Fuller v. C R Bard Incorporated
2:18-cv-01414
D. Ariz.Oct 17, 2019Background
- MDL established in D. Ariz. for thousands of personal‑injury suits alleging C.R. Bard IVC filters (Recovery, G2, G2X, Eclipse, Meridian, Denali) are defectively designed and inadequately warned. MDL opened Aug 2015 and largely wound down by May 31, 2019.
- Common fact and expert discovery for the MDL was completed; multiple bellwether trials were conducted (Booker, Jones, Hyde) with mixed outcomes and several dispositive/Daubert rulings entered.
- Thousands of direct‑filed and transferred cases remain; parties identified hundreds unlikely to settle. The court proposed: (1) remand of one transferred case (Schedule A) to the Southern District of Indiana; (2) §1404(a) transfer of many direct‑filed cases (Schedule B) to districts specified in short‑form complaints; and (3) unconsolidation of two Arizona cases (Schedule C).
- Court summarized MDL procedures, leadership, CMOs, completed common discovery, case‑specific discovery protocols (profile forms, PFS/DFS for bellwethers), expert discovery status, and a list of key orders/exhibits to aid receiving courts.
- Key contested legal topics addressed in the MDL and summarized for transferee/remand courts included federal preemption under the MDA (510(k) clearance), admissibility of FDA materials (510(k)/warning letter), Recovery cephalad‑migration death evidence, Lehmann report privilege/work‑product protection, and numerous Daubert and MIL rulings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Authority to remand MDL cases | Remand appropriate when case no longer benefits from centralized pretrial coordination and is ready for transfer/remand. | MDL transferee court lacks unilateral power to remand; Panel controls remand but typically follows transferee suggestion. | Transferee court suggested remand of Schedule A case to transferor court; Panel retains final remand authority (citing 28 U.S.C. §1407 and Lexecon). |
| Transfer of direct‑filed MDL cases under §1404(a) | Cases should be returned/ transferred to districts identified in short‑form complaints for case‑specific proceedings. | Defendants preserve right to challenge venue and jurisdiction after transfer. | Court ordered §1404(a) transfers of direct‑filed cases per CMO 4; defendants’ venue/ personal‑jurisdiction defenses preserved. |
| Federal preemption of state law claims (MDA/510(k)) | Plaintiffs: state common‑law claims not preempted because 510(k) review focuses on equivalence, not device‑specific federal requirements. | Defendants: MDA §360k preempts state requirements that differ from or add to federal device regs; 510(k) review and submissions created federal requirements that preempt state law. | Court denied defendants’ summary judgment preemption motion, holding Lohr remains controlling and defendants failed to show device‑specific federal requirements or impossibility conflict; defendants appealed. |
| Admissibility of FDA evidence and FDA warning letter | Plaintiffs: limit or exclude FDA clearance/enforcement evidence where prejudicial or only marginally relevant (especially Recovery death evidence for later‑generation filters). | Defendants: FDA clearance/no‑action evidence is relevant to design and punitive damages; warning letter topics rebut claims that FDA took no action. | Court admitted certain FDA 510(k)/warning‑letter evidence as relevant (with redactions/limits); excluded or limited other topics where relevance was marginal or prejudice substantial; ruled topic‑specific on Recovery cephalad‑migration death evidence depending on filter generation and case facts. |
| Lehmann report and consultant privilege/work product | Plaintiffs sought access to Dr. Lehmann’s report and related materials. | Defendants asserted work‑product/attorney‑client protection and need for confidentiality. | Court granted protective order: Lehmann report privileged as anticipatory work product; plaintiffs failed to show substantial need/undue hardship to overcome protection. |
Key Cases Cited
- Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) (Panel, not transferee court, has exclusive statutory authority to remand MDL cases under §1407)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) clearance does not generally create federal device‑specific requirements that preempt state common‑law claims)
- In re Multi‑Piece Rim Prods. Liab. Litig., 464 F. Supp. 969 (J.P.M.L. 1979) (transferee court may suggest remand when cases no longer benefit from centralized pretrial proceedings)
- In re TMJ Implants Prods. Liab. Litig., 872 F. Supp. 1019 (D. Minn. 1995) (illustrative standard for transferee court suggesting remand when case‑specific issues remain)