View all text of Chapter 21 [§ 1601 - § 1606]
§ 1604. Liability of biomaterials suppliers
(a) In generalExcept 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);
(2) as a seller of the implant, as provided in subsection (c); or
(3) for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in subsection (d).
(b) Liability as manufacturer
(1) In general
(2) Grounds for liabilityThe 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 generalThe 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
(C) Applicability of statute of limitations
(D) Stay pending petition for declaration
(c) Liability as sellerA 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
(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, § 5, Aug. 13, 1998, 112 Stat. 1524.)