Page:United States Statutes at Large Volume 112 Part 2.djvu/641

 PUBLIC LAW 105-230—AUG. 13, 1998 112 STAT. 1525 (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 Deadline. 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paragraph until such time as either (i) the Secretary issues a final decision on the petition, or (ii) the petition is withdrawn.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 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; 59-194O-98 -21:QL3Part2

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