
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC1604]

 
                        TITLE 21--FOOD AND DRUGS
 
                CHAPTER 21--BIOMATERIALS ACCESS ASSURANCE
 
Sec. 1604. Liability of biomaterials suppliers


(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.

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

                  Section Referred to in Other Sections

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