
different subject matter from components, which can be as 
technically diverse as batteries, tubes, wiring and pacemaker 
leads. Yet there is little, if any, substantiation in the 
legislative record by broadening H.R. 872's protections to the 
manufacturers of such components.
    While we supported the bill moving forward, we believe 
liability protection for manufacturers of component parts 
should be carefully reviewed before this bill achieves final 
passage. If the provision remains in the bill, it should be 
construed as narrowly as possible to avoid unintended 
consequences of limiting liability of the makers of the 
manufactured pieces of such devices.
    But our primary concerns arise from any potential expansion 
in the scope and effect of H.R. 872. We would be strongly 
opposed to changes in which FDA-regulated products are included 
within the class of biomaterials that receive special 
protections in this bill. Moreover, we would also oppose any 
effort to make H.R. 872 a vehicle for broader product liability 
protections in the House or in the Senate.
    On June 23, 1998, we received a letter from Jim Benson, 
executive vice president of the Health Industry Manufacturers 
Association (HIMA), assuring us that it is the intention of 
that organization to oppose any effects to change the bill as 
reported or encumber it with other legislative items.
    This possibility is not mere speculation. On July 9, 1998, 
the New York Times reported that Senate Majority Leader Lott 
had handwritten an amendment into the Senate version of H.R. 
872 on behalf of a major medical device manufacturer, Baxter 
International. Baxter recently lost a $18 million lawsuit to 
the family of Andrina Hansen, who suffered severe brain damage 
because of a faulty Baxter intravenous, or IV, connector.
    In 1991, Mrs. Hansen underwent surgery for a bleeding 
ulcer. After successful surgery, the disconnection of a 
postoperative IV forced air into her brain, causing a stroke. 
Mrs. Hansen spent four years in a nursing home as a 
quadriplegic before she died. When her family took legal 
action, all defendants settled except Baxter Healthcare, a 
subsidiary of Baxter International and the manufacturer of the 
faulty IV connector.
    According to the court record, Baxter's internal memoranda 
documented the company's awareness that its IV connector design 
allowed IV tubing to slip. This defect was also the subject to 
almost 70 lawsuits over 20 years. Baxter also manufactured a 
newer, improved connector which prevented fatal incidents like 
Mrs. Hansen's. But Baxter never warned patients or health 
providers of these problems.
    The proposed Senate amendment would insulate Baxter and 
similar undeserving manufacturers of components parts of 
``containers and their related products to be used to collect 
fluids or tissue from the body or to infuse or to otherwise 
introduce fluids or tissue into the body'' from liability for 
defective and dangerous products. This would be true even is it 
was the component, such as Baxter's defective IV connector, and 
not the entire device which was the cause of injuries or 
deaths.
    In a July 10 letter to Senate Majority Leader Lott, Alan 
Magazine, president, and Ronald Dollens, chairman-elect of HIMA 
wrote of their organization's very serious concerns about 
expanding [H.R. 872] to medical devices not considered during 
the four-year long debate on this legislation.''
    We take them at their word in this commitment, and we 
accept the assurance of our colleagues on the Commerce 
Committee that passage of this bill without amendment is their 
intention. But if that is not the case--if it is amended 
adversely on the House floor or becomes a vehicle for 
unwarranted Senate changes--then we will not support it and in 
fact will do all we can to see that it does not become law.

                                   Sherrod Brown.
                                   Edward J. Markey.
                                   Henry A. Waxman.
                                   Diana DeGette.

                                
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