Page:United States Statutes at Large Volume 112 Part 2.djvu/643

 PUBLIC LAW 105-230—AUG. 13, 1998 112 STAT. 1527 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 JUDG- MENT.— 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

