In re Bard IVC Filters Products Liability Litigation

          ORDER AND SUGGESTION OF REMAND

          David G. Campbell Senior United States District Judge.

         This multidistrict litigation proceeding (“MDL”) involves thousands of personal injury cases brought against Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”). Bard manufactures and markets medical devices, including inferior vena cava (“IVC”) filters. The MDL Plaintiffs have received implants of Bard IVC filters and claim that they are defective and have caused Plaintiffs to suffer serious injury or death.

         The MDL was transferred to this Court in August 2015 when 22 cases had been filed. Doc. 1. To date, more than 4, 000 cases have been filed. The Court has concluded that 10 mature cases listed on Schedule A should be remanded to the transferor courts. Doc. 11659 at 5. The Court therefore provides this Suggestion of Remand to the United States Judicial Panel for Multidistrict Litigation (the “Panel”).

         To assist the transferor courts on remand, if ordered by the Panel, this order describes events that have taken place in the mature cases and the MDL as a whole. A copy of this order, along with the case files and materials, will be available to the transferor courts after remand.

         I. Background.

         The IVC is a large vein that returns blood to the heart from the lower body. An IVC filter is a small device implanted in the IVC to catch blood clots before they reach the heart and lungs. This MDL involves multiple versions of Bard IVC filters - the Recovery, G2, G2X, Eclipse, Meridian, and Denali. These are umbrella-shaped devices that have multiple limbs fanning out from a cone-shaped head. The limbs consist of legs with hooks that attach to the IVC wall and curved arms to catch or break up blood clots. Each of these filters is a variation of its predecessor.^[1]

         The MDL Plaintiffs allege that Bard filters are more dangerous than other IVC filters because they have higher risks of tilting, perforating the IVC, or fracturing and migrating to vital organs. Plaintiffs further allege that Bard failed to warn patients and physicians about these higher risks. Defendants dispute these allegations, contending that Bard filters are safe and effective, that their complication rates are low and comparable to those of other IVC filters, and that the medical community is aware of the risks associated with IVC filters.

         As noted, more than 4, 000 cases have been filed in this MDL since its inception in 2015. By late 2017, the parties completed all common discovery and filed dispositive and Daubert motions. The Court has ruled on Defendants' motion for summary judgment on preemption grounds, decided more than a dozen Daubert motions, and resolved summary judgment motions in four bellwether cases. Two bellwether cases were tried earlier this year. One other bellwether case is set for trial this month, and two more in 2019. No. cases have settled.

         II. Suggestion of Remand.

         A. Remand Standard.

         The power to remand MDL cases rests solely with the Panel. 28 U.S.C. § 1407(a); see Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 28 (1998). The Panel typically relies on the transferee court to suggest when it should order remand. J.P.M.L. Rule 10.1(b)(i); see In re Motor Fuel Temperature Sales Practices Litig., No. 07-MD-1840-KHV, 2012 WL 1963350, at *1 (D. Kan. May 30, 2012). Indeed, the Panel “is reluctant to order a remand absent the suggestion of the transferee judge[.]” J.P.M.L. Rule 10.3(a); see In re Regions Morgan Keegan Sec, Derivative & ERISA Litig, No. 2:09-md-2009-SHM, 2013 WL 5614285, at *2 (W.D. Tenn. Feb. 28, 2013). The transferee court may suggest to the Panel that cases be remanded where they are “ready for trial, or . . . would no longer benefit from inclusion in the coordinated or consolidated pretrial proceedings.” In re Multi-Piece Rim Prods. Liab. Litig., 464 F.Supp. 969, 975 (J.P.M.L. 1979); see In re TMJ Implants Prods. Liab. Litig., 872 F.Supp. 1019, 1038 (D. Minn. 1995).

