§1604 — Title 21 Food and Drugs | U.S. Code

Summary

Stops biomaterials suppliers from being automatically responsible if an implant hurts someone. A supplier is only liable if one of three things is true: the supplier is treated as the implant’s manufacturer, the supplier acted as a seller of the implant after the maker’s first sale, or the supplier provided raw materials or parts that didn’t meet the contract or required specifications and that failure caused the harm. To win a claim about bad parts, the injured person must show it is more likely than not that the parts were wrong and that the mistake actually led to the injury. A supplier counts as the manufacturer only if it registered with the FDA and listed the device, or if the FDA issues a declaration saying the supplier should have registered or listed but did not, or if the supplier is owned by the same people as a manufacturer and a court finds, based on sworn statements, that the related manufacturer cannot pay a likely judgment. The FDA can act on its own or after a petition, must give notice and an informal hearing, and must decide a petition within 120 days. While a petition is pending, any time limits for suing are paused, and courts must put related court cases on hold until the FDA decides.

Title 21, §1604

Food and Drugs — Source: USLM XML via OLRC

(a)Except as provided in section 1606 of this title, a biomaterials supplier shall not be liable for harm to a claimant caused by an implant unless such supplier is liable—

(1)as a manufacturer of the implant, as provided in subsection (b);

(2)as a seller of the implant, as provided in subsection (c); or

(3)for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in subsection (d).

(b)(1)A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the biomaterials supplier is the manufacturer of the implant.

(2)The biomaterials supplier may be considered the manufacturer of the implant that allegedly caused harm to a claimant only if the biomaterials supplier—

(A)(i)registered or was required to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii)included or was required to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section;

(B)is the subject of a declaration issued by the Secretary pursuant to paragraph (3) that states that the supplier, with respect to the implant that allegedly caused harm to the claimant, was required to—

(i)register with the Secretary under section 360 of this title, and the regulations issued under such section, but failed to do so; or

(ii)include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section, but failed to do so; or

(C)is related by common ownership or control to a person meeting all the requirements described in subparagraph (A) or (B), if the court deciding a motion to dismiss in accordance with section 1605(c)(3)(B)(i) of this title finds, on the basis of affidavits submitted in accordance with section 1605 of this title, that it is necessary to impose liability on the biomaterials supplier as a manufacturer because the related manufacturer meeting the requirements of subparagraph (A) or (B) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the claimant prevail.

(3)(A)The Secretary may issue a declaration described in paragraph (2)(B) on the motion of the Secretary or on petition by any person, after providing—

(i)notice to the affected persons; and

(ii)an opportunity for an informal hearing.

(B)Immediately upon receipt of a petition filed pursuant to this paragraph, the Secretary shall docket the petition. Not later than 120 days after the petition is filed, the Secretary shall issue a final decision on the petition.

(C)Any applicable statute of limitations shall toll during the period from the time a claimant files a petition with the Secretary under this paragraph until such time as either (i) the Secretary issues a final decision on the petition, or (ii) the petition is withdrawn.

(D)If a claimant has filed a petition for a declaration with respect to a defendant, and the Secretary has not issued a final decision on the petition, the court shall stay all proceedings with respect to that defendant until such time as the Secretary has issued a final decision on the petition.

(c)A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable as a seller for harm to a claimant caused by an implant only if—

(1)the biomaterials supplier—

(A)held title to the implant and then acted as a seller of the implant after its initial sale by the manufacturer; or

(B)acted under contract as a seller to arrange for the transfer of the implant directly to the claimant after the initial sale by the manufacturer of the implant; or

(2)the biomaterials supplier is related by common ownership or control to a person meeting all the requirements described in paragraph (1), if a court deciding a motion to dismiss in accordance with section 1605(c)(3)(B)(ii) of this title finds, on the basis of affidavits submitted in accordance with section 1605 of this title, that it is necessary to impose liability on the biomaterials supplier as a seller because the related seller meeting the requirements of paragraph (1) lacks sufficient financial resources to satisfy any judgment that the court feels it is likely to enter should the claimant prevail.

(d)A biomaterials supplier may, to the extent required and permitted by any other applicable law, be liable for harm to a claimant caused by an implant if the claimant in an action shows, by a preponderance of the evidence, that—

(1)the biomaterials supplier supplied raw materials or component parts for use in the implant that either—

(A)did not constitute the product described in the contract between the biomaterials supplier and the person who contracted for the supplying of the product; or

(B)failed to meet any specifications that were—

(i)accepted, pursuant to applicable law, by the biomaterials supplier;

(ii)published by the biomaterials supplier;

(iii)provided by the biomaterials supplier to the person who contracted for such product;

(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 360, 360c, 360e, or 360j of this title, 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.

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.

§1604 Liability of Biomaterials Suppliers

Summary

Title 21, §1604

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Citations & Metadata