Page:United States Statutes at Large Volume 112 Part 2.djvu/642

 112 STAT. 1526 PUBLIC LAW 105-230—AUG. 13, 1998 (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 510, 513, 515, or 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360, 360c, 360e, or 360j), 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. Courts. SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST 21 USC 1605. BIOMATERIALS SUPPLIERS. (a) MOTION TO DISMISS. —^A defendant may, at any time during which a motion to dismiss may be filed under applicable law, move to dismiss an action against it on the grounds that the defendant is a biomaterials supplier and one or more of the following: (1) The defendant is not liable as a manufacturer, as provided in section 5(b). (2) The defendant is not liable as a seller, as provided in section 5(c). (3) The defendant is not 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). (4) The claimant did not name the manufacturer as a party to the action, as provided in subsection (b). (b) MANUFACTURER OF IMPLANT SHALL BE NAMED A PARTY. — In any civil action covered by this Act, the claimant shall be required to name the manufacturer of the implant as a party to the action, unless— (1) the manufacturer is subject to service of process solely in a jurisdiction in which the biomaterials supplier is not domiciled or subject to a service of process; or (2) a claim against the manufacturer is barred by applicable law or rule of practice. Applicability. (c) PROCEEDING ON MOTION TO DISMISS. — The following rules shall apply to any proceeding on a motion to dismiss filed by a defendant under this section: (1) EFFECT OF MOTION TO DISMISS ON DISCOVERY. — (A) IN GENERAL. —Except as provided in subparagraph (B), if a defendant files a motion to dismiss under subsection (a), no discovery shall be permitted in connection with the action that is the subject of the motion, other than discovery necessary to determine a motion to dismiss for lack of jurisdiction, until such time as the court rules on the motion to dismiss. (B) DISCOVERY.— I f a defendant files a motion to dismiss under subsection (a)(3) on the grounds that it did not furnish raw materials or component parts for the

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