Tatro v. C R Bard Incorporated
2:19-cv-02180
| D. Ariz. | Oct 17, 2019Background
- MDL consolidated >8,000 product-liability cases alleging C.R. Bard IVC filters (Recovery, G2, G2X, Eclipse, Meridian, Denali) are defective and lacked adequate warnings. 3 bellwether trials occurred; one more settled. Many cases settled; thousands now ready for remand/transfer.
- Transferee court (D. Ariz.) completed all common fact and general expert discovery and decided numerous Daubert, summary-judgment, and in limine motions affecting common issues; remaining issues are case-specific.
- The court suggested remand of one Panel-transferred case (Schedule A) to the Southern District of Indiana under 28 U.S.C. § 1407 and ordered transfer of numerous direct-filed MDL cases (Schedule B) to districts identified in their short-form complaints under 28 U.S.C. § 1404(a).
- The opinion summarizes MDL management (lead counsel, PSC/PEC, CMOs), discovery phases, bellwether selection, and trial rulings to assist receiving courts; common discovery will not need repetition, but case-specific fact and expert discovery and trial prep remain for receiving courts.
- Key evidentiary rulings summarized: federal preemption denied on MDA §360k grounds for 510(k)-cleared devices; admission of certain FDA 510(k)/warning-letter evidence and limits on Recovery cephalad-migration death evidence varied by filter generation and case-specific relevance; Lehmann consultant report protected as work product.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether transferee court should suggest remand under §1407 | Cases no longer benefit from centralized proceedings; ready for transfer/trial | Keep cases centralized for efficiency | Suggested remand of Schedule A case to transferor court; direct-filed cases transferred under §1404(a) to districts in short-form complaints |
| Whether direct-filed MDL cases should be transferred under §1404(a) | Short-form complaints identified proper transferee venues; case-specific issues belong to local courts | Opposed only as to specific procedural rights; preserved challenges to venue/Jurisdiction | Ordered transfer of Schedule B cases to the districts listed; defendants may renew venue/personal-jurisdiction defenses after transfer |
| Whether state-law claims are preempted by MDA §360k for 510(k)-cleared devices | Plaintiffs: 510(k) substantial-equivalence review does not create device-specific federal requirements that preempt state law | Bard: federal 510(k) process and related records impose federal requirements that preempt state claims | Court denied summary judgment on express and implied preemption; relied on Medtronic v. Lohr principle that 510(k) generally does not preempt state common-law claims |
| Admissibility of FDA materials and recovery-death evidence (Daubert / MIL issues) | Plaintiffs: FDA materials and certain Recovery deaths are relevant to design, state of mind, and punitive damages for some filters | Bard: FDA evidence and distant Recovery death evidence are prejudicial, hearsay, or irrelevant for later-generation filters | Court admitted some FDA 510(k)/warning-letter evidence as relevant; limited or redacted Recovery cephalad-death evidence depending on filter generation and case-specific relevance; Lehmann report excluded as work product |
Key Cases Cited
- Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) (transferee court may only suggest remand; Panel controls remand decisions)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) substantial-equivalence review generally does not create federal requirements that preempt state-law claims)
- In re Multi-Piece Rim Prods. Liab. Litig., 464 F. Supp. 969 (J.P.M.L. 1979) (transferee courts may suggest remand when cases no longer benefit from centralized pretrial proceedings)