Gates v. C R Bard Incorporated et al

Filing 5

CERTIFIED TRANSFER ORDER transferring case to Western District of North Carolina. (Attachments: #1 MDL Certified Docket, #2 Case Management Order, #3 Motions in Limine Orders, #4 Deposition Designation Orders, #5 Discovery and Privilege Orders, #6 Master and Short-Form Pleadings, #7 Daubert Orders, #8 Miscellaneous Orders, #9 Case Management Orders, #10 Discovery Orders)(rth)

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 1 of 72

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: Bard IVC Filters Products
Liability Litigation,

No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)

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This multidistrict litigation proceeding (“MDL”) involves personal injury cases

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brought against Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc.

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(collectively, “Bard”). Bard manufactures and markets medical devices, including inferior

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vena cava (“IVC”) filters. The MDL Plaintiffs have received implants of Bard IVC filters

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and claim they are defective and have caused Plaintiffs to suffer serious injury or death.

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The MDL was transferred to this Court in August 2015 when 22 cases had been

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filed. Doc. 1. More than 8,000 cases had been filed when the MDL closed on May 31,

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2019. Docs. 18079, 18128. Thousands of cases pending in the MDL have settled or are

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near settlement. See Docs. 16343, 19445, 19798, 21167, 21410. The remaining cases no

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longer benefit from centralized proceedings.

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On August 20, 2019, the Court suggested the remand of 35 cases that were

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transferred to this MDL by the United States Judicial Panel for Multidistrict Litigation

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(the “Panel”), and transferred more than 500 cases that were directly filed in the MDL to

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appropriate districts. Doc. 19899 at 2-6, 34-59. The Court suggested the remand of another

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case and transferred nearly 400 cases on October 17, 2019. Doc. 20672 at 2-4, 32-48. On

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March 4, 2020, the Court suggested the remand of 30 cases and transferred more than 1,000

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cases. Doc. 21462 at 2-4, 33-74 (as amended by Docs. 21463, 21472).

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In an updated report on the settlement status of cases, the parties identify more than

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100 pending cases that are not likely to settle. Docs. 21552 at 2, 21552-2. These cases –

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which were directly filed in the MDL – will be transferred to appropriate districts pursuant

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to 28 U.S.C. § 1404(a). The cases to be transferred are listed on Schedule A to this order.

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Two other cases – Bernadette McBride v. C. R. Bard, Inc., No. 2:19-cv-02819, and Lonnie

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Easton v. C. R. Bard, Inc., No. 2:19-cv-04274 – will be unconsolidated from the MDL,

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will remain in the District of Arizona, and will be assigned to the undersigned judge. See

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Doc. 21552-2 at 1, 3.

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To assist the transferee courts, this order will describe events that have taken place

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in the MDL. A copy of this order, along with the case files and materials, will be available

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to courts after transfer.

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I.

Transfer Under 28 U.S.C. § 1404(a).

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Pursuant to Case Management Order No. 4 (“CMO 4”), cases were filed directly in

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the MDL through use of a short form complaint. Doc. 363 at 3 (as amended by Docs. 1108,

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1485). Plaintiffs were required to identify in the short form complaint the district where

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venue would be proper absent direct filing in the MDL. See id. at 7. CMO 4 provides that,

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upon the MDL’s closure, each pending direct-filed case shall be transferred to the district

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identified in the short form complaint. Id. at 3.

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Section 1404(a) provides that “[f]or the convenience of parties and witnesses, in the

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interest of justice, a district court may transfer any civil action to any other district or

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division where it might have been brought or to any district or division to which all parties

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have consented.” Pursuant to § 1404(a), the Court will transfer the cases listed on Schedule

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A to the districts identified in the short form complaints. See In re Biomet M2a Magnum

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Hip Implant Prods. Liab. Litig., No. 3:12-MD-2391, 2018 WL 7683307, at *1 (N.D. Ind.

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Sept. 6, 2018) (transferring cases under § 1404(a) where they would “no longer benefit

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from centralized proceedings[] and the remaining case-specific issues are best left to

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decision by the courts that will try the cases”). Defendants’ right to challenge venue and

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personal jurisdiction upon transfer is preserved. See Docs. 19899 at 4-6, 20672 at 4, 21426

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at 4.

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II.

The MDL Proceedings.

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A summary of the MDL proceedings is provided below to assist courts receiving

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transfers under § 1404(a). CMOs, discovery orders, and other significant rulings are listed

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in Exhibit 1. The status of the remaining case-specific discovery and other pretrial issues

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in individual cases should be addressed by the transferee courts.

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A.

Plaintiffs’ Claims and the Pleadings.

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The IVC is a large vein that returns blood to the heart from the lower body. An IVC

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filter is a small device implanted in the IVC to catch blood clots before they reach the heart

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and lungs. This MDL involves multiple versions of Bard’s retrievable IVC filters – the

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Recovery, G2, G2X, Eclipse, Meridian, and Denali. These filters are umbrella-shaped

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devices that have multiple limbs fanning out from a cone-shaped head. The limbs consist

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of legs with hooks that attach to the IVC wall and curved arms to catch or break up blood

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clots. Each of these filters is a variation of its predecessor.1

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The MDL Plaintiffs allege that Bard filters are more dangerous than other IVC

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filters because they have higher risks of tilting, perforating the IVC, or fracturing and

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migrating to vital organs. Plaintiffs further allege that Bard failed to warn patients and

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physicians about these higher risks. Defendants dispute these allegations, contending that

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Bard filters are safe and effective, that their complication rates are low and comparable to

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those of other IVC filters, and that the medical community is aware of the risks associated

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with IVC filters.

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CMO 2, entered October 30, 2015, required the creation of a master complaint, a

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master answer, and templates of short-form complaints and answers. Doc. 249 at 6. The

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In early 2019, Defendants moved to expand the scope of the MDL to include cases
concerning Bard’s Simon Nitinol Filter (“SNF”), a permanent device that predated the
other filters in this litigation. The Panel denied the motion as moot because more than 80
SNF cases already had been filed in the MDL. None of the SNF cases are subject to this
order.
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master complaint and answer were filed December 12, 2015. Docs. 364, 366. They are

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the operative pleadings for most of the cases in this MDL.

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The master complaint gives notice, pursuant to Rule 8, of the allegations that

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Plaintiffs assert generally. The master complaint contains seventeen state law claims:

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manufacturing defect (Counts I and V); failure to warn (Counts II and VII); design defect

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(Counts III and IV); failure to recall (Count VI); misrepresentation (Counts VIII and XII);

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negligence per se (Count IX); breach of warranty (Counts X and XI); concealment (Count

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XIII); consumer fraud and deceptive trade practices (Count XIV); loss of consortium

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(Count XV); and wrongful death and survival (Counts XVI and XVII). Doc. 364 at 34-63.

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Plaintiffs seek both compensatory and punitive damages. Id. at 63.

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Plaintiff-specific allegations are contained in individual short-form complaints or

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certain complaints served on Defendants before the filing of the master complaint. See

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Docs. 249, 363, 365. Plaintiffs also provided Defendants with profile forms and fact sheets

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that describe their individual claims and conditions. See Doc. 365.

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B.

Case Management Orders.

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The primary orders governing pretrial management of this MDL are a series

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of CMOs, along with certain amendments. To date, the Court has issued 47 CMOs. These

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orders are discussed below and can be found on this District’s website at

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http://www.azd.uscourts.gov/case-info/bard.

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C.

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CMO 1, entered October 30, 2015, appointed Co-Lead/Liaison Counsel for

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Plaintiffs (“Lead Counsel”) to manage the litigation on behalf of Plaintiffs, and set out the

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responsibilities of Lead Counsel. Doc. 248. Plaintiffs’ Lead Counsel has changed since

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the inception of the MDL. Mr. Ramon Lopez, of Lopez McHugh, LLP, in Newport Beach,

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California, and Mr. Mark O’Connor, of Beus Gilbert McGroder PLLC, in Phoenix,

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Arizona, are now Lead Counsel for Plaintiffs. Doc. 5285. Mr. Richard North of Nelson

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Mullins Riley & Scarborough, LLP, in Atlanta, Georgia, is Defendants’ Lead Counsel.

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D.

Lead Counsel.

Plaintiffs’ Steering Committee and Common Benefits Fund.

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CMO 1 directed the selection and appointment of a Plaintiffs’ Steering Committee

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(“PSC”) to assist in the coordination of pretrial activities and trial planning. Plaintiffs’

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Lead Counsel and the PSC together form the Plaintiffs’ Leadership Counsel (“PLC”). The

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PLC assists all Plaintiffs in the MDL by overseeing discovery, appearing in court, attending

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status conferences, and preparing motions and responses regarding case-wide discovery

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matters. CMO 1 has been amended to select and appoint a Plaintiffs’ Executive Committee

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(“PEC”) to assist Lead Counsel in the administration, organization, and strategic decisions

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of the PLC. Doc. 4016. The configuration of the PSC has changed during the course of

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the litigation. See Docs. 248, 4016, 5285.

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CMO 6, entered December 18, 2015, set forth rules, policies, procedures, and

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guidelines for fees and expenses incurred by attorneys acting for the common benefit of all

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MDL Plaintiffs. Doc. 372. In May 2019, the Court increased the common benefit

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attorneys’ fees assessment from 6% to 8%, but declined to increase the 3% assessment for

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costs. Doc. 18038.

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Upon transfer, individual Plaintiffs likely will be represented by their own counsel

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– the attorney or attorneys who filed their original complaint. Plaintiffs’ Lead Counsel, the

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PSC, the PLC, and the PEC were tasked with managing the MDL for Plaintiffs, not the

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individual cases upon transfer.

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E.

Status Conferences.

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Since the inception of the MDL, the Court has held regular status conferences with

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Lead Counsel for the parties to discuss issues related to the litigation. The initial case

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management conference was held in October 2015. Doc. 246. Deadlines were set for,

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among other things, the filing of master and short-form pleadings, profile forms, a proposed

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protective order (including Rule 502 provisions), a proposed protocol governing the

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production of electronically stored information (“ESI”), as well as deadlines to complete

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first-phase MDL discovery and address privilege log issues. Doc. 249. Thereafter, the

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Court held periodic status conferences to ensure that the parties were on task and to address

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routine discovery issues and disputes. In addition to the status conferences, the Court

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conducted telephone hearings to address time-sensitive issues, as well as numerous

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additional conferences to consider various matters such as dispositive motions and general

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case management issues.

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F.

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Discovery.
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General Fact Discovery.

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Prior to the establishment of this MDL, Plaintiffs’ counsel had conducted substantial

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discovery against Bard concerning all aspects of Bard IVC filters, including the design,

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testing, manufacturing, marketing, labeling, and post-market surveillance of the devices.

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Bard produced numerous documents and ESI and responded to thousands of written

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discovery requests, and more than 80 corporate witness depositions were taken. The

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pre-MDL fact discovery was made available by Bard to all Plaintiffs in the MDL.

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CMO 8 established a procedure concerning re-deposing witnesses in the MDL.

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Doc. 519. CMO 14 established deposition protocols generally. Doc. 2239. The Court

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allowed additional depositions of a handful of corporate witnesses that had been previously

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deposed, as well as numerous depositions of other Bard corporate witnesses, including

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several Rule 30(b)(6) depositions. Docs. 3685, 4311. CMO 9 governed the production of

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ESI and hard-copy documents. Doc. 1259.

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Discovery in the MDL was separated into phases. The parties completed the first

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phase of MDL discovery in early 2016. Doc. 519. The first phase included production of

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documents related to an FDA inspection and warning letter to Bard, an updated production

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of complaint and adverse event files, and an updated version of Bard’s complaint database

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relating to IVC filters. Doc. 249. Plaintiffs also conducted a Rule 30(b)(6) deposition

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concerning the FDA inspection and warning letter, and a deposition of corporate witness

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Kay Fuller.

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The parties completed the second phase of fact discovery in February 2017. CMO 8

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set deadlines for the second phase, which included all common fact and expert issues in

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the MDL, but not case-specific issues to be resolved after remand or transfer. Docs. 249,

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519. Second-phase discovery included extensive additional discovery related to Bard’s

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system architecture for ESI, Bard’s ESI collection efforts, ESI relating to Bard’s IVC

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filters, and Bard’s national and regional sales and marketing practices. Plaintiffs also

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deposed two corporate witnesses in connection with Kay Fuller’s allegations that a

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submission to the FDA regarding the Recovery filter did not bear her original signature.

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Doc. 1319 (CMO 10). Plaintiffs deposed additional corporate witnesses concerning the

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FDA inspections and warning letter. Id.

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Bard also produced discovery regarding the sales and marketing materials related to

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the SNF, documents comparing filter performance and failure rates to the SNF, and internal

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and regulatory communications relating to the SNF. Docs. 1319, 10489. The Court denied

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Plaintiffs’ request to obtain ESI discovery from Bard’s overseas operations. Doc. 3398.

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The Court also denied Defendants’ request to discover communications between Plaintiffs’

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counsel and NBC news related to stories about the products at issue in this litigation, and

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third-party financing that may be in place with respect to MDL Plaintiffs. Docs. 3313,

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3314. Plaintiffs were required to produce communications between Plaintiffs and the FDA

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related to the FDA warning letter, but the Court denied Defendants’ request to depose

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Plaintiffs’ counsel regarding these communications. Docs. 3312, 4339. Defendants also

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produced punitive damages discovery, and Plaintiffs conducted a Rule 30(b)(6) deposition

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related to Bard’s net worth.

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All common fact discovery has now been completed, including preservation

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depositions for certain witnesses who will not be traveling to testify live at the trials of

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transferred cases. See Docs. 16343, 19959, 21063. Thus, courts receiving these cases need

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not be concerned with facilitating general fact discovery on remand or transfer.

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2.

