Jeffrey Connell v. Lima Corporate
988 F.3d 1089
| 9th Cir. | 2021Background
- DJO (Encore Medical) contracted with Italian manufacturer Lima for a modular revision Hip Stem; DJO obtained FDA 510(k) clearance and handled sterilization, labeling, packaging, and Instructions for Use in DJO’s name.
- The Hip Stem required additional components (femoral head, acetabular shell, liner) to function and could not be implanted as supplied by Lima.
- Jeffrey Connell received a hip implant including the Hip Stem; the femoral stem later fractured and the explanted parts were discarded; Connells sued DJO and Lima for product liability and related claims.
- Connells settled with DJO; DJO was dismissed with prejudice; Lima moved for summary judgment claiming immunity under the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. § 1601 et seq.
- The district court granted summary judgment for Lima; on appeal the Ninth Circuit held (1) Lima is a "biomaterials supplier" under the BAAA because the Hip Stem is a component part supplied "for use in the manufacture of an implant," and (2) § 1606(a) does not allow impleader because there were no other defendants remaining when Lima was dismissed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Lima is a "biomaterials supplier" under the BAAA | Hip Stem was an "implant" (so Lima is not just a supplier) because it was intended to be placed into the body | Hip Stem is a manufactured piece that cannot function alone and thus is a component part supplied for use in manufacture of the final implant | Held: Lima is a "biomaterials supplier"; the Hip Stem is a component part, not an "implant" under the BAAA definition |
| Meaning of "implant" vs. "component part" under the BAAA | Any item that is inserted into the body (or intended to be) qualifies as an implant | "Implant" requires a device intended by the manufacturer to be implanted by itself; parts intended to be combined are component parts | Held: "Implant" requires manufacturer intent to implant the item alone; a part requiring combination is a component part |
| Whether Lima supplied the Hip Stem "for use in the manufacture" of an implant | The connection/processing by DJO makes Lima a manufacturer or otherwise outside immunity | Lima supplied a piece that was used (assembled, sterilized, packaged) to produce the final implant; that satisfies ordinary meaning of "for use in the manufacture" | Held: Lima supplied the Hip Stem for use in the manufacture of the final hip implant and meets §1602(1) elements |
| Whether claimant could implead Lima under 21 U.S.C. §1606(a) after DJO settled and was dismissed | Connells argued impleader should be allowed despite DJO dismissal/settlement | §1606 requires that there be other "remaining defendants" after the biomaterials supplier is dismissed; no remaining defendants existed here | Held: §1606 does not permit impleader because there were no other defendants remaining when Lima was dismissed; impleader denied |
Key Cases Cited
- BedRoc Ltd., LLC v. United States, 541 U.S. 176 (statutory interpretation starts and ends with text if unambiguous)
- Lamie v. U.S. Tr., 540 U.S. 526 (courts must enforce plain statutory text)
- Perrin v. United States, 444 U.S. 37 (words given ordinary meaning at time of enactment)
- Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S. Ct. 1938 (preemption analyzed by plain wording of clause)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (use statutory purpose and context in preemption analysis)
- Robinson v. Shell Oil Co., 519 U.S. 337 (interpret text in its specific and broader statutory context)
- Young v. United Parcel Serv., Inc., 135 S. Ct. 1338 (avoid interpretations that render statutory language superfluous)
- Barnhart v. Sigmon Coal Co., 534 U.S. 438 (read omissions in statutory definitions as intentional)
- Riley v. Kennedy, 553 U.S. 406 (definition of "final judgment" ends litigation on the merits)