         B. Ten Mature Cases Should Be Remanded.

         In October 2015, the parties identified 13 cases that were sufficiently advanced to be considered for remand. Doc. 174 at 7-9; see Doc. 363 at 2-3. These cases were designated as “mature cases” in the Court's initial orders. Docs. 519 at 3, 914 at 2. Although the mature cases were more advanced than other cases in the MDL, the parties agreed that they should not be remanded immediately, but instead should remain part of the MDL as possible bellwether cases. Doc. 249 at 6.

         In February 2016, the Court directed the parties to confer and identify the specific discovery, motion practice, and other litigation steps needed for the mature cases. Doc. 519 at 3. The purpose was to remand these cases as soon as reasonably possible, rather than postponing their disposition until the end of the MDL proceeding. Id.

         In April 2016, the parties agreed that 3 of the 13 cases should no longer be deemed mature and instead should be treated like all other cases in this MDL. Doc. 1319 at 2. The remaining 10 cases, listed below, continue to be designated as mature cases:

• Tillman v. C. R. Bard, Inc., No. 3:13-cv-0222 (M.D. Florida)

• Ocasio v. C. R. Bard, Inc., No. 8:13-cv-01962 (M.D. Florida)

• Cason v. C. R. Bard, Inc., No. 1:12-cv-01288 (N.D. Georgia)

• Coker v. C. R. Bard, Inc., No. 1:13-cv-00515 (N.D. Georgia)

• Rivera (McClarty) v. C. R. Bard, Inc., No. 4:14-cv-13627 (E.D. Michigan)

• Ebert v. C. R. Bard, Inc., No. 5:12-cv-01253 (E.D. Pennsylvania)

• Keen v. C. R. Bard, Inc., No. 5:13-cv-05361 (E.D. Pennsylvania)

• Smith v. C. R. Bard, Inc., No. 1:13-cv-00633 (E.D. Texas)

• Fox v. C. R. Bard, Inc., No. 3:14-cv-00133 (N.D. Texas)

• Henley v. C. R. Bard, Inc., No. 2:14-cv-00059 (E.D. Wisconsin)

Id^[2]

         In August 2016, the parties stipulated that remand of the mature cases should await completion of expert discovery because such discovery may be relevant in trials of the mature cases. Doc. 3214 at 3. The Court agreed, concluding that general expert disclosure and discovery, and any related Daubert motions, should be handled in this MDL. Doc. 4311 at 2. The Court further concluded that case-specific discovery in the mature cases should await their remand. Id; see Doc. 8871 at 5.

         Following the second bellwether trial earlier this year, the Court directed the parties to file memoranda addressing the appropriate time for remand of the mature cases. Doc. 11320 at 3. Defendants argued that the cases should be remanded in 2019 after completion of the remaining bellwether trials. Doc. 11550 at 5-6. Plaintiffs argued that the cases should be remanded now because retaining the cases in the MDL will provide no additional benefits and there is no reason to delay. Doc. 11553 at 7.

         The Court agrees with Plaintiffs. All common fact and expert discovery in this MDL have been completed, and the Court has ruled on Daubert motions and Defendants' summary judgment motion on preemption. The mature cases are nearly ready for trial and would no longer benefit from inclusion in this MDL. The remaining case-specific issues in the mature cases are best left to the transferor courts to resolve. The Court therefore suggests that the Panel remand the 10 mature cases listed on Schedule A to the transferor courts for further proceedings. See In re TMJ Implants, 872 F.Supp. at 1038 (suggesting remand of cases that no longer benefited from inclusion in consolidated pretrial proceedings).

         III. The MDL Proceedings.

         A summary of the MDL proceedings to date is provided below to assist the transferor courts on remand, if ordered by the Panel. Case management orders, discovery orders, and other significant rulings are listed in Exhibit 1. The status of the remaining case-specific discovery and other pretrial issues for the mature cases, and the estimated time needed to resolve such issues and make the cases ready for trial, as proposed by the parties, are listed in Exhibit 2.