Case-Specific Discovery.

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CMO 5 governed initial case-specific discovery and required the parties to exchange

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abbreviated profile forms. Doc. 365 (as amended by Doc. 927). Plaintiffs were required

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to provide Defendants with a Plaintiff profile form (“PPF”) that described individual

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conditions and claims.

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Defendants were required to provide the individual Plaintiff with a Defendants’ profile

Id. at 5-9.

Upon receipt of a substantially complete PPF,

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form (“DPF”) that disclosed information and documents concerning Defendants’ contacts

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and relationship with Plaintiff’s physicians, tracking and reporting of Plaintiff’s claims,

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and certain manufacturing related information for Plaintiff’s filter. Id. at 12-14. Completed

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profile forms were considered interrogatory answers under Rule 33 or responses to requests

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for production under Rule 34, and were governed by the standards applicable to written

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discovery under Rules 26 through 37. Id. at 2-3. CMO 5 also set deadlines and procedures

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for resolving any purported deficiencies with the parties’ profile forms, and for dismissal

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of cases that did not provide substantially completed profile forms. Id. at 2.2

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Further discovery was conducted in a group of 48 cases (“Group 1”) selected for

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consideration in the bellwether trial process from the pool of cases filed and properly

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served on Defendants in the MDL as of April 1, 2016 (“Initial Plaintiff Pool”). Docs. 1662,

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3214, 4311 (CMOs 11, 15, 19). Plaintiffs in Group 1 were required to provide Defendants

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with a Plaintiff fact sheet (“PFS”) that described their individual conditions and claims in

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greater detail, and provided detailed disclosures concerning their individual background,

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medical history, insurance, fact witnesses, prior claims, and relevant documents and

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records authorizations. Docs. 1153-1, 1662 at 3.

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Upon receipt of a PFS, Defendants were required to provide the individual Plaintiff

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with a Defendants fact sheet (“DFS”) that disclosed in greater detail information

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concerning Defendants’ contacts and relationship with Plaintiff, Plaintiff’s physicians, or

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anyone on behalf of Plaintiff, Defendants’ tracking and reporting of Plaintiff’s claims, sales

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and marketing information for the implanting facility, manufacturing information for

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Plaintiff’s filter, and other relevant documents. Docs. 1153-2, 1662 at 3. Completed fact

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sheets were considered interrogatory answers under Rule 33 or responses to requests for

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production under Rule 34, and were governed by the standards applicable to written

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discovery under Rules 26 through 37. Doc. 1662 at 3. CMO 11 set deadlines and

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procedures for resolving any purported deficiencies with the parties’ fact sheets. Id. at 2,

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The Court has dismissed certain cases where Plaintiffs failed to provide complete
PPFs. See Docs. 19874, 20667, 21579.
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4-5. CMO 12 governed records discovery for Group 1. Doc. 1663. The parties agreed to

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use The Marker Group to collect medical, insurance, Medicare, Medicaid, prescription,

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Social Security, workers’ compensation, and employment records for individual plaintiffs

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from third-parties designated as custodians for such records in the PFS. Id. at 1.

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From Group 1, twelve cases were selected for further consideration as bellwether

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cases (“Discovery Group 1”). Docs. 1662, 3685, 4311 (CMOs 11, 18, 19). CMO 20 set

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deadlines for preliminary case-specific discovery in that group. Doc. 4335. Pursuant to

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the protocols set in CMOs 14 and 21, the parties were permitted to depose each Plaintiff,

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his or her spouse or a significant family member, the implanting physician, an additional

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treating physician, and either a Bard sales representative or supervisor. Docs. 2239, 4866

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at 1-2. From Discovery Group 1, six Plaintiffs were selected for potential bellwether trials

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and further case-specific discovery (“Bellwether Group 1”). Docs. 1662, 3685, 4311,

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5770, 11659 (CMOs 11, 18, 19, 23, and 34).

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Except for the 48 cases in Group 1, the parties did not conduct case-specific fact

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discovery for the cases listed on Schedule A during the MDL proceedings, other than

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exchanging abbreviated profile forms. The Court concluded that any additional case-

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specific discovery in these cases should await their transfer. Thus, courts receiving these

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cases should set a schedule for the completion of case-specific discovery.

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3.

Expert Discovery.

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CMO 8 governed expert disclosures and discovery. Doc. 519. The parties

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designated general experts in all MDL cases and case-specific experts in individual

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bellwether cases. General expert discovery closed July 14, 2017. Doc. 3685 (CMO 18).

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The parties did not conduct case-specific expert discovery for the cases listed on Schedule

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A during the MDL proceedings. The Court concluded that case-specific expert discovery

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in these cases should await their transfer. Thus, courts receiving these cases should set a

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schedule for the completion of case-specific expert discovery.

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4.

Privileged Materials.

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CMO 2 required Defendants to produce privilege logs in compliance with the

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Federal Rules of Civil Procedure. Doc. 249. The parties were then required to engage in

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an informal privilege log meet and confer process to resolve any privilege disputes.

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Defendants produced several privilege logs identifying documents withheld pursuant to the

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attorney-client privilege, the work-product doctrine, and other privileges. The parties

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regularly met and conferred regarding the privilege logs and engaged in negotiations

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regarding certain entries identified by Plaintiffs. As part of that meet and confer process,

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Defendants provided Plaintiffs with a small number of these identified items for inspection

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and, in some cases, withdrew certain claims of attorney-client privilege and produced the

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previously withheld items.

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CMO 3 governed the non-waiver of any privilege or work-product protection in this

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MDL, pursuant to Federal Rule of Evidence 502(d), by Defendants’ disclosure or

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production of documents on its privilege logs as part of the meet and confer process. Doc.

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314.

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In late 2015, Plaintiffs challenged a substantial number of documents on

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Defendants’ privilege log. The parties engaged in an extensive meet and confer process,

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and Defendants produced certain documents pursuant to the Rule 502(d) order. See id.

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Plaintiffs moved to compel production of 133 disputed documents. The Court granted the

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motion in part. Doc. 2813. The parties identified several categories of disputed documents

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and provided sample documents for in camera review. The Court denied Plaintiffs’ motion

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with respect to seven of eight categories of documents and found only one of the sample

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documents in one of the categories to contain unprivileged portions that should be

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produced. The Court found all other documents protected by the attorney-client privilege

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or work product doctrine. The Court directed the parties to use this ruling as a guide to

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resolve remaining privilege disputes.

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Since this ruling, there have been no further challenges to Defendants’ privilege

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logs. Defendants continued to provide updated privilege logs throughout the discovery

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process, and the parties met and conferred to resolve privilege disputes. Privilege issues

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should not be a concern for courts that receive these cases.

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5.

Protective Order and Confidentiality.

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A stipulated protective order governing the designation, handling, use, and

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disclosure of confidential discovery materials was entered in November 2015. Doc. 269.

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CMO 7, entered January 5, 2016, governed redactions of material from additional adverse

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event reports, complaint files, and related documents in accordance with the Health

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Insurance Portability Act of 1996 (“HIPAA”) and under 21 C.F.R. § 20.63(f). Doc. 401.

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In September 2016, to expedite production of ESI, the parties agreed to a primarily

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“no-eyes-on” document production as to relevancy while still performing a privilege

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review for this expedited ESI document production. CMO 17 (Doc. 3372) modified the

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protections and requirements in the stipulated protective order (Doc. 269) and CMO 7

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(Doc. 401) for ESI produced pursuant to this process. CMO 17 was amended in November

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2016. Doc. 4015.

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Defendants filed a motion to seal certain trial exhibits at the conclusion of the first

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bellwether trial. Doc. 11010. The Court denied this motion and Defendants’ subsequent

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motion for reconsideration. Docs. 11642, 11766, 12069. Defendants also filed a motion

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to enforce the protective order for the second and third bellwether trials collectively. Doc.

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13126. This motion was denied. Doc. 14446. A list of exhibits admitted at the bellwether

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trials (excluding case-specific medical records) and documents deemed no longer subject

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to the protective order are attached as Exhibit 2.

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G.

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Six Plaintiffs were selected for potential bellwether trials. Docs. 5770, 11659

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(CMOs 23, 34). The Court held three bellwether trials: Booker, No. 2:16-cv-00474, Jones,

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No. 2:16-cv-00782, and Hyde, No. 2:16-cv-00893. The Court granted summary judgment

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in one of the bellwether cases, Kruse, No. 2:15-cv-01634, and removed another from the

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bellwether trial schedule at the request of Plaintiffs, Mulkey, No. 2:16-cv-00853. Docs.

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12202, 13329. The final bellwether case, Tinlin, No. 2:16-cv-00263, settled shortly before

Bellwether Cases and Trials.

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trial in May 2019. The Court determined that further bellwether trials were not necessary.

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Docs. 12853, 13329 (CMOs 38, 40).

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1.

Booker, No. 2:16-cv-00474.

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The first bellwether trial concerned Plaintiff Sherr-Una Booker and involved a Bard

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G2 filter. The filter had tilted, migrated, and fractured. Plaintiff required open heart

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surgery to remove the fractured limbs and repair heart damage caused by a percutaneous

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removal attempt. Plaintiff withdrew her breach of warranty claims before Defendants

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moved for summary judgment. The Court granted Defendants’ motion for summary

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judgment on the claims for manufacturing defects, failure to recall, misrepresentation,

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negligence per se, and breach of warranty. Docs. 8873, 8874. The remaining claims for

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failure to warn, design defect, and punitive damages were tried to a jury over a three-week

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period in March 2018.

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The jury found for Plaintiff Booker on her negligent failure-to-warn claim, and in

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favor of Defendants on the design defect and strict liability failure-to-warn claims.

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Doc. 10595. The jury returned a verdict of $2 million in compensatory damages (of which

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$1.6 million was attributed to Defendants after apportionment of fault) and $2 million in

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punitive damages. Id.; Doc. 10596. The Court denied Defendants’ motions for judgment

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as a matter of law and a new-trial. Docs. 10879, 11598.

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Defendants appealed, arguing that the Court erred by denying summary judgment

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on their preemption defense, that a failure-to-warn claim was unavailable, and that the

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award of punitive damages was not supported by the evidence. See Docs. 11934, 11953.

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The Ninth Circuit affirmed. See In re Bard IVC Filters Prods. Liab. Litig., No. 18-16349

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(Doc. 77), 2020 WL 4692349 (9th Cir. Aug. 13, 2020). Defendants’ petition for panel

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rehearing and rehearing en banc is pending. See No. 18-16349, Doc. 78.3

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17916.

Plaintiff filed and later dismissed with prejudice a cross-appeal. Docs. 12070,

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2.

Jones, No. 2:16-cv-00782.

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The second bellwether trial concerned Plaintiff Doris Jones and involved a Bard

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Eclipse filter. Plaintiffs withdrew the manufacturing defect, failure to recall, and breach of

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warranty claims.

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negligence per se, and unfair trade practices claims. Doc. 10404. The remaining claims

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for failure to warn, design defect, and punitive damages were tried to a jury over a

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three-week period in May 2018. The jury returned a defense verdict. Doc. 11350. Plaintiff

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filed a motion to contact the jurors, which was denied. Docs. 11663, 12068.

The Court granted summary judgment on the misrepresentation,

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Plaintiff appealed the Court’s rulings excluding cephalad migration death evidence.

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Docs. 12057, 12071. The Ninth Circuit affirmed those rulings. See In re Bard IVC Filters

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Prods. Liab. Litig., No. 18-16461 (Doc. 51), 2020 WL 4719266, at *1 (9th Cir. Aug. 13,

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2020). Plaintiff’s petition for rehearing en banc is pending. See No. 18-16461, Doc. 53.

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3.

Kruse, No. 2:15-cv-01634.

Plaintiff Carol Kruse’s case was set for trial in September 2018. The Court granted
Defendants’ summary judgment motion on statute of limitations grounds. Doc. 12202.
4.

Hyde, No. 2:16-cv-00893.

17

The third bellwether trial concerned Plaintiff Lisa Hyde and involved either a Bard

18

G2X or Eclipse filter (the exact model was in dispute). Ms. Hyde’s case was moved to the

19

September 2018 bellwether slot in lieu of Ms. Kruse’s case. Doc. 11867. Plaintiffs

20

withdrew their claims for manufacturing defect and breach of express warranty. The Court

21

granted summary judgment on the claims for breach of implied warranty, failure to warn,

22

failure to recall, misrepresentation, concealment, and fraud. Doc. 12007. The Court also

23

entered judgment in favor of Defendants on the negligence per se claim after concluding

24

that it was impliedly preempted under 21 U.S.C. § 337(a). Doc. 12589. The remaining

25

claims for design defect, loss of consortium, and punitive damages were tried to a jury over

26

three weeks in September 2018. After the close of Plaintiffs’ evidence, the Court granted

27

in part Defendants’ motion for judgment as a matter of law with respect to future damages

28

for any cardiac arrhythmia Ms. Hyde may experience, but denied the motion as to the

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1

remaining claims. Doc. 12805. The jury returned a defense verdict. Doc. 12891. Plaintiff

2

has appealed. Docs. 13465, 13480.

3

5.

Mulkey, No. 2:16-cv-00853.

4

Plaintiff Debra Mulkey’s case involved an Eclipse filter and was set for trial in

5

February 2019. Before trial, Plaintiffs asked the Court to remove the Mulkey case from

6

the bellwether trial schedule because it was similar to the Jones and Hyde cases and would

7

not provide meaningful information to the parties. Doc. 12990. The Court granted the

8

motion. Doc. 13329.

9

6.

Tinlin, No. 2:16-cv-00263.

