Bradley v. C R Bard Incorporated
2:19-cv-03126
D. Ariz.Oct 17, 2019Background
- MDL No. 15-02641 centralized >8,000 personal-injury cases alleging defects in C.R. Bard retrievable IVC filters (Recovery, G2, G2X, Eclipse, Meridian, Denali). Common fact and general expert discovery completed; multiple bellwether trials held, some verdicts and appeals pending.
- Court concluded the MDL’s primary purposes (coordinated discovery and resolution of common issues) were satisfied and many cases had settled; a subset of cases remain unlikely to settle and no longer benefit from centralized proceedings.
- Court suggested remand of one Panel‑transferred case (Schedule A) back to the Southern District of Indiana and ordered transfer under 28 U.S.C. §1404(a) of numerous direct‑filed MDL cases to the districts identified in plaintiffs’ short‑form complaints (Schedule B); two Arizona cases were unconsolidated and remain in D. Ariz. (Schedule C).
- Key pretrial rulings already made in the MDL include denial of device preemption under the MDA for 510(k)‑cleared devices, numerous Daubert decisions on general experts, multiple motions in limine (notably about FDA evidence and Recovery cephalad‑migration death evidence), and a protective‑order/work‑product ruling excluding the Lehmann report.
- The transferee court summarized CMOs, discovery protocols, completed common discovery, which materials will be transmitted on remand/transfer, and advised receiving courts that case‑specific fact and expert discovery remains to be scheduled locally.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the Panel should remand MDL cases ready for local adjudication | Cases no longer benefit from centralized processes; remand appropriate for case‑specific resolution | Centralization still useful for remaining management or interlocutory appeals | Transferee judge suggested remand of the Panel‑transferred case and ordered §1404(a) transfers of direct‑filed cases to identified districts; clerk to transmit records |
| Proper vehicle to transfer direct‑filed MDL cases | Short‑form complaints identified proper transfer districts; transfer is appropriate | Defendants preserve venue and jurisdiction challenges after transfer | Court ordered transfers under 28 U.S.C. §1404(a) to districts listed in short‑form complaints |
| Preemption (MDA §360k) of state‑law claims for 510(k)‑cleared devices | Plaintiffs: 510(k) clearance does not create device‑specific federal requirements that preempt state law (Lohr) | Bard: federal review and certain 510(k)/postmarket processes support preemption | Court denied summary judgment on preemption, finding Lohr controls and defendants failed to show device‑specific federal requirements; defendants appealed |
| Admissibility of FDA evidence and FDA warning letter topics | Plaintiffs sought to exclude evidence of 510(k) clearance and lack of FDA enforcement as potentially confusing/prejudicial | Bard argued FDA clearance and lack of enforcement are relevant to design/punitive/due‑diligence issues | Court allowed limited FDA evidence (including some 510(k) context); redacted portions of the July 13, 2015 warning letter admitted only for relevant topics (topic 3) and with balancing under Rules 401/403 |
| Recovery cephalad‑migration death evidence (use of other‑device deaths) | Plaintiffs: prior Recovery deaths show knowledge, causation, design risks and state of mind relevant to some claims | Bard: evidence is prejudicial, not sufficiently similar to later filters (G2/G2X/Eclipse); risk of jury emotion | Court admitted Recovery death evidence in some contexts (e.g., Booker/G2 and cases where Recovery was the device at issue) but excluded or redacted it in trials involving later filters (Eclipse, G2X, etc.) where probative value was substantially outweighed by prejudice; rulings varied by trial |
| Lehmann report and consultant communications | Plaintiffs sought the Lehmann consulting report | Bard claimed work‑product and privilege protection | Court granted protective order; Lehmann report held protected work product and not producible absent substantial need (which plaintiffs failed to show) |
Key Cases Cited
- Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) (Panel, not transferee court, has exclusive authority to remand MDL cases under 28 U.S.C. §1407)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) substantial‑equivalence review generally does not create federal 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 authority on suggesting remand of matured MDL cases)