         A. Case Management Orders.

         The primary orders governing pretrial management of this MDL are a series of case management orders (“CMOs”), along with certain amendments. To date, the Court has issued 36 CMOs. These orders are discussed below and can be found on the Court's website at http://www.azd.uscourts.gov/case-info/bard.

         B. Lead and Liaison Counsel.

         CMO No. 1, entered October 30, 2015, appointed Co-Lead/Liaison Counsel for Plaintiffs (“Lead Counsel”) to manage the litigation on behalf of Plaintiffs, and set out the responsibilities of Lead Counsel. Doc. 248. Plaintiffs' Lead Counsel has changed since the inception of the MDL. Mr. Ramon Lopez, of Lopez McHugh, LLP, in Newport Beach, California, and Mr. Mark O'Connor, of Gallagher & Kennedy, P.A., in Phoenix, Arizona, are now Lead Counsel for Plaintiffs. Doc. 5285. Mr. Richard North of Nelson Mullins Riley & Scarborough, LLP, in Atlanta, Georgia, is Defendants' Lead Counsel.

         C. Plaintiffs' Steering Committee and Common Benefits Fund.

         CMO No. 1 directed the selection and appointment of a Plaintiffs' Steering Committee (“PSC”) to assist in the coordination of pretrial activities and trial planning. Plaintiffs' Lead Counsel and the PSC together form the Plaintiffs' Leadership Counsel (“PLC”). The PSC acts on behalf of, and in consultation with, Plaintiffs' Lead Counsel in the management of the litigation. The PLC assists all Plaintiffs in the MDL by overseeing discovery, appearing in court, attending status conferences, and preparing motions and responses regarding case-wide discovery matters. CMO No. 1 has been amended to select and appoint a Plaintiffs' Executive Committee (“PEC”) to assist Lead Counsel in the administration, organization, and strategic decisions of the PLC. Doc. 4016. The configuration of the PSC has changed during the course of the litigation. See Docs. 248, 4016, 5285.

         CMO No. 6, entered December 18, 2015, set forth rules, policies, procedures, and guidelines for fees and expenses incurred by attorneys acting for the common benefit of all MDL Plaintiffs. Doc. 372.

         D. Master and Short-Form Pleadings.

         CMO No. 2, entered October 30, 2015, required the creation of a master complaint, a master answer, and templates of short-form complaints and answers. Doc. 249 at 6. The master complaint and answer were filed December 12, 2015. Docs. 364, 366. They are the operative pleadings for most of the cases in this MDL. The master complaint serves as a long-form complaint giving notice, pursuant to Rule 8, of the allegations that the MDL Plaintiffs assert generally. Doc. 364. The master complaint asserts 17 claims and seeks both compensatory and punitive damages. Id. ¶¶ 166-349.

         Plaintiff-specific allegations are contained in individual short-form complaints (Doc. 303-2) or certain complaints served on Defendants before the filing of the master complaint. Plaintiffs also provide Defendants with profile forms and fact sheets that describe their individual conditions and claims. Doc. 365 (CMO No. 5, as amended by Doc. 927).

         The 10 mature cases listed on Schedule A are not governed by the master complaint, but continue to be governed by the complaints and answers (including any amended pleadings) filed in the various transferor courts before the cases were transferred to this MDL. Doc. 363 (CMO No. 4, as amended by Doc. 1485). The parties were not required to exchange profile forms in the mature cases. Doc. 365.

         E. Status Conferences.

         Since the inception of the MDL, the Court has held regular status conferences with Lead Counsel for the parties to discuss issues related to the litigation. The initial case management conference was held in October 2015. Doc. 246. Deadlines were set for, among other things, the filing of master and short-form pleadings, profile forms, a proposed protective order (including Rule 502 provisions), a proposed protocol governing the production of electronically stored information (“ESI”), as well as deadlines to complete first-phase MDL discovery and address privilege log issues. Doc. 249 (CMO No. 2). Thereafter, the Court held periodic status conferences to ensure that the parties were on task and to address routine discovery issues and disputes. In addition to the status conferences, the Court conducted telephonic hearings to address time-sensitive issues, as well as numerous additional conferences to consider various matters such as hearings on dispositive motions and general case management issues.