10

The final bellwether trial concerned Plaintiff Debra Tinlin and involved a Bard

11

Recovery filter. Plaintiffs withdrew their claims for manufacturing defect, failure to recall,

12

negligence per se, and breach of warranty. The Court granted summary judgment on the

13

misrepresentation and deceptive trade practices claims. Doc. 17008. The remaining claims

14

for failure to warn, design defect, concealment, loss of consortium, and punitive damages

15

were scheduled for trial in May 2019, but the case settled.

16

H.

17

The Court has made many rulings in this MDL that could affect the remanded and

18

transferred cases. The Court provides the following summary of key legal and evidentiary

19

rulings to assist the courts that receive these cases.

20

Key Legal and Evidentiary Rulings.

1.

Medical Monitoring Class Action Ruling.

21

In May 2016, Plaintiffs’ counsel filed a medical monitoring class action that was

22

consolidated with the MDL. See Barraza v. C. R. Bard, Inc., No. 2:16-cv-01374 (D. Ariz.

23

May 5, 2015). The Barraza Plaintiffs moved for class certification for medical monitoring

24

relief on behalf of themselves and classes of individuals who have been implanted with a

25

Bard IVC filter, have not had that filter removed, and have not filed a claim or lawsuit for

26

personal injury related to the filter. Id., Doc. 54. The Court declined to certify the class.

27

Id., Doc. 95.

28

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1

The class certification motion recognized that only 16 states permit claims for

2

medical monitoring. The Court concluded that the classes could not be certified under Rule

3

23(b)(3) because individual issues would predominate. Id. at 20-21. The Court further

4

concluded that the class could not be certified under Rule 23(b)(2) because the medical

5

monitoring relief primarily constituted monetary rather than injunctive relief, and the class

6

claims were not sufficiently cohesive to permit binding class-wide relief. Id. at 21-32.

7

Finally, the Court concluded that typicality under Rule 23(a)(3) had not been established.

8

Id. at 32-34. The Barazza Plaintiffs dismissed their claims without prejudice. Docs. 106,

9

107. No appeal has been filed.

10

2.

Federal Preemption Ruling.

11

Defendants moved for summary judgment on the grounds that Plaintiffs’ state law

12

claims are expressly preempted by the Medical Device Amendments of 1976 (“MDA”),

13

21 U.S.C. § 360 et seq., and impliedly preempted by the MDA under the Supreme Court’s

14

conflict preemption principles. Doc. 5396. The Court denied the motion. Doc. 8872.

15

The MDA curtails state regulation of medical devices through a provision that

16

preempts state requirements that differ from or add to federal requirements. 21 U.S.C.

17

§ 360k. The Bard IVC filters at issue in this litigation were cleared for market by the FDA

18

through section “510k” review, which focuses primarily on equivalence rather than safety

19

and effectiveness. See § 360c(f)(1)(A).

20

The Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), held that

21

§ 360k does not preempt state law claims directed at medical devices cleared through

22

the 510(k) process because substantial equivalence review places no federal requirements

23

on a device. Id. at 492-94. Lohr also noted that the “510(k) process is focused on

24

equivalence, not safety.” Id. at 493 (emphasis in original). Although the Safe Medical

25

Devices Act of 1990 (“SMDA”), Pub. L. 101-629, injected safety and effectiveness

26

considerations into 510(k) review, it did so only comparatively. The Court found that Lohr

27

remains good law and that clearance of a product under 510(k) generally does not preempt

28

state common law claims. Doc. 8872 at 12-14.

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1

The Court further found that Defendants failed to show that the 510(k) reviews for

2

Bard IVC filters imposed device-specific requirements as needed for preemption under

3

§ 360k. Id. at 14-20. Even if device-specific federal requirements could be ascertained,

4

Defendants made no showing that any particular state law claim is expressly preempted by

5

federal requirements. Id. at 21-22.

6

The Court concluded that Plaintiffs’ state law claims are not impliedly preempted

7

because Defendants failed to show that it is impossible to do under federal law what the

8

state laws require. Id. at 22-24.

9

Defendants pursued their preemption arguments in the Booker appeal. See Docs.

10

11934, 11953. As noted, the Ninth Circuit affirmed the Court’s preemption ruling. See In

11

re Bard IVC Filters Prods. Liab. Litig., No. 18-16349, 2020 WL 4692349, at *1-6 (9th Cir.

12

Aug. 13, 2020).

13

3.

The Lehmann Report Privilege and Work Product Rulings.

14

The Court granted Defendants’ motion for a protective order to prevent Plaintiffs

15

from using a December 15, 2004 report of Dr. John Lehmann. Doc. 699. Dr. Lehmann

16

provided various consulting services to Bard at different times. Following Bard’s receipt

17

of potential product liability claims involving the Recovery filter, Bard’s legal department

18

retained Dr. Lehmann in November 2004 to provide an assessment of the risks associated

19

with the Recovery filter and the extent of Bard’s legal exposure. Dr. Lehmann prepared a

20

written report of his findings at the request of the legal department and in anticipation of

21

litigation. The Court found the report to be protected from disclosure by the work product

22

doctrine. Id. at 4-12. The Court further found that Plaintiffs had not shown a substantial

23

need for the report or undue hardship if the report was not disclosed. Id. at 13-15. The

24

Court agreed with the parties that this ruling does not alter any prior rulings by transferor

25

judges in specific cases. Id. at 22.

26
27
28

4.

Daubert Rulings.

The Court has ruled on Daubert motions directed at general experts, and refers the
remand and transfer courts to the following orders:

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1
2
3

Daubert Order

Doc. Nos.

Plaintiffs’ Expert Dr. Thomas Kinney

9428, 10323

4
5

Plaintiffs’ Experts Drs. Scott Resnick, Robert Vogelzang, 9432
Kush Desai, and Robert Lewandowski

6
7

Plaintiffs’ Experts Drs. David Kessler and Suzanne 9433
Parisian

8
9

Plaintiffs’ Experts Drs. Thomas Kinney, Anne Christine 9434
Roberts, and Sanjeeva Kalva

10
11

Plaintiffs’ Expert Dr. Mark Eisenberg

9770

Plaintiffs’ Expert Dr. Derek Muehrcke

9771

Plaintiffs’ Expert Dr. Darren Hurst

9772

16

Plaintiffs’ Expert Dr. Rebecca Betensky

9773

17

Defendants’ Expert Dr. Clement Grassi

9991, 10230

Plaintiffs’ Expert Dr. Robert McMeeking

10051, 16992

Plaintiffs’ Expert Dr. Robert Ritchie

10052

Plaintiffs’ Experts Drs. David Garcia and Michael Streiff

10072

Defendants’ Expert Dr. Christopher Morris

10230, 10231,
17285

12
13
14
15

18
19
20
21
22
23
24
25
26
27
28

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1

5.

2

Motion in Limine Rulings.
a.

FDA Evidence (Cisson Motion).

3

In the Booker bellwether trial, Plaintiffs sought to exclude, under Federal Rules of

4

Evidence 402 and 403, evidence of the FDA’s 510(k) clearance of Bard IVC filters and the

5

lack of FDA enforcement action against Bard. Doc. 9529. The Court denied the motion.

6

Docs. 9881, 10323.

7

The Court found that under Georgia law, which applied in both the Booker and

8

Jones bellwether cases, compliance with federal regulations may not render a

9

manufacturer’s design choice immune from liability, but evidence of Bard’s compliance

10

with the 510(k) process was nonetheless relevant to the design defect and punitive damages

11

claims. Doc. 9881 at 3-4. The Court acknowledged concerns that FDA evidence might

12

mislead the jury or result in a mini-trial. Id. at 5-6 (citing In re C.R. Bard, Inc., Pelvic

13

Repair Sys. Prods. Liab. Litig. (Cisson), No. 2:10-CV-01224, 2013 WL 3282926, at *2

14

(S.D.W. Va. June 27, 2013)). But the Court concluded that such concerns could adequately

15

be addressed by efficient management of the evidence and adherence to the Court’s time

16

limits for trial, and, if necessary, by a limiting instruction regarding the nature of the 510(k)

17

process. Id. at 6-7.4

18

The Court noted that the absence of any evidence regarding the 510(k) process

19

would run the risk of confusing the jury, as many of the relevant events in this litigation

20

occurred in the context of the FDA’s 510(k) review of the Bard filters and are best

21

understood in that context. Doc. 9881 at 7. Nor was the Court convinced that all FDA

22

references could adequately be removed from the evidence. Id.

23

The Court further concluded that it would not exclude evidence and arguments by

24

Defendants that the FDA took no enforcement action against Bard with respect to the G2

25

or Eclipse filters, or evidence regarding information Bard provided to the FDA in

26

connection with the 510(k) process. Docs. 10323 at 2-3 (Booker), 11011 at 4-5 (Jones).

27
28

4

The Court did not find a limiting instruction necessary at the close of either the
Booker or Jones trials. See Doc. 10694 at 9.
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1

The Court found that the evidence was relevant to the negligent design and punitive

2

damages claims under Georgia law. Id. The Court determined at trial that it had no basis

3

to conclude that the FDA’s lack of enforcement was intended by the FDA as an assertion,

4

and therefore declined to exclude the evidence as hearsay. Doc. 10568 at 87.

5

b.

FDA Warning Letter.

6

Defendants moved to exclude evidence of the July 13, 2015 FDA warning letter

7

issued to Bard. Doc. 9864 at 2-3. The Court granted the motion in part, excluding as

8

irrelevant topics 1, 2, 4(a), 4(b), 5, 6, 7, and 8 of the warning letter. Docs. 10258 at 6-8

9

(Booker), 10805 at 1 (Jones), 12736 (Hyde), 17401 at 10 (Tinlin). Topics 1 and 2 concern

10

the Recovery Cone retrieval system; Topic 4(a) concerns the filter cleaning process; and

11

Topics 4(b), 5, 6, 7, and 8 concern the Denali Filter. The Court concluded that none of

12

these topics was relevant to the issues in the bellwether cases involving a G2 filter

13

(Booker), an Eclipse filter (Jones), either a G2X or Eclipse filter (Hyde), and a Recovery

14

filter (Tinlin). Id.

15

The Court deferred ruling on the relevance of topic 3 until trial in all bellwether

16

cases. The Court found that topic 3, concerning Bard’s complaint handling and reporting

17

of adverse events with respect to the G2 and Eclipse filters, as well as the adequacy of

18

Bard’s evaluation of the root cause of the violations, was relevant to rebut the implication

19

at trial that the FDA took no action with respect to Bard IVC filters. See Doc. 10693 at 13-

20

15; Doc. 11256. The Court concluded that the warning letter was admissible under Federal

21

Rule of Evidence 803(8), and was not barred as hearsay. Doc. 10258 at 7. The Court

22

further concluded that the probative value of topic 3 was not substantially outweighed by

23

the danger of unfair prejudice to Bard under Rule 403. Id. The Court admitted the warning

24

letter in redacted form during the three bellwether trials. See Docs. 10565, 11256, 12736.

25

The Court noted that topic 3 included reference to the G2, the filter at issue in Booker, and

26

reached similar conclusions in Jones and Hyde. Doc. 17401 at 11. The parties disputed

27

the relevance of topic 3 in Tinlin because it did not include reference to the Recovery, the

28

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Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 20 of 72

1

filter at issue in Tinlin. Id. The Court did not decide this issue because the Tinlin case

2

settled.

3

c.

Recovery Cephalad Migration Death Evidence.

4

Defendants moved to exclude evidence of cephalad migration (i.e., migration of the

5

filter toward the patient’s heart) by a Recovery filter resulting in patient death. The Court

6

denied the motion for the Booker bellwether trial, which involved a G2 filter. Docs. 10258

7

at 4-5, 10323 at 4.

8

The Court granted the motion for the Jones bellwether trial, which involved an

9

Eclipse filter, and denied Plaintiff’s requests for reconsideration of the ruling before and

10

during the trial.

11

Doc. 11409 at 94-96. As noted, the Ninth Circuit affirmed the Court’s rulings. See In re

12

Bard IVC Filters Prods. Liab. Litig., No. 18-16461, 2020 WL 4719266, at *1 (9th Cir.

13

Aug. 13, 2020). Plaintiff’s petition for rehearing en banc is pending. See No. 18-16461,

14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

See Docs. 10819, 10920, 11041, 11113, 11256, 11302; see also

Doc. 53.
The Court granted the motion for the Hyde bellwether trial, which involved either a
G2X or Eclipse filter. Doc. 12533 at 6-7. Plaintiff Hyde has appealed this ruling. Docs.
13465, 13480.
The Court denied Defendants’ motion for the Tinlin bellwether trial, which involved
a Recovery filter. Doc. 17401 at 7-10. The Tinlin case settled before trial.
The Court concluded for purposes of the Booker bellwether trial that evidence of
cephalad migrations by a Recovery filter resulting in patient death was necessary for the
jury to understand the issues that prompted creation and design of the next-generation G2
filter, and thus was relevant to Plaintiff’s design defect claims. Doc. 10323 at 4. In
addition, because the Recovery filter was the predicate device for the G2 filter in
Defendants’ 510(k) submission to the FDA, and Defendants asserted to the FDA that the
G2 was as safe and effective as the Recovery, the Court concluded that the safety and
effectiveness of the Recovery filter was at issue. Id. The Court was concerned, however,
that too heavy an emphasis on deaths caused by cephalad migration of the Recovery filter –
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1

a kind of migration which did not occur in the G2 filter generally or the Booker case

2

specifically – would result in unfair prejudice to Defendants that substantially outweighed

3

the probative value of the evidence. Id. Defendants did not object during trial that

4

Plaintiffs were over-emphasizing the death evidence.

5

The Court initially concluded for purposes of the Jones bellwether trial, which

6

involved an Eclipse filter, that evidence of cephalad migration deaths by the Recovery filter

7

was inadmissible because it was only marginally relevant to Plaintiff’s claims and its

8

marginal relevancy was substantially outweighed by the risk of unfair prejudice. See Docs.

9

10819, 10920, 11041, 11113, 11256, 11302. This is because cephalad migration did not

10

continue in any significant degree beyond the Recovery filter; cephalad migration deaths

11

all occurred before the Recovery was taken off the market in late 2005; Ms. Jones did not

12

receive her Eclipse filter until 2010; the Recovery-related deaths said nothing about three

13

of Ms. Jones’ four claims (strict liability design defect and the failure to warn claims); and

14

instances of cephalad migration deaths were not substantially similar to complications

15

experienced by Ms. Jones and therefore did not meet the Georgia standard for evidence on

16

punitive damages. Docs. 10819, 11041.

17

The Court also found that deaths caused by a non-predicate device (the Recovery

18

was not the predicate device for the Eclipse in Defendants’ 510(k) submission), and by a

19

form of migration that was eliminated years earlier, were of sufficiently limited probative

20

value that their relevancy was substantially outweighed by the danger of unfair prejudice

21

because the death evidence may prompt a jury decision based on emotion. Id. The Court

22

further concluded that Plaintiff Jones would not be seriously hampered in her ability to

23

prove Recovery filter complications, testing, and design when references to cephalad

24

migration deaths are removed. Doc. 11041. As a result, the Court held that such references

25

should be redacted from evidence presented during the Jones trial.

26

The Court balanced this concern with the competing concern that it would be unfair

27

for Defendants to present statistics about the Recovery filter and not allow Plaintiffs to

28

present competing evidence that included Recovery deaths. See, e.g., Doc. 11391 at 12.

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1

Based on this concern, Plaintiffs argued at various points during the trial that Defendants

2

had opened the door to presenting evidence about Recovery cephalad migration deaths.

3

The Court repeatedly made fact-specific determinations on this point, holding that even

4

though Defendants presented some evidence that made the Recovery evidence more

5

relevant, the danger of unfair prejudice continued to substantially outweigh the probative

6

value of the cephalad migration death evidence. See Docs. 11113, 11302; see also Doc.

7

11409 at 94-96.

8

The Court concluded for purposes of the Hyde bellwether trial, which involved

9

either a G2X or Eclipse filter, that evidence of Recovery filter cephalad migration deaths

10

should be excluded under Rule 403 for the reasons identified in the Jones bellwether trial.

11

Doc. 12533 at 6-7. The Court concluded that this evidence had marginal relevance to

12

Plaintiff’s claims because Ms. Hyde received either a G2X or Eclipse filter, two or three

13

generations after the Recovery filter; Ms. Hyde did not receive her filter until 2011, more

14

than five years after cephalad migration deaths stopped when the Recovery was taken off

15

the market; the deaths did not show that G2X or Eclipse filters – which did not cause

16

cephalad migration deaths – had design defects when they left Defendants’ control; nor did

17

the cephalad migration deaths, which were eliminated by design changes in the G2, shed

18

light on Defendants’ state of mind when designing and marketing the G2X and Eclipse

19

filters. Id. at 7.

20

The Court concluded for purposes of the Tinlin bellwether trial, which involved a

21

Recovery filter, that Recovery deaths and Defendants’ knowledge of those deaths were

22

relevant to Plaintiffs’ design defect claim under Wisconsin law because they went directly

23

to the Recovery’s foreseeable risks of harm and whether it was unreasonably dangerous.

24

Doc. 17401 at 7-8. The Court also concluded that the Recovery death evidence was

25

relevant to Plaintiffs’ failure to warn and concealment claims because it was probative on

26

the causation issue – that is, whether her treating physician would have selected a different

27

filter for Ms. Tinlin had he been warned about the Recovery’s true risks, as Plaintiffs

28

describe them. Id. at 8. In addition, because this evidence would be used to impeach expert

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Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 23 of 72

1

testimony from Defendants that the Recovery filter was safe and effective, the Court

2

concluded that substantial similarity was not required. Id. at 8-9. The Court further

3

concluded that the death evidence was relevant to Bard’s state of mind and to show the

4

reprehensibility of its alleged conduct for purposes of punitive damages. Id. at 9-10. The

5

Court reached a different conclusion in the Jones and Hyde cases because cephalad

6

migration deaths stopped when the Recovery was taken off the market in 2005, and the

7

deaths shed little light on Defendants’ state of mind when marketing different, improved

8

filters years later. Id. at 9 n.4. As noted, the Tinlin case settled before trial.

9

d.

SNF Evidence.

10

Plaintiffs sought to exclude evidence of complications associated with the SNF,

11

claiming that they were barred from conducting relevant discovery into the design and

12

testing of the SNF under CMO 10. Doc. 10487; see Doc. 1319. The Court denied

13

Plaintiffs’ request. Doc. 10489. The Court did not agree that Plaintiffs were foreclosed

14

from obtaining relevant evidence for rebuttal. The Court foreclosed this discovery because

15

Plaintiffs did not contend that the SNF was defective. Id. at 2. Plaintiffs also had rebuttal

16

evidence showing that reported failure rates for SNF were lower than Recovery and G2

17

failure rates. Id. The Court ultimately concluded it would not preclude Defendants from

18

presenting its SNF evidence on the basis of a discovery ruling and permitted Plaintiffs to

19

make appropriate evidentiary objections at trial. Id. at 3.

20

e.

Use of Testimony of Withdrawn Experts.

21

Defendants sought to preclude Plaintiffs’ use at trial of the depositions of three

22

defense experts – Drs. Moritz, Rogers, and Stein – who originally were retained by Bard

23

but were later withdrawn in some or all cases. Doc. 10255 at 2. The Court denied the

24

request in part. Doc. 10382. The Court found that Defendants failed to show that the

25

depositions of these experts were inadmissible on hearsay grounds, but agreed that it would

26

be unfairly prejudicial under Rule 403 to disclose to the jury that the experts originally

27

were retained by Bard. Id. at 2-3. The Court therefore concluded that Plaintiffs could use

28

portions of the experts’ depositions that support Plaintiffs’ claims, but could not disclose

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1

to the jury that the experts originally were retained by Bard. Id. at 3. The Court was

2

concerned about the presentation of cumulative evidence, and therefore required Plaintiffs

3

to show that no other expert of similar qualifications was available or that the unavailable

4

expert had some unique testimony to contribute, before the deposition of any withdrawn

5

expert could be used at trial. Id. at 3-4.

6

f.

Other Motion in Limine Rulings.

7

Other motion in limine (“MIL”) rulings may be useful to the receiving courts. See

8

Docs. 10075, 10235, 10258, 10947. The courts are referred to the following motions and

9

orders to assist in preparing for trial:5

10
11
12
13
14
15
16
17
18
19
20
21
22
23
24

• Parties’ Joint Stipulation on MILs in Booker: The Court, on stipulation of the
parties, excluded evidence concerning several case-specific issues in the Booker
bellwether trial, as well as a few general issues, including: Bard’s 1994 criminal
conviction; other lawsuits or claims against Bard; advertising by Plaintiff’s
counsel; Plaintiff’s counsel specializing in personal injury or products liability
litigation; contingency fee agreements; and advertising by any counsel
nationally for IVC filter cases. Doc. 10235.
• Defendants MIL 1 in Booker: The Court permitted evidence and testimony
concerning Recovery complications. Doc. 10258 at 1-5; see Doc. 10819 (Jones).
As noted above, the Court permitted evidence and testimony concerning
Recovery filter cephalad migration deaths in the Booker bellwether trial
involving a G2 filter (Doc. 10323 at 4), but excluded such evidence in the trials
involving a G2X or Eclipse filter (Docs. 10819, 10920, 11041).
• Defendants’ MIL 2 in Booker: The Court permitted evidence and testimony
relating to the development of the Recovery filter. Doc. 10258 at 5-6; see
Doc. 10819 at 2-3 (Jones).
• Defendants’ MIL 4 in Booker: The Court excluded evidence and testimony
concerning a photograph of Bard employee Michael Randall making an
offensive gesture. Doc. 10075 at 1-2.
• Defendants’ MIL 5 in Booker: The Court permitted Plaintiff’s expert
Dr. Thomas Kinney to be called as a fact witness, but prohibited him from
testifying regarding his prior work for Bard as an expert witness in two prior
IVC filter cases or as a paid consultant to Bard. Docs. 10075 at 2-3, 10323 at 4.

25
26
The Court also ruled on the parties’ MILs concerning several case-specific issues.
See Docs. 10075 (Plaintiff’s MIL 12 in Booker), 10258 (Plaintiff’s’ MILs 6 and 13 in
Booker), 10947 (Defendants’ MIL 1 and Plaintiff’s MILs 1-4 and 7 in Jones), 12533
(Plaintiff’s MIL 3 in Hyde), 17285 (Plaintiff’s MIL 1 in Tinlin), 17401 (Plaintiff’s MILs
2, 3, and 6 in Tinlin).
5

27
28

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1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

• Plaintiff’s MIL 2 in Booker: The Court reserved ruling until trial on evidence
and testimony regarding the nature of Bard’s business, including the nature,
quality, and usefulness of its products, the conscientiousness of its employees,
and references to its mission statement. Doc. 10075 at 3-4.
• Plaintiff’s MIL 3 in Booker: The Court permitted evidence and testimony
concerning the benefits of IVC filters, including testimony describing Bard
filters as “lifesaving” devices. Doc. 10258 at 8.
• Plaintiff’s MIL 4 in Booker: The Court permitted evidence and testimony that
IVC filters, including Bard’s filters, are within the standard of care for the
medical treatment of pulmonary embolism. Doc. 10258 at 8-9. Defendants
agreed to not characterize IVC filters as the “gold standard” for the treatment of
pulmonary embolisms. Id. at 8.
• Plaintiff’s MIL 5 in Booker: The Court denied as moot the motion to exclude
evidence and argument relating to failure rates, complication rates, percentages,
or comparative analysis of any injuries that were not produced to Plaintiffs
during discovery, as all such information was produced. Doc. 10075 at 4.
• Plaintiff’s MIL 7 in Booker: The Court excluded evidence and argument
relating to prior judicial opinions about Plaintiffs’ experts, including the number
of times their testimony has been precluded in other cases. Id.
• Plaintiff’s MIL 8 in Booker: The Court excluded evidence and argument that
a verdict against Defendants will have an adverse impact on the medical
community, future medical device research or costs, and the availability of
medical care. Id. at 4-5.
• Plaintiff’s MIL 9 in Booker: The Court deferred ruling on the relevance of
statements or lack of statements from medical societies, including the Society of
Interventional Radiologists (“SIR”), until trial. Doc. 10258 at 14-18. The Court
ultimately admitted this evidence in both the Booker and Jones bellwether trials.
• Plaintiff’s MIL 10 in Booker: The Court excluded evidence and testimony that
Bard needed FDA consent to add warnings to its labels, send warning letters to
physicians and patients, or recall its filters. Id. at 18-19. The Court permitted
evidence and argument explaining the reasons why Bard filters were not
recalled, FDA’s potential involvement in any recall effort, and the fact that
warnings about failure rates and increased risks could not be based on MDR and
MAUDE data alone. Id.
• Plaintiff’s MIL 11 in Booker: The Court permitted evidence and argument
relating to the informed consent form signed by Plaintiff prior to insertion of the
IVC filter, even though the form is not specific to IVC filters or Bard filters.
Doc. 10075 at 5-6.
• Plaintiff’s MIL 14 in Booker: The Court reserved ruling until trial on evidence
and argument relating to background information and personal traits of Bard
employees and witnesses. Id. at 7.
• Plaintiff’s MIL 6 in Jones: The Court permitted evidence and testimony
concerning whether a party’s expert had been retained by the same attorneys in
other litigation. Doc. 10947 at 8-9.
- 25 -

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 26 of 72

• Plaintiff’s MIL 5 in Jones: The Court excluded evidence and testimony that
Bard employees or their relatives have received Bard IVC filter implants. Id. at
9-10.

1
2

• Defendants’ MIL 2 in Jones: The Court excluded evidence and testimony of
other lawsuits against Bard. Id. at 11.

3
4

• Plaintiff’s MILs 4 and 5 in Hyde: The Court permitted evidence and testimony
concerning Bard’s Instructions for Use (“IFU”) and SIR Guidelines. Doc.
12507.

5
6

• Plaintiff’s MIL 2 in Hyde: The Court permitted evidence and testimony
concerning “The Surgeon General’s Call to Action to Prevent Deep Vein
Thrombosis and Pulmonary Embolism.” Doc. 12533 at 4-6.

7
8

• Defendants’ MIL 3 in Hyde: The Court permitted evidence and testimony that
Bard’s SNF is a reasonable alternative design. Id. at 7.

9
10

• Defendants’ MIL 4 in Hyde: The Court excluded testimony from Dr.
Muehrcke about his personal feelings of betrayal and his moral and ethical issues
with Bard’s conduct. Id. at 7-8.

11
12

• Defendants’ MIL 6 in Hyde: The Court permitted evidence and testimony
regarding informed consent. Id. at 8-9.

13

• Plaintiff’s MIL 4 in Tinlin: The Court reserved ruling until trial on evidence
and argument relating to a chart created by Defendants from their internal
TrackWise database regarding reporting rates of IVC filter complications. Doc.
17401 at 5.

14
15
16

• Plaintiff’s MIL 5 in Tinlin: The Court permitted evidence and testimony
concerning a chart comparing the sales of the permanent SNF with those of
retrievable filters between 2002 and 2016. Id. at 5-6.

17
18

• Defendants’ MIL 3 in Tinlin: The Court permitted evidence and testimony
concerning the Recovery Filter Crisis Communications Plan that Bard had
prepared in 2004 to help manage damaging media coverage about a Recovery
migration death. Id. at 11-12.

19
20
21

• Defendants’ MIL 4 in Tinlin: The Court excluded evidence and testimony
concerning Dr. Muehrcke’s untimely disclosed opinion that one of his patients
died from cardiac tamponade caused by a fractured strut that had embolized to
her heart. Id. at 12-13.

22
23
24

///

25

///

26

///

27

///

28

///

- 26 -

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 27 of 72

1
2
3

6.

Deposition Designation Rulings.

The Court has ruled on numerous objections to deposition designations for trial and
refers the transferor courts to the following orders:6

4
5

Deponent

Depo. Date

Doc. No(s).

6

Bill Altonaga

10/22/2013

10497, 10922

Christine Brauer

05/23/2014

10922,

08/02/2017

10922

David Ciavarella

11/12/2013

10403

Gary Cohen

01/25/2017

10438

12

Robert Cortelezzi

11/11/2016

10438, 11064

13

Len DeCant

05/24/2016

10438, 11080

John DeFord

06/02/2016

10524, 11080

Mary Edwards

01/20/2014

10438

Robert Ferrara

04/17/2017

10438

18

Chris Ganser

10/11/2016

10438, 11073

19

Jason Greer

08/11/2014

10438, 10922

20

Janet Hudnall

11/01/2013

10403

Brian Hudson

01/17/2014

10403

John Lehmann

08/07/2014

10922

24

William Little

07/27/2016

10438, 11064

25

John McDermott

02/05/2014

10438

7
8
9
10
11

14
15
16
17

21
22
23

26
27
28

6

In addition to the depositions identified in the table above, the Court ruled on
numerous objections to case-specific deposition designations for trial.
- 27 -

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 28 of 72

1

Deponent

Depo. Date

Doc. No(s).

Patrick McDonald

07/29/2016

10486, 11064

4

Mark Moritz

07/18/2017

10922

5

Daniel Orms

08/16/2016

10403, 11073

6

Abithal Raji-Kubba

07/18/2016

11064

Gin Schulz

01/30/2014

10403

Christopher Smith

08/03/2017

11073

10

William Stavropoulos

02/01/2017

10524

11

Jack Sullivan

11/03/2016

10486,

09/16/2016

11080

2
3

7
8
9

12
13

Melanie Sussman

04/07/2017

11073

14

Mehdi Syed

03/02/2018

11313

Scott Trerotola

01/20/2017

10524

Douglas Uelmen

10/04/2013

10403, 11080

18

Carol Vierling

05/11/2016

10486, 11073

19

Mark Wilson

01/31/2017

10922

20

Natalie Wong

10/18/2016

10403

John Worland

03/16/2011

17582

15
16
17

21
22
23
24
25
26
27
28

7.

Subject Matter Jurisdiction Ruling.

The parties identified cases in the MDL for which federal subject matter jurisdiction
does not exist. Docs. 20210, 21410, 21552. No federal question jurisdiction exists under
28 U.S.C. § 1331 because the master complaint asserts no federal claim and the state law
claims alleged in the complaint do not depend on the resolution of a federal law question.
Doc. 364 ¶¶ 166-349. For purposes of diversity jurisdiction under 28 U.S.C. § 1332,
- 28 -

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 29 of 72

1

Defendant C. R. Bard, Inc. is a citizen of New Jersey and Defendant Bard Peripheral

2

Vascular, Inc. is a citizen of Arizona. See id. ¶¶ 11-12. Thus, complete diversity between

3

the parties does not exist in any case where each Defendant is a named party and Plaintiff

4

is a resident of either Arizona or New Jersey. See Doc. 20210-1.

5

Plaintiffs in most of the cases without subject matter jurisdiction agreed to a

6

dismissal without prejudice. See id. Plaintiffs in other cases opposed dismissal, but

7

provided no reason why the cases should not be dismissed. See id. The Court dismissed

8

without prejudice multiple cases for lack of subject matter jurisdiction. See Docs. 20667,

9

21461, 21579. Some of these cases may be refiled in state court. See Doc. 20210-1.

10

I.

11

Further Proceedings in Remanded or Transferred Cases.
1.

General Discovery.

12

Because all general fact and expert discovery has been completed in this MDL, the

13

courts receiving these cases need not be concerned with facilitating general expert,

14

corporate, and third-party discovery. This observation is not meant to restrict the power of

15

transferee courts for good cause or in the interest of justice to address issues that may be

16

unique and relevant in a remanded or transferred case.

17

2.

Case-Specific Discovery and Trial Preparation.

18

According to the parties, the status of the remaining discovery and other pretrial

19

issues for the cases being transferred, and the estimated time needed to resolve such issues

20

and make the cases ready for trial, will be determined after transfer. Final trial preparation

21

in the bellwether trials was governed by certain Court orders. See Docs. 8871, 10323,

22

10587, 11011, 11320, 11321, 11659, 11871, 12061, 12853, 12971.

23

J.

24

The Court has concluded that the cases listed on Schedule A should be transferred

25

to appropriate districts pursuant to 28 U.S.C. § 1404(a). Upon receipt of this transfer order,

26

the Clerk for this District shall issue a letter to the transferee courts, via email, setting out

27

the process for transferring the case. The letter and certified copy of this transfer order will

28

be sent to the transferee courts’ email addresses.

Documents to Be Sent to Transferee Courts.

- 29 -

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 31 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641
TRANSFER ORDER (FOURTH)
Schedule A – Direct-Filed Cases to Be Transferred
(September 10, 2020)

Case Caption

Case Number

Transferee District

David L. Ball v. C.R. Bard, Inc.

2:17-cv-01681

Ala. N.D.

Rickey Scott v. C.R. Bard, Inc.

2:19-cv-04063

Ala. S.D.

Nicholas Blake Norton v. C.R. Bard, Inc.

2:17-cv-01900

Ala. S.D.

Rita Rundel v. C.R. Bard, Inc.

2:19-cv-04235

Ark. E.D.

Scottie C. Wolford v. C.R. Bard, Inc.

2:19-cv-01250

Ark. W.D.

Shirely Ann Howard v. C.R. Bard, Inc.

2:17-cv-01734

Ark. W.D.

Chleora Kay Bergquist v. C.R. Bard, Inc.

2:19-cv-03942

Cal. N.D.

Alvis Edwards Deeds v. C.R. Bard, Inc.

2:19-cv-04272

Colo.

Lisa Monique Wilkins v. C.R. Bard, Inc.

2:19-cv-03932

DC

Nicole Subryan v. C.R. Bard, Inc.

2:17-cv-01729

DC

Debra Ann Skinner v. C.R. Bard, Inc.

2:17-cv-02409

DC

Sandra L. Olio v. C.R. Bard, Inc.

2:19-cv-03739

Fla M.D.

Deborah St. John, Personal Representative for
Sloan Christiansen v. C. R. Bard, Inc.

2:19-cv-03951

Fla. M.D.

Sherry Lynn Black Goodrow v. C.R. Bard, Inc.

2:18-cv-00406

Fla. M.D.

Robert Lee Felder v. C.R. Bard, Inc.

2:19-cv-03728

Fla. M.D.

Tammy Lynn Young v. C.R. Bard, Inc.

2:19-cv-03989

Fla. M.D.

Ross A. Grey v. C.R. Bard, Inc.

2:17-cv-04030

Fla. M.D.

Kenneth Ivan Holbrook v. C.R. Bard, Inc.

2:19-cv-01234

Fla. M.D.

Iarzella Marthe Dennard v. C.R. Bard, Inc.

2:19-cv-01539

Fla. M.D.

James Wesley Jordan v. C.R. Bard, Inc.

2:19-cv-04110

Fla. S.D.

Edmund Lucarelli, Jr. v. C.R. Bard, Inc.

2:18-cv-03675

Fla. S.D.

Prudence Peterson v. C.R. Bard, Inc.

2:18-cv-02090

Fla. S.D.

Theresa Melvin Mounsey v. C.R. Bard, Inc.

2:17-cv-02415

Fla. S.D.

Carmen Delia Burgos v. C.R. Bard, Inc.

2:19-cv-02898

Fla. S.D.

Steven Rogers v. C.R. Bard, Inc.

2:17-cv-04083

Ga. N.D.

1

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 32 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641
TRANSFER ORDER (FOURTH)
Schedule A – Direct-Filed Cases to Be Transferred
(September 10, 2020)

Case Caption

Case Number

Transferee District

Anthony Jackson v. C.R. Bard, Inc.

2:19-cv-01467

Ga. N.D.

Mark Daniel Dills v. C.R. Bard, Inc.

2:19-cv-01512

Ga. N.D.

Lauren Kent v. C.R. Bard, Inc.

2:19-cv-04076

Ga. S.D.

Nancy Harmon v. C.R. Bard, Inc.

2:19-cv-00721

Ga. S.D.

Linda Jenkins v. C.R. Bard, Inc.

2:18-cv-03935

Iowa N.D.

Troy McKittrick v. C.R. Bard, Inc.

2:19-cv-03231

Ill. C.D.

Karen Jandula v. C.R. Bard, Inc.

2:19-cv-02305

Ill. N.D.

Richard Jason West v. C. R. Bard, Inc.

2:19-cv-03303

Ill. N.D.

Delores Watson v. C.R. Bard, Inc.

2:17-cv-03990

Ind. S.D.

Adam Kyle Fisher v. C.R. Bard, Inc.

2:17-cv-02805

Ind. S.D.

Joanie Hansford, as Administrator of the Estate
of Michele Hansford v. C. R. Bard, Inc.

2:19-cv-01526

Kan.

Kristi G. Bailey v. C.R. Bard, Inc.

2:17-cv-04029

Ky. E.D.

Phyllis Rae Steinhoff v. C.R. Bard, Inc.

2:19-cv-03965

Ky. W.D.

Reba Carter v. C.R. Bard, Inc.

2:19-cv-01457

Ky. W.D.

Michael J. Palmer v. C.R. Bard, Inc.

2:19-cv-04227

La. E.D.

Wayne Francis Melancon, Sr. v. C.R. Bard, Inc. 2:17-cv-01733

La. E.D.

Marc J. Houle v. C.R. Bard, Inc.

2:17-cv-01705

Mass.

Kandy Carpenter v. C.R. Bard, Inc.

2:19-cv-01525

Mich. E.D.

Thomas Orest v. C.R. Bard, Inc.

2:17-cv-04095

Minn.

Naomi Gardner v. C.R. Bard, Inc.

2:19-cv-04294

Mo. W.D.

Penni Hendrickson v. C.R. Bard, Inc.

2:19-cv-04073

Mo. W.D.

Kathy Lucille Spencer v. C.R. Bard, Inc.

2:19-cv-03944

Mo. W.D.

Lisa Johnson v. C.R. Bard, Inc.

2:19-cv-02001

Mo. W.D.

Sarah Rosalie Mobley v. C.R. Bard, Inc.

2:17-cv-02239

Mo. W.D.

Sandra Risner v. C.R. Bard, Inc.

2:19-cv-02136

Miss. N.D.

2

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 33 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641
TRANSFER ORDER (FOURTH)
Schedule A – Direct-Filed Cases to Be Transferred
(September 10, 2020)

Case Caption

Case Number

Transferee District

Shari Alaine Maresh v. C.R. Bard, Inc.

2:19-cv-01632

N.C. E.D.

Kristine Louise Allsbury v. C.R. Bard, Inc.

2:19-cv-03781

N.C. M.D.

Jeremy Gates v. C.R. Bard, Inc.

2:19-cv-01498

N.C. W.D.

Nichols R. Garon v. C.R. Bard, Inc.

2:19-cv-01238

N.H.

Buntricia Bastian v. C.R. Bard, Inc.

2:19-cv-00369

Nev.

Michael Campobasso v. C.R. Bard, Inc.

2:19-cv-01575

Nev.

Carolyn Sue Cuyler v. C.R. Bard, Inc.

2:17-cv-01704

Nev.

Kevin Carenza v. C.R. Bard, Inc.

2:19-cv-03979

N.Y. E.D.

Clyde Solomon v. C.R. Bard, Inc.

2:19-cv-01466

N.Y. E.D.

Christopher Beasock v. C.R. Bard, Inc.

2:19-cv-01465

N.Y. E.D.

Jimmy Reed Dillard, Jr. v. C.R. Bard, Inc.

2:19-cv-04273

N.Y. N.D.

Marie Spencer v. C.R. Bard, Inc.

2:19-cv-04053

N.Y. S.D.

Agnes Roberts v. C.R. Bard, Inc.

2:17-cv-00138

N.Y. S.D.

Gloria Cleveland v. C.R. Bard, Inc.

2:19-cv-04179

N.Y. W.D.

Deborah S. Hamby v. C.R. Bard, Inc.

2:19-cv-01449

N.Y. W.D.

Kimberly Roberts v. C.R. Bard, Inc.

2:18-cv-02828

Ohio N.D.

Sherrie Lynn Butler v. C.R. Bard, Inc.

2:17-cv-01142

Ohio N.D.

Jeramey Kohar v. C.R. Bard, Inc.

2:19-cv-01780

Ohio S.D.

Edward Schaab v. C.R. Bard, Inc.

2:19-cv-02133

Ohio S.D.

Keyon Phillip Williams v. C.R. Bard, Inc.

2:17-cv-00606

Ohio S.D.

Keith L. Bryant v. C.R. Bard, Inc.

2:17-cv-01703

Ohio S.D.

Jessica Jean Johnson v. C.R. Bard, Inc.

2:17-cv-01706

Ohio S.D.

Adlen June Silas v. C.R. Bard, Inc.

2:17-cv-01707

Ohio S.D.

Tina M. Savage v. C.R. Bard, Inc.

2:17-cv-01731

Ohio S.D.

William Dennie Evans, III v. C.R. Bard, Inc.

2:17-cv-01816

Ohio S.D.

Lillie Elizabeth Wilburn v. C.R. Bard, Inc.

2:17-cv-02555

Ohio S.D.

3

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 34 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641
TRANSFER ORDER (FOURTH)
Schedule A – Direct-Filed Cases to Be Transferred
(September 10, 2020)

Case Caption

Case Number

Transferee District

Rudy Headley v. C.R. Bard, Inc.

2:19-cv-01497

Okla. W.D.

William Murphy v. C.R. Bard, Inc.

2:19-cv-04233

Pa. E.D.

Douglas J. Dohan v. C.R. Bard, Inc.

2:19-cv-04069

Pa. E.D.

Justin Ubel v. C.R. Bard, Inc.

2:19-cv-02073

Pa. E.D.

Rachel Evans v. C.R. Bard, Inc.

2:19-cv-04225

Pa. M.D.

Clinton Elliott Hufnagle v. C.R. Bard, Inc.

2:19-cv-03244

Pa. M.D.

Jeanette McFarland v. C.R. Bard, Inc.

2:19-cv-01511

Pa. W.D.

James O. Roberts v. C.R. Bard, Inc.

2:19-cv-03625

S.C.

Charles Ronald Finch v. C.R. Bard, Inc.

2:19-cv-01533

S.C.

Bruce R. Cunningham v. C.R. Bard, Inc.

2:19-cv-01236

Tex. E.D.

Franky Williams v. C.R. Bard, Inc.

2:19-cv-04070

Tex. N.D.

Bryon Kelly Rieken v. C.R. Bard, Inc.

2:19-cv-04061

Tex. N.D.

Dale Anthony Hall v. C.R. Bard, Inc.

2:19-cv-04058

Tex. N.D.

Alejandro G. Santana v. C.R. Bard, Inc.

2:18-cv-02264

Tex. S.D.

James Shutter v. C.R. Bard, Inc.

2:19-cv-03345

Tex. S.D.

Melissa Jane Sepeda v. C.R. Bard, Inc.

2:18-cv-01585

Tex. S.D.

Edward Lee Smith v. C.R. Bard, Inc.

2:19-cv-01630

Tex. W.D.

Charles Henry Wand v. C.R. Bard, Inc.

2:19-cv-02098

Tex. W.D.

Robert John Allsopp v. C.R. Bard, Inc.

2:19-cv-04049

Tex. W.D.

Peggy Sue Clarke v. C.R. Bard, Inc.

2:19-cv-03727

Va. E.D.

David S. Breeden v. C.R. Bard, Inc.

2:19-cv-01535

Va. E.D.

Benjamin Kwame Quarmon v. C.R. Bard, Inc.

2:17-cv-00335

Va. E.D.

Johnie W. Dalton v. C.R. Bard, Inc.

2:19-cv-04268

Va. W.D.

Norman E. Rose v. C.R. Bard, Inc.

2:19-cv-04083

Wa. W.D.

Kelly Kuester v. C.R. Bard, Inc.

2:19-cv-02904

Wis. E.D.

Jody Marie Snyder v. C.R. Bard, Inc.

2:17-cv-03272

Wis. W.D.

4

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 35 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641
TRANSFER ORDER (FOURTH)
Schedule A – Direct-Filed Cases to Be Transferred
(September 10, 2020)

Case Caption

Case Number

Transferee District

Chasity Adkins v. C.R. Bard, Inc.

2:19-cv-04261

W.V. S.D.

Angela Rhodes v. C.R. Bard, Inc.

2:19-cv-02135

W.V. S.D.

5

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 36 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 1 – MDL Orders

CASE MANAGEMENT ORDERS (CMOs)
Date Filed

Doc. No. Docket Text

10/30/2015

248

CMO 1 re Leadership Counsel Appointments

11/16/2016

4016

Amended CMO 1 re Leadership Counsel Appointments

03/21/2017

5285

Second Amended CMO 1 re Plaintiff Leadership Team

02/04/2019

15098

Third Amended CMO 1 re Plaintiff Leadership Team

10/30/2015

249

CMO 2 re Setting Deadlines, First Phase of Discovery

12/01/2015

314

CMO 3 re Non-waiver Order Pursuant to Rule 502(d)

12/17/2015

363

CMO 4 re Master Complaint, Responsive Pleadings, Short
Form Complaint, Waiver, and Answer

3/17/2016

1108

Amended CMO 4 re Master Complaint, Responsive
Pleadings, Short Form Complaint, Waiver, and Answer

4/20/2016

1485

Second Amended CMO 4 re Master Complaint, Responsive
Pleadings, Short Form Complaint, Waiver, and Answer

12/17/2015

365

CMO 5 re Plaintiff and Defendant Profile Forms

03/03/2016

927

Amended CMO 5 re Plaintiff and Defendant Profile Forms

12/18/2015

372

CMO 6 re Rules to Establishing Common Benefit Fee

01/05/2016

401

CMO 7 re Stipulations Concerning Redactions

02/02/2016

519

CMO 8 re Second Phase of Discovery

03/31/2016

1259

CMO 9 re ESI and production protocol

04/01/2016

1319

CMO 10 re Second Phase Discovery, Bellwether, ESI, FDA,
Deposition, and Privilege Log

05/05/2016

1662

CMO 11 re Bellwether Selection Process

05/05/2016

1663

CMO 12 re Joint Record Collection

06/21/2016

2238

CMO 13 re ESI, FDA Warning Letter and Designations

06/21/2016

2239

CMO 14 re Deposition Protocols
1

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 37 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

CASE MANAGEMENT ORDERS (CMOs)
Date Filed

Doc. No. Docket Text

08/25/2016

3214

CMO 15 re Lexecon Waivers, ESI Discovery, Multi-plaintiff
Actions, and Deceased Plaintiffs

08/25/2016

3215

CMO 16 re Deadlines Related to Barraza

12/02/2016

4141

Amended CMO 16 re Deadlines Related to Barraza

09/14/2016

3372

CMO 17 re Protective Order and Expedited ESI Production

11/16/2016

4015

Amended CMO 17 re Protective Order and Redactions of
Material from Expedited ESI Production

10/17/2016

3685

CMO 18 re Adjusted Discovery Schedule

12/13/2016

4311

CMO 19 re ESI and Bellwether Selection

12/22/2016

4335

CMO 20 re Discovery Deadlines for Discovery Group 1 and
Bellwether Group 1

02/06/2017

4866

CMO 21 re Discovery Protocols for Discovery Group 1

02/17/2017

5007

CMO 22 re Setting Deadlines

05/05/2017

5770

CMO 23 re Expert Deposition Deadlines, Bellwether Case
Selection, Preemption Motion for Summary Judgment, and
Mature Cases

05/19/2017

5881

CMO 23 re Discovery Protocols for Bellwether Group 1

05/19/2017

5883

Amended CMO 24 re Discovery Protocols for Bellwether
Group 1

06/06/2017

6227

CMO 25 re Bellwether Group 1 Amended Discovery
Schedule

07/17/2017

6799

CMO 26 re Depositions of Dr. Henry and Dr. Altonaga,
Communications among Plaintiffs’ Experts, and Bellwether
Trial Issues

10/10/2017

8113

CMO 27 re Privilege Issues, Bellwether Trial Schedule,
Plaintiffs’ Motion for Partial Summary Judgment, and
Recusal Unnecessary

11/21/2017

8871

CMO 28 re Booker Bellwether Trial Schedule, and Mature
Cases

2

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 38 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

CASE MANAGEMENT ORDERS (CMOs)
Date Filed

Doc. No. Docket Text

12/21/2017

9415

CMO 29 re Booker Bellwether Trial Schedule, Motion to
Certify Appeal, and Cisson Motion Briefing

01/23/2018

9775

CMO 30 re Motions Hearings, Motions in Limine, and
Punitive Damages in Booker

03/02/2018

10323

CMO 31 re Booker Trial

05/07/2018

11011

CMO 32 re Jones Trial

06/01/2018

11320

CMO 33 re Mulkey as Next Bellwether Selection, and
Mulkey Trial Schedule

06/28/2018

11659

CMO 34 re Next 3 Bellwether Trials, Kruse Trial Schedule,
Use of Dr. Kandarpa at Trial, Sixth Bellwether Tinlin,
Disposition of SNF Cases, and Remand of Mature Cases

07/13/2018

11871

CMO 35 re September, November and May Bellwether
Trials, and Hyde September Bellwether Trial Schedule

08/02/2018

12061

CMO 36 re Tinlin Bellwether Pre-trial Schedule

10/04/2018

12830

CMO 37 re Hyde Trial

10/05/2018

12853

CMO 38 re Future Bellwether Trials, February and May
Bellwether Trials, Motion to Seal Trial Exhibits, Settlement
Talks and Remand, and SNF Cases

10/16/2018

12971

CMO 39 re Tinlin Bellwether Case

11/08/2018

13329

CMO 40 re Mulkey Bellwether Trial

02/08/2019

15176

CMO 41 re Tinlin Trial, SNF Cases, Remand of Mature
Cases, and Possible Settlement Procedures

03/21/2019

16343

CMO 42 re Tinlin Trial, SNF Cases, Duplicative Cases,
Settlement Procedures and Remand or Transfer

05/02/2019

17494

CMO 43 re Tinlin Trial, Common Benefit Fund Fee and
Expense Accounts, Closing Date for New Cases and Remand
or Transfer, and SNF Cases

05/16/2020

17777

CMO 44 re Common Benefit Fund Accounts

05/31/2020

18079

CMO 45 re MDL closure

3

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 39 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

CASE MANAGEMENT ORDERS (CMOs)
Date Filed

Doc. No. Docket Text

03/27/2020

21480

CMO 46 re Common Benefit Fee and Cost Committee
(Sealed Ex Parte Order)

06/29/2020

21528

Amended CMO 46 (Sealed Ex Parte Order)

07/16/2020

21540

CMO 47 re settlement status of cases and cases dismissed
without prejudice

DISCOVERY ORDERS
Date Filed

Doc. No. Docket Text

10/30/2015

249

CMO 2 re Setting Deadlines, First Phase of Discovery

02/02/2016

519

CMO 8 re Second Phase of Discovery

03/31/2016

1259

CMO 9 re Electronically Stored Information and production
protocol

04/01/2016

1319

CMO 10 re Second Phase Discovery, Bellwether, ESI, FDA,
Deposition, and Privilege Log

05/05/2016

1663

CMO 12 re Joint Record Collection

06/21/2016

2238

CMO 13 re ESI, FDA Warning Letter and Designations

06/21/2016

2239

CMO 14 re Deposition Protocols

08/25/2016

3214

CMO 15 re Lexecon Waivers, ESI Discovery, Multi-plaintiff
Actions, and Deceased Plaintiffs

08/29/2016

3272

Order re Deposition of Jim Beasley

09/06/2016

3312

Order re discovery disputes concerning Plaintiffs’
communications with FDA

09/06/2016

3313

Order re Plaintiffs’ communications with NBC or other
media outlets and admissibility at trial

09/06/2016

3314

Order re Plaintiffs’ third party funding arrangements

09/14/2016

3372

CMO 17 re Protective Order and Expedited ESI Production

4

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 40 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

DISCOVERY ORDERS
Date Filed

Doc. No. Docket Text

11/16/2016

4015

Amended CMO 17 re Protective Order and Redactions of
Material from Expedited ESI Production

09/16/2016

3398

Order re ESI generated by foreign entities that sell filters
abroad

10/17/2016

3685

CMO 18 re Adjusted Discovery Schedule

12/13/2016

4311

CMO 19 re ESI and Bellwether Selection

12/22/2016

4335

CMO 20 re Discovery Deadlines for Discovery Group 1 and
Bellwether Group 1

12/24/2016

4339

Order re proposed depositions of and interrogatories to
Plaintiffs’ counsel

02/06/2017

4865

Order re discovery dispute on ex parte communications with
treating physicians and depositions of treating physicians and
sales representatives

02/06/2017

4866

CMO 21 re Discovery Protocols for Discovery Group 1

05/05/2017

5770

CMO 23 re Expert Deposition Deadlines, Bellwether Case
Selection, Preemption Motion for Summary Judgment, and
Mature Cases

05/19/2017

5881

CMO 23 re Discovery Protocols for Bellwether Group 1

05/19/2017

5883

Amended CMO 24 re Discovery Protocols for Bellwether
Group 1

06/06/2017

6227

CMO 25 re Bellwether Group 1 Amended Discovery
Schedule

07/17/2017

6799

CMO 26 re Depositions of Dr. Henry and Dr. Altonaga,
Communications among Plaintiffs’ Experts, and Bellwether
Trial Issues

5

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 41 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

DISCOVERY AND PRIVILEGE ORDERS
Date Filed

Doc. No. Docket Text

12/01/2015

314

CMO 3 re Non-waiver Order Pursuant to Rule 502(d)

02/11/2016

699

Order re Motion for Protective Order concerning Dr. John
Lehmann's December 15, 2004, report as protected work
product

07/25/2016

2813

Order re Plaintiffs’ Motion to Compel (Privilege Log Issues)

02/06/2017

4865

Order re discovery dispute on ex parte communications with
treating physicians and depositions of treating physicians and
sales representatives

07/17/2017

6799

CMO 26 re Depositions of Dr. Henry and Dr. Altonaga,
Communications among Plaintiffs’ Experts, and Bellwether
Trial Issues

10/10/2017

8113

CMO 27 re Privilege Issues, Bellwether Trial Schedule,
Plaintiffs’ Motion for Partial Summary Judgment, and
Recusal Unnecessary

10/20/2017

8315

Order that Plaintiffs need not produce the withheld expert
communications or provide a privilege log on these
communications to Defendants.

DAUBERT ORDERS
Date Filed

Doc. No. Docket Text

12/21/2017

9428

Order re Motion to Disqualify Plaintiffs' Expert Thomas
Kinney, M.D.

12/21/2017

9432

Order re Motion to Disqualify Plaintiffs' Experts Drs.
Resnick, Vogelzang, and Desai

12/22/2017

9433

Order re Motion to Exclude Plaintiffs' Experts Drs. Parisian
and Kessler

12/22/2017

9434

Order re Motion to Exclude Plaintiffs' Experts Drs. Kinney,
Roberts, and Kalva

01/22/2018

9770

Order re Motion to Exclude Plaintiffs' Expert Dr. Eisenberg

01/22/2018

9771

Order re Motion to Exclude Plaintiffs' Expert Dr. Muehrcke
6

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 42 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

DAUBERT ORDERS
Date Filed

Doc. No. Docket Text

01/22/2018

9772

Order re Motion to Exclude Plaintiffs' Expert Dr. Hurst

01/22/2018

9773

Order re Motion to Exclude Plaintiffs' Expert Dr. Betensky

02/06/2018

9991

Order re Motion to Exclude Bard's Expert Dr. Grassi

02/08/2018

10051

Order re Motion to Exclude Plaintiffs' Expert Dr.
McMeeking

02/08/2018

10052

Order re Motion to Exclude Plaintiffs' Expert Dr. Ritchie

02/12/2018

10072

Order re Motion to Exclude Plaintiffs' Experts Drs. Garcia
and Streiff

02/21/2018

10230

Order re Motion to Exclude Bard's Experts Drs. Grassi and
Morris

02/21/2018

10231

Order re Motion to Exclude Bard's Expert Dr. Morris

04/16/2019

16992

Order re Motion to Exclude Plaintiffs’ Expert Dr.
McMeeking

04/23/2019

17285

Order re Motion to Exclude Bard’s Expert Dr. Morris

MOTIONS IN LIMINE ORDERS
Date Filed

Doc. No. Docket Text

01/23/2018

9775

CMO 30 re Motions Hearings, Motions in Limine, and
Punitive Damages in Booker

01/26/2018

9861

Joint Stipulation re prohibiting raising certain issues in the
presence of the jury for Booker Bellwether case

01/29/2018

9881

Order re admissibility of (1) pre-market clearance of Bard
IVC filters by FDA and (2) the lack of FDA Enforcement
Action against Bard

02/15/2018

10075

Order re Motions in Limine re Photographs of Mike Randall,
Dr. Kinney work for Bard, Benevolent Activities, Evidence
Not Produced in Complaint Files, Prior Judicial Opinions,
Adverse Impact of a Plaintiff's Verdict, Informed Consent

7

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 43 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

MOTIONS IN LIMINE ORDERS
Date Filed

Doc. No. Docket Text
Form, Dr. Kang Social Media Posts, Personal Traits of
Employees and Witnesses for Booker Bellwether case

02/22/2018

10235

Order re Parties' Joint Stipulation re prohibiting raising
certain issues in the presence of the jury for Booker
Bellwether case

03/01/2018

10258

Order re Motions in Limine re Recovery® Filter
Complications, Recovery® Filter Development, FDA
Warning Letter, IVC Filter as Lifesaving Devices, IVC filters
are Gold Standard, Nonparties at Fault, Statements from
Associations and Other Groups, FDA Consent for Warnings
or Recalls for Booker Bellwether case

03/09/2018

10382

Order re Plaintiff's use of the depositions of Drs. Moritz,
Rogers, and Stein at trial

03/19/2018

10489

Order re Simon Nitinol Filter complication evidence

04/18/2018

10819

Order re reconsideration motions relating to Recovery®
Filter Evidence and cephalad Migration Deaths for Jones
Bellwether case

04/27/2018

10920

Order re Plaintiff’s motion for reconsideration of Court Order
excluding evidence of Recovery® Filter Cephalad Migration
Deaths for Jones Bellwether case

05/03/2018

10947

Order re Motions in Limine re (1) Case Specific Medical
Issues (2) Relatives receipt of IVC Filters, (3) Experts
Retained In Other Litigation, (4) Attorney Advertising, (5)
Other Lawsuits for Jones Bellwether case

05/08/2018

11041

Order re cephalad migration deaths for Jones Bellwether case

05/15/2018

11082

Order re reconsideration of Recovery migration deaths

05/29/2018

11256

Order re cephalad migration, Recovery filter and deaths and
FDA evidence for Jones Bellwether case

09/04/2018

12507

Order re SIR Guidelines and IFU for Hyde Bellwether case

09/07/2018

12533

Order re cephalad migration deaths, SNF as reasonable
alternative design, personal opinions of Dr. Muehrcke,
informed consent, FDA evidence, Surgeon General’s Call to
Action, and falling accidents for Hyde Bellwether case
8

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 44 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

MOTIONS IN LIMINE ORDERS
Date Filed

Doc. No. Docket Text

04/23/2019

17285

Order re medical care as an intervening cause of injury for
Tinlin Bellwether case

04/26/2019

17401

Order re Ms. Tinlin’s IVC Size, unrelated medical
conditions, rates of filter complications, retrievable filter
sales versus SNF sales, social security benefits, cephalad
migration deaths, FDA warning letter, crisis communications
plan, and patient at Dr. Muehrcke’s hospital for Tinlin
Bellwether case

DEPOSITION DESIGNATION ORDERS
Date Filed

Doc. No.

Docket Text

03/07/2018

10348

Order re deposition designations for Booker Bellwether case

03/12/2018

10403

Order re deposition designations for Booker Bellwether case

03/14/2018

10438

Order re deposition designations for Booker Bellwether case

03/19/2018

10486

Order re deposition designations for Booker Bellwether case

03/21/2018

10497

Order re deposition designations for Booker Bellwether case

03/26/2018

10524

Order re deposition designations for Booker Bellwether case

05/01/2018

10922

Order re deposition designations for Jones Bellwether case

05/10/2018

11064

Order re deposition designations for Jones Bellwether case

05/11/2018

11073

Order re deposition designations for Jones Bellwether case

05/14/2018

11080

Order re deposition designations for Jones Bellwether case

05/31/2018

11313

Order re deposition designations for Jones Bellwether case

08/27/2018

12357

Order re deposition designations for Hyde Bellwether case

09/04/2018

12508

Order re deposition designations for Hyde Bellwether case

09/12/2018

12590

Order re deposition designations for Hyde Bellwether case

09/13/2018

12595

Order re deposition designations for Hyde Bellwether case

09/17/2018

12598

Order re deposition designations for Hyde Bellwether case
9

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 45 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

DEPOSITION DESIGNATION ORDERS
Date Filed

Doc. No.

Docket Text

04/26/2019

17386

Order re deposition designations for Tinlin Bellwether case

05/03/2019

17513

Order re deposition designations for Tinlin Bellwether case

05/07/2019

17582

Order re deposition designations for Tinlin Bellwether case

MISCELLANEOUS ORDERS
Date Filed

Doc. No. Docket Text

11/10/2015

269

Amended Stipulated Protective Order re Confidentiality

11/22/2017

8872

Order re Bard’s Motion for Summary Judgment on
Preemption Grounds

11/22/2017

8874

Order re Bard’s Motion for Summary Judgment for Booker
Bellwether case

03/12/2018

10404

Order re Bard’s Motion for Summary Judgment for Jones
Bellwether case

03/30/2018

10587

Order re final trial preparation and setting Final Pretrial
Conference for Jones Bellwether case.

06/01/2018

11321

Order re final trial preparation and setting Final Pretrial
Conference for Mulkey Bellwether case.

06/28/2018

11659

Order re final trial preparation and setting Final Pretrial
Conference for Kruse Bellwether case.

07/13/2018

11871

Order re final trial preparation and setting Final Pretrial
Conference for Hyde Bellwether case.

07/26/2018

12007

Order re Bard’s Motion for Summary Judgment for Hyde
Bellwether case

08/02/2018

12061

Order re final trial preparation for Tinlin Bellwether case.

08/17/2018

12202

Order re Bard’s Motion for Summary Judgment for Kruse
Bellwether case

09/12/2018

12589

Order re Preemption of Negligence Per Se for Hyde
Bellwether case

10

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 46 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

MISCELLANEOUS ORDERS
Date Filed

Doc. No. Docket Text

09/13/2018

12593

Order re reconsideration of Order denying Wisconsin
Government Rules Rebuttable Presumption of Non-Defect
for Hyde Bellwether case

10/05/2018

12853

Order re amended schedule for final trial preparation and
setting Final Pretrial Conference for Mulkey and Tinlin
Bellwether cases.

10/16/2018

12971

Order re amended schedule for final trial preparation and
setting Final Pretrial Conference for Tinlin Bellwether case.

04/16/2019

17008

Order re Bard’s Motion for Summary Judgment for Tinlin
Bellwether case

05/31/2019

18038

Order re Plaintiffs Steering Committee’s Motion to Modify
CMO 6 to Increase the Common Benefit Assessments

03/04/2020

21461

Order Addressing Cases with Service of Process and Plaintiff
Profile Form Issues, Cases for Which No Federal Jurisdiction
Exists, and Duplicate Cases

07/08/2020

21527

Order re vacating dismissals of cases dismissed without
prejudice

MASTER AND SHORT-FORM PLEADINGS
Date Filed

Doc. No. Docket Text

10/30/2015

249

CMO 2 re Setting Deadlines, First Phase of Discovery

12/17/2015

363

CMO 4 re Master Complaint, Responsive Pleadings, Short
Form Complaint, Waiver, and Answer

3/17/2016

1108

Amended CMO 4 re Master Complaint, Responsive
Pleadings, Short Form Complaint, Waiver, and Answer

4/20/2016

1485

Second Amended CMO 4 re Master Complaint, Responsive
Pleadings, Short Form Complaint, Waiver, and Answer

12/17/2015

364

Master Complaint for Damages for Individual Claims

11/30/2015

302

Master Short Form Complaint for Damages for Individual
Claims

11

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 47 of 72

In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC

MASTER AND SHORT-FORM PLEADINGS
Date Filed

Doc. No. Docket Text

12/17/2015

366

Defendants’ Answer to Plaintiffs’ Master Complaint

12/17/2015

365

CMO 5 re Plaintiff and Defendant Profile Forms

03/03/2016

927

Amended CMO 5 re Plaintiff and Defendant Profile Forms

03/18/2016

1153-1

Plaintiff Fact Sheet

03/18/2016

1153-2

Defendant Fact Sheet

12

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 48 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

79

2/19/2004 Characterization of RNF - Migration resistance; TPR-04-02-02 REV 0 Test protocol for migration
resistance Characterization of RNF - Migration resistance

354

9/19/2006 PPT re G2; Caudal Movement causes tilting which leads to perforation PPT last modified 3/16/2009
(custodian Mike Randall)

443

11/30/2008 G2 and G2X Fracture Analysis Reporting date range 7/1/2005 thru 11/30/2008

447

4/1/2009 Filter - Fracture Analysis (June 2010)

495

3/26/2015 Recovery Filter System; Recovery Filter Overview

504

Eclipse Concept POA

545

Altonaga Deposition, 10/22/2013, Exhibit 03 - 2/26-2/27/2004 E-mail exchange b/w Hudnall and David Rauch of
BPV Re. "Case for Caval Centering"

546

Altonaga Deposition, 10/22/2013, Exhibit 04, Lehmann Deposition 4/2/13, Ex. 14 and Ferarra, Ex. 7, Barry
Deposition, 01/31/2014, Exhibit 18 - 4/13-4/15/2004 E-mail exchange b/w Lee Lynch, Lehmann, and others Re.
"Crisis Plan and Supporting Documents for Your Review"

552

Asch 202, 5/18/1999 Letter from Thomas Kinst, Product Manager of Filters at NMT Medical, to Monica Coutanche,
Marketing Manager at Bard Canada, Inc.

553

Asch Deposition, 05/02/2016 - Exhibit 203 - 9/14/2002 Memo from Thomas Kinst to Recovery Filter Design History
File Re. Recovery Filter Compassionate Use, Subject: "Conference call with Bard Peripheral Technologies regarding
clinical assessment of Recovery Filter removal #5"

556

Asch Deposition, 05/02/2016 - Exhibit 207 - 1/26/2001 Letter from Mount Sinai Hospital to Dr. Asch Re.
"Assessment of a New Temporary/Removable IVC Filter" - and - 11/8/2001 Letter from Mount Sinai Research Ethics
Board Re. "MSH Reference #01-0161-U

557

Asch Ex. 208, BPV-17-01-00056765 -766, /28/2000 E-mail from Paul Stagg to Cavagnaro, Mellen, Uelmen,
Vierling, and Field Re. "Fwd [2]: compassionate IVC filters" (from Asch)

559

Asch Exh. 210, BPV-17-01-00052621, 4/17/2002- Email from George Cavagnaro to Doug Uelmen and Carol
Vierling, dated April 18, 2002
1

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 49 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

561

Asch Deposition, 05/02/2016 - Exhibit 212 - Special 510(k) Submission for the Recovery Filter System, K022236,
dated 11/27/2002

563

Asch Deposition, 05/02/2016 - Exhibit 218 - Information for Use - Recovery Filter System, Dated 2004

567

Asch Deposition, 05/02/2016 - Exhibit 223 - 3/10/2003 Letter from Dr. Asch Re support for RF

571

Baird Deposition, 06/09/2016 - Exhibit 301 - PowerPoint Presentation entitled BPV Filter Franchise Review dated
5/6/2008 (colored and 43 pages)

587

Baird Deposition, 06/09/2016 - Exhibit 318 - Aug. 2010 Article by Nicholson et al. entitled "Online First: Prevalence
of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including
Cardiac Perforation and Tamponade"

588

Baird Deposition, 06/09/2016 - Exhibit 319 - 11/12/2009 E-mail from Bret Baird to Bill Little, John Van Vleet, and
Gin Schulz, with others CC’ed, Re. "Bard Filter Fractures presentation online"

589

Baird Deposition, 06/09/2016 - Exhibit 320 - ABA Project Agreement with BPV, Inc., dated 11/9/2010

590

Baird Deposition, 06/09/2016 - Exhibit 321 - 11/29-12/1/2010 E-mail exchange b/w Bret Baird and Jimmy Balwit Re.
"White Paper, Proof 2"

591

Baird Deposition, 06/09/2016 - Exhibit 322 - Bard Idea POA on the Denali Filter, Project No. 8108 Rev. 0.0, revised
August 2009 by Bret Baird

592

Baird Deposition, 06/09/2016 - Exhibit 325 - 4/28/2010 E-mail from Bret Baird to the Sales Team

614

Betensky 02/2017 Expert Report - Adverse event reports and monthly sales totals through May 2011

631

Betensky Expert Report - DFMEA070044, Rev. 3: G2 Express - Design Failure Mode and Effects Analysis

635

Betensky Expert Report - DFMEA070077, Rev. 1: Eclipse (Vail) Filter System - Design Failure Mode and Effects
Analysis

677

SOF Filter Fracture Analysis, August 2010, Reporting range 7/1/05 - 8/31/10, G2, G2X, and Eclipse

691

Boyle, 02/02/2017, Exhibit 842 - E-mail chain first one from John Van Vleet to Steve Williamson, dated 11/5/2015, 6
pages

2

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 50 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

696

Brauer Deposition, 05/23/2014 - Exhibit 16 - Testimony of Marcia Crosse, Director of Health Care, before the
Subcommittee on Health, Committee on Energy and Commerce, House of Representatives Re. "Medical Devices
¬Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing
Establishments", dated 6/18/2009

709

Brauer, 08/02/2017, Exhibit 1046 - Bard Simon Nitinol Filter, Postmarket Surveillance Study Amendment, August
10, 2014

730

Carr Deposition, 04/17/2013 - Exhibit 01 - Class of Plaintiffs' Notice of Taking Rule 30(b)(6) Deposition Duces
Tecum in Case No. 12-80951- CIV-ROSENBAUM

735

Carr Deposition, 04/17/2013 - Exhibit 07 - Bard Idea POA - Eclipse Anchor Filter, caudal migration, Rev 0, 4/1/2010
E-mail exchange b/w Tracy Estrada and Ed Fitzpatrick

737

Carr Deposition, 04/17/2013 - Exhibit 09 - 8/22-8/25/2008 E-mail exchange b/w Bret Bard, Mike Randall, and
Natalie Wong Re. "[Redacted] Conference call - complaint on fracture"

755

Carr Deposition, 10/29/2014 - Exhibit 3A - E-mail exchange b/w Hudnall and others from 3/9-10/4/2005 Re. "Special
Accounts Roadshow"

764

REDACTED

Carr Deposition, 11/05/2013 - Exhibit 14 - 5/27/2004 E-mail b/w Greer, Carr, Hudnall, and Sullivan re. "Bariatric
patients and filters", "Stay out of the buffet line", BPVE-01-00010858 -859

769

Carr Deposition, 12/19/2013 - Exhibit 05 - BPV Meridian Claims Matrix, dated 7/2/2010

770

Carr Deposition, 12/19/2013 - Exhibit 06 - Bard's Denali Concept Product Opportunity Appraisal, POA-8108, Rev.
1.0

800

Carr Deposition, 12/19/2014 - Exhibit 18 - NMT RNF PDT Meeting Notes re Product Development Team,
01/13/1998

802

Carr Deposition, 12/19/2014 - Exhibit 20 - NMT R&D Technical Report, RD-RPT-128, 09/01/2000, Investigation
Report of a Migrated Recovery Filter in the Human Use Experience at Mt. Sinai Hospital

854

REDACTED

Carr Deposition, November 5, 2013 - Exhibit 15 - 12/12/2004 E-mail from Uelmen to Kellee Jones, attaching
12/9/2004 Remedial Action Plan (Revised) SPA-04-12-01

3

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 51 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

876

Chanduszko Deposition, 04/23/2015 - Exhibit 17 - Pages 30-44 of Notebook No. 7013, Project: Recovery Filter Arm
Fatigue Testing

905

Ferrara Exh. 19, BPVE-01-00245186 -188, Email chain re G2 Caudal Migrations 12/27/2005

922

Ciavarella Deposition, 11/12/2013 - Exhibit 22 - Chart of Sales and Adverse Events for all competitors from Q3/00
through Q2/03, according to the MAUDE database.

923

Ciavarella Deposition, 11/12/2013 - Exhibit 24 - Summary of Sales and Adverse Events for all competitors from
01/00 through Q1/04

924

Ciavarella Deposition, 11/12/2013 - Exhibit 26 - Chart of Sales and Adverse Events for all competitors from 01/00
through Q1 2006, according to the MAUDE database.

925

Ciavarella Deposition, 11/12/2013 - Exhibit 28 - PowerPoint presentation entitled "Filters Complaint History Data as
of 7/31/2007" by Natalie Wong.

926

REDACTED

Ciavarella Deposition, 11/12/2013 - Exhibit 31 - 8/3/2005 Memo from C. Ganser to T. Ring/J. Weiland Re. IVC
Recovery Filter Adverse Events (Migrations/Fractures)

927

Ciavarella Deposition, 11/12/2013 - Exhibit 35 - Health Hazard Evaluation Memo from Ciavarella to Uelmen Re.
"Recovery Filter - Consultant's report", dated 12/17/2004

931

Ciavarella Deposition, 11/12/2013 - Exhibit 39 - Draft of Updated Health Hazard Evaluation Memo from Ciavarella
to Uelmen, re: "Limb Fractures of Recovery Filter", dated 7/9/2004.

932

SWOT Analysis; 5/6/2008 PowerPoint presentation entitled "Filter Franchise Review" BPVE-01-00622862 - 900

945

Cohen Exh. 736, BPVE-01-00074004 - 006, IVC Filters - Covered Stents, Monthly Report April, 2004

965

Cohen Exh. 757, BPVEFILTER-01-00148562, E-mail dated 12/15/04, with attached FDA Filter Information, FDA
called Temple to speak with Cohen

991

Cortelezzi, 11/11/2016, Exhibit 586 - 12/23/2005 E-mail from David Ciavarella Re. "G2 Caudal Migrations",
forwarded to Brian Barry on 12/27. Worst case consequence of migrations - accompanied in a majority of tilt cases.
Would like to now look at G2 complaints.

4

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 52 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

992

Cortelezzi, 11/11/2016, Exhibit 588 - 7/16/2005 E-mail from Jason Greer to many Re. "Westy's situation…everyone's
situation", detailing Bard's need to respond to Cordis' bringing forward the Maude database to physicians and
"causing a problem"

994

D'Ayala Exh. 4, G2 Filter System for Permanent Placement, IFU, G2 Filter System, 10/2006, Rev. 5, PK5100030,
BPV-17-01-00137425 - 432 (also used with Muehrcke)

1001

D'Ayala Exh. 13, Evidence-Based Evaluation of Inferior Vena Cava Filter Complications Based on Filter Type

1006

DeCant Deposition, 05/24/2016 - Exhibit 254 - 12/9/2003 Meeting Minutes Memo from Brian Hudson to Len
DeCant, Mike Casanova, Robert Carr, and Alex Tessmer Re. "Special Design Review for Recovery (Project #'s 7081
and 8008)"

1009

REDACTED

DeCant Deposition, 05/24/2016 - Exhibit 258 - 4/6/2004 Memo from Peter Palermo to Doug Uelmen Re. "Remedial
Action Plan - BPV Recovery Nitinol Vena Cava Filter", including the Remedial Action Plan SPA 04-03-01 on the
Recovery Filter, dated 3/26/2004

1014

REDACTED

DeCant Deposition, 05/24/2016 - Exhibit 264 - 6/11/2004 Memo from Pete Palermo to Doug Uelmen Re. "Remedial
Action Plan - BPV Recovery Filter - Migration"

1018

REDACTED

DeCant Deposition, 05/24/2016 - Exhibit 268 - 9/27/2004 Memo from Pete Palermo to Doug Uelmen Re. "Remedial
Action Plan - BPV Recovery Filter - Migration (SPA-04-05-01)"

1022

REDACTED

DeCant Deposition, 05/24/2016 - Exhibit 274 - Failure Investigation Report on the Recovery Filter Migration, FIR04-12-01 Rev. 00

1023
1031
1036

DeCant Deposition, 05/24/2016 - Exhibit 275 - Internal Presentation on the G2 Filter System for Permanent Use,
detailing the design modifications, features/benefits, and comparison to the Recovery Filter
REDACTED

Deford Deposition, 06/02/2016 - Exhibit 283 - BPV File on The Recovery Filter Migration, including Minutes from
the 2/12/2004 Migration Meeting
Deford Deposition, 06/02/2016 - Exhibit 296 - 9/26-9/27/2007 High Importance E-mail exchange b/w Dennis
Salzmann, John Van Vleet, and John Reviere of BPV, with others CC’ed, Re. "Comments on Rev H". Discussion
about concern for over-reporting of the SIR guidelines re- classification and removal of the retroperitoneal bleed, and
replacing consultant John Lehmann
5

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 53 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

1053

Edwards Deposition, 01/20/2014 - Exhibit 02 - 3/28/2003 Document RE. "Product Opportunity Appraisal for
Recovery Filter", FM070018, Doc No. POA-7081, Version 000

1062

BPV PowerPoint presentation entitled "BPV/AngioMed New Product Development Review Meeting - April 26,
2004"

1130

Ferrara Exh. 3, Email Chain from Regina Busenbark to Robert Ferrara 1-12-2006

1133

Ferrera Deposition, 04/07/2017, Exhibit 11 - Recovery Filter Arm Fracture, Remedial Action Plan September 2, 2004

1140

REDACTED

Ferrera Deposition, 04/07/2017, Exhibit 25 - Presentation titled Filter-Fracture Analysis

1149

Fuller Deposition, 01/11/2016 - Exhibit 123 - NMT Report Entitled "Line Extension to the Simon Nitinol
Filter®/Straight Line System, To Be Referred As: TRADEMARK Retrievable Filter"

1211

Ganser Deposition, 10/11/2016 - Exhibit 516 - 21 U.S.C.A. § 351, Adultered Drugs and Devices, Effective 7/9/2012

1214

REDACTED

1216

Ganser Deposition, 10/11/2016 - Exhibit 523 - Several memos: (1) 12/8/2004 BPV Memo from John McDermott to
Tim Ring and John Weiland Re. "Monthly Global PV Report - November 2004"; (2) 12/8/2005 BPV Memo from
John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report - November 2005; (3) 2/10/2006
BPV Memo from John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report - January 2006;
and (4) 2/8/2007 BPV Memo from John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report
- January 2007
Ganser Deposition, 10/11/2016 - Exhibit 526 - Regulatory Affairs Manual Re. "Product Remedial Actions", RASTD-002 Rev. 08, dated 10/12/2000

1219

REDACTED

Ganser Deposition, 10/11/2016 - Exhibit 529 - 6/30/2004 Updated Health Hazard Evaluation from David Ciavarella,
M.D. to Doug Uelmen Re. "Migration of Recovery Filter"

1220

REDACTED

Ganser Deposition, 10/11/2016 - Exhibit 530 - 8/25/2004 E-mail from Avijit Mukherjee to Robert Carr, Janet Hudnall
CC’ed, Re. "Recovery Filter objective statement", proposing one objective statement for the Recovery Filter G1A
project, which Hudnall thought sounded "great"

1221

REDACTED

Ganser Deposition, 10/11/2016 - Exhibit 533 - 2/15/2006 Health Hazard Evaluation from David Ciavarella to Gin
Schulz Re. "G2 Inferior Vena Cava Filter - Migration"

6

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 54 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.
1222

Notes
REDACTED

Description
Ganser Deposition, 10/11/2016 - Exhibit 534 - PowerPoint Presentation for a meeting to analyze EVEREST and
MAUDE data and provide justifications for proposed changes to G2 filter

1295

Graves Deposition, 02/27/2014 - Exhibit 10 - 3/23/2006 E-mail exchange b/w Mickey Graves and Charlie Simpson,
FEA on G2, regarding Historical FEA analysis

1335

Hudnall Deposition, 11/01/2013, Exhibit 21 - Brochure - Recovery Cone Removal System

1336

Hudnall Deposition, 11/01/2013, Exhibit 22 - Recovery G2 Filter System brochure

1337

Hudnall Deposition, 11/01/2013, Exhibit 23 - G2 Brochure (permanent) - Patient Questions & Answers and Bard's
website page about G2 Filter System, Indicated for removal, 6/10/2010

1339

REDACTED

Hudnall Deposition, 11/01/2013, Exhibit 29 - 7/6/2004 E-mail exchange b/w Hudnall and Bob Cortelezzi Re. "Maude
Website Discussion"

1369

Hudson Deposition, 01/17/2014 - Exhibit 16 - 3/24/2004 E-mail from Alex Tessmer to Charlie Benware and Ed
Fitzpatrick Re. "Starguide Filter Migration Test Results"

1370

Hudson Deposition, 01/17/2014 - Exhibit 18 - 12/11/2003 E-mail exchange b/w Brian Hudson and Janet Hudnall,
others CC’ed, Re. "Special Design Review for Recovery - Meeting Minutes".

1383

Hudson Deposition, 01/17/2014, Exhibit 13 - BPV Engineering Test Report - Characterization of Recovery Filter
Migration Resistance in Comparison to Competitive Product - Phase 1, ETR-04-03-02, Rev 0.

1500

Kessler Report - August 7, 2010, John Van Vleet emailed BPV President Jim Beasley, Marketing Director Bill Little,
and V.P. of QA Gin Schulz

1517

EVEREST Track wise and MAUDE PowerPoint, BPV-17-