21 U.S.C. § 1604 — Liability of biomaterials suppliers

(a) In general Except as provided in section 1606 of this title , a biomaterials supplier^* must not be liable for harm^* to a claimant^* caused by an implant^* unless that 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 A biomaterials supplier can, 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 can 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^* under section 360 of this title and the regulations issued under that section; and (ii) included or was required to include the implant on a list of devices filed with the Secretary under section 360(j) of this title and the regulations issued under that section; (B) is the subject of a declaration issued by the Secretary under paragraph (3) that states that the supplier, about 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 that section, but failed to do so; or (ii) include the implant on a list of devices filed with the Secretary under section 360(j) of this title and the regulations issued under that section, but failed to do so; or (C) is related by common ownership or control to a person meeting all the requirements described in lettered paragraph (A) or (B), if the court deciding a motion to dismiss under section 1605(c)(3)(B)(i) of this title finds, on the basis of affidavits submitted under 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 lettered paragraph (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 can 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 under this paragraph, the Secretary must docket the petition. Not later than 120 days after the petition is filed, the Secretary must issue a final decision on the petition. (C) Applicability of statute of limitations Any applicable statute of limitations must toll during the period from the time a claimant files a petition with the Secretary under this paragraph until that 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 about a defendant, and the Secretary has not issued a final decision on the petition, the court must stay all proceedings about that defendant until that time as the Secretary has issued a final decision on the petition. (c) Liability as seller A biomaterials supplier can, 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 under section 1605(c)(3)(B)(ii) of this title finds, on the basis of affidavits submitted under 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 can, 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, under applicable law, by the biomaterials supplier; (ii) published by the biomaterials supplier; (iii) provided by the biomaterials supplier to the person who contracted for that 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 that specifications were accepted, under applicable law, by the biomaterials supplier; and (2) that failure to meet applicable contractual requirements or specifications was an actual and proximate cause of the harm to the claimant.