         F. Discovery.

         1. General Fact Discovery.

         Prior to the establishment of this MDL, Plaintiffs had conducted substantial common discovery against Bard (including in the mature cases) concerning all aspects of Bard IVC filters, including the design, testing, manufacturing, marketing, labeling, and post-market surveillance of these devices. Bard produced numerous documents and ESI, responded to thousands of written discovery requests, and more than 80 corporate witness depositions were taken. The pre-MDL general fact discovery was made available by Bard to all Plaintiffs in the MDL.

         This MDL was formed to centralize pretrial proceedings and complete all common fact and expert discovery concerning Bard IVC filters. Doc. 1. CMO No. 8 established a procedure concerning re-deposing witnesses in the MDL. Doc. 519. CMO No. 14 established deposition protocols generally. Doc. 2239. The Court allowed additional depositions of a handful of corporate witnesses that had been previously deposed, as well as numerous depositions of other Bard corporate witnesses, including several Rule 30(b)(6) depositions. Docs. 3685, 4311. CMO No. 9 governed the production of ESI and hard-copy documents. Doc. 1259.

         Discovery in the MDL was separated into multiple phases. The parties completed the first phase of MDL discovery in early 2016. Doc. 519. First-phase MDL discovery included production of documents related to an FDA inspection and warning letter to Bard, an updated production of complaint and adverse event files, and an updated version of Bard's complaint database relating to IVC filters. Doc. 249. Plaintiffs also conducted a Rule 30(b)(6) deposition concerning the FDA inspection and warning letter, and a deposition of corporate witness Kay Fuller.

         The parties completed the second phase of MDL fact discovery in February 2017. CMO No. 8 set deadlines for the second phase, which included all common fact and expert issues in the MDL, but not case-specific issues to be resolved after remand. Docs. 249, 519. Second-phase discovery included extensive additional discovery related to Bard's system architecture for ESI, Bard's ESI collection efforts, ESI relating to Bard's IVC filters, and Bard's national and regional sales and marketing practices. Plaintiffs also deposed two corporate witnesses in connection with Kay Fuller's allegations that a submission to the FDA regarding the Recovery filter did not bear her original signature. Doc. 1319 (CMO No. 10). Plaintiffs deposed additional corporate witnesses concerning the FDA inspection and warning letter. Id.

         Bard also produced discovery regarding the sales and marketing materials related to the Simon Nitinol filter (“SNF”), documents comparing filter performance and failure rates to the SNF, and internal and regulatory communications relating to the SNF. Docs. 1319, 10489. The Court denied Plaintiffs' request to obtain ESI discovery from Bard's overseas operations. Doc. 3398. The Court denied Defendants' request to obtain discovery of communications between Plaintiffs' counsel and NBC related to NBC news stories about the products at issue in this litigation, and third-party financing that may be in place with respect to Plaintiffs in this MDL. Docs. 3313, 3314. Plaintiffs were required to produce communications between Plaintiffs and the FDA related to the FDA warning letter, but the Court denied Defendants' request to depose Plaintiffs' counsel regarding these communications. Docs. 3312, 4339. Bard also produced punitive damages discovery, and Plaintiffs conducted a Rule 30(b)(6) deposition related to Bard's net worth.

         All common fact discovery in these cases has now been completed. Thus, transferor courts need not be concerned with facilitating general fact discovery on remand.

         2. Case-Specific Discovery.

         The parties did not conduct case-specific fact discovery for the 10 mature cases during the MDL proceedings, but instead conducted such discovery in these cases prior to their transfer to the MDL. The Court has concluded that any additional case-specific discovery in the mature cases should await their remand. Docs. 3214 at 3, 8871 at 5. The status of the remaining case-specific discovery for the mature cases is listed in Exhibit 2.

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