Title 21Food and DrugsRelease 119-73

§1606 Subsequent impleader of dismissed biomaterials supplier

Title 21 › Chapter CHAPTER 21— - BIOMATERIALS ACCESS ASSURANCE › § 1606

Last updated Apr 6, 2026|Official source

Summary

A court can allow a manufacturer or a claimant to add back a biomaterials supplier into a case within 90 days after a final judgment, even if the normal time limits would have passed. The court will only do this after it reviews the existing case record and finds that the supplier’s negligence or intentional wrongdoing actually caused the claimant’s harm. If a manufacturer asks, the court must also find the manufacturer’s share of fault should be lowered. If a claimant asks, the court must find the claimant likely cannot recover all damages from the remaining defendants. A supplier who is added back may submit more evidence before a judgment is entered. The supplier can only be held responsible as far as other state or federal law allows. No one can get extra pre-impleader discovery from the supplier beyond what section 1605 permits.

Full Legal Text

Title 21, §1606

Food and Drugs — Source: USLM XML via OLRC

(a)A court, upon motion by a manufacturer or a claimant within 90 days after entry of a final judgment in an action by the claimant against a manufacturer, and notwithstanding any otherwise applicable statute of limitations, may implead a biomaterials supplier who has been dismissed from the action pursuant to this chapter if—
(1)the manufacturer has made an assertion, either in a motion or other pleading filed with the court or in an opening or closing statement at trial, or as part of a claim for contribution or indemnification, and the court finds based on the court’s independent review of the evidence contained in the record of the action, that under applicable law—
(A)the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the claimant; and
(B)the manufacturer’s liability for damages should be reduced in whole or in part because of such negligence or intentionally tortious conduct; or
(2)the claimant has moved to implead the supplier and the court finds, based on the court’s independent review of the evidence contained in the record of the action, that under applicable law—
(A)the negligence or intentionally tortious conduct of the dismissed supplier was an actual and proximate cause of the harm to the claimant; and
(B)the claimant is unlikely to be able to recover the full amount of its damages from the remaining defendants.
(b)Notwithstanding any preliminary finding under subsection (a), a biomaterials supplier who has been impleaded into an action covered by this chapter, as provided for in this section—
(1)may, prior to entry of judgment on the claim against it, supplement the record of the proceeding that was developed prior to the grant of the motion for impleader under subsection (a); and
(2)may be found liable to a manufacturer or a claimant only to the extent required and permitted by any applicable State or Federal law other than this chapter.
(c)Nothing in this section shall give a claimant or any other party the right to obtain discovery from a biomaterials supplier at any time prior to grant of a motion for impleader beyond that allowed under section 1605 of this title.

Legislative History

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 1606

Title 21Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73