PRIA, Government Policy, Made Personal

Summary

A biomaterials supplier who is sued can ask the court to dismiss the case whenever dismissal motions are allowed. The supplier can argue one of four things: it is not the implant’s manufacturer (see 1604(b)); it is not a liable seller (see 1604(c)); it did not supply raw materials or parts that failed to meet contract or specs (see 1604(d)); or the plaintiff failed to name the implant’s manufacturer as a party. A plaintiff must name the implant’s manufacturer unless the manufacturer can only be served in a place where the supplier cannot be served, or the claim against the manufacturer is legally barred. If the supplier files a dismissal motion, discovery is paused except for jurisdiction issues. If the motion says the supplier did not furnish bad parts, the court may allow limited discovery about that issue or jurisdiction. Both sides may file affidavits. The judge decides the motion only on the pleadings and those affidavits and must dismiss unless the plaintiff’s affidavit shows the defendant is not a biomaterials supplier, or the judge finds the supplier may be liable, or the manufacturer wasn’t named. The court can treat the motion like summary judgment and enter judgment without a trial if no genuine factual issue exists on the 1604(d) elements. Dismissals are with prejudice, though a defendant may be rejoined under 1606. A manufacturer may run or pay for the supplier’s defense if they have a valid agreement.

Title 21, §1605

Food and Drugs, Source: USLM XML via OLRC

(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 1604(b) of this title.

(2)The defendant is not liable as a seller, as provided in section 1604(c) of this title.

(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.

(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 chapter, 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.

(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

(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 360(j) of this title.

(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 1604(b)(2)(B) of this title; or

(ii)the defendant is a seller of the implant who is liable under section 1604(c) of this title.

(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 1604(b) of this title;

(ii)the defendant may be liable as a seller, as provided in section 1604(c) of this title; 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 1604(d) of this title; 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 judgment

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.

(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 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.

(B)Issues of material fact

With respect to a finding made under subparagraph (A), the court shall consider a genuine issue of material fact to exist only if the evidence submitted by the claimant would be sufficient to allow a reasonable jury to reach a verdict for the claimant if the jury found the evidence to be credible.

(2)Discovery made prior to a ruling on a motion for summary judgment

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.

(3)Discovery with respect to a biomaterials supplier

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.

(e)Dismissal with prejudice

An order granting a motion to dismiss or for summary judgment pursuant to this section shall be entered with prejudice, except insofar as the moving defendant may be rejoined to the action as provided in section 1606 of this title.

(f)Manufacturer conduct of litigation

The manufacturer of an implant that is the subject of an action covered under this chapter shall be permitted to conduct litigation on any motion for summary judgment or dismissal filed by a biomaterials supplier who is a defendant under this section on behalf of such supplier if the manufacturer and any other defendant in such action enter into a valid and applicable contractual agreement under which the manufacturer agrees to bear the cost of such litigation or to conduct such litigation.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1605 Procedures for Dismissal of Civil Actions Against Biomaterials Suppliers

Summary

Title 21, §1605

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Citations & Metadata