§1604. Liability of biomaterials suppliers — Inbound Citations
21 U.S.C. § 1604
Cited by 13 provisions in release 119-102.
Citations to 21 U.S.C. § 1604 as a whole
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(A) raise any exclusion from liability set forth in section 1604 of this title; and
Citations to §1604(b)
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(1) The defendant is not liable as a manufacturer, as provided in section 1604(b) of this title.
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(i) the defendant may be liable as a manufacturer, as provided in section 1604(b) of this title;
Citations to §1604(b)(2)(B)
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(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 1604(b)(2)(B) of this title; or
Citations to §1604(c)
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(2) The defendant is not liable as a seller, as provided in section 1604(c) of this title.
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(ii) the defendant is a seller of the implant who is liable under section 1604(c) of this title.
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(ii) the defendant may be liable as a seller, as provided in section 1604(c) of this title; or
Citations to §1604(d)
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(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 1604(d) of this title.
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(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 1604(d) of this title; or
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(4) 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 1604(d) of this title.
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(A) If a motion to dismiss of a biomaterials supplier is to be treated as a motion for summary judgment under subsection (c)(4) or if a biomaterials supplier moves for summary judgment, the biomaterials supplier shall be entitled to entry of judgment without trial if the court finds there is no genuine issue of material fact for each applicable element set forth in paragraphs (1) and (2) of section 1604(d) of this title.
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(2) If, under applicable rules, the court permits discovery prior to a ruling on a motion for summary judgment governed by section 1604(d) of this title, such discovery shall be limited solely to establishing whether a genuine issue of material fact exists as to the applicable elements set forth in paragraphs (1) and (2) of section 1604(d) of this title.
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(3) A biomaterials supplier shall be subject to discovery in connection with a motion seeking dismissal or summary judgment on the basis of the inapplicability of section 1604(d) of this title or the failure to establish the applicable elements of section 1604(d) of this title solely to the extent permitted by the applicable Federal or State rules for discovery against nonparties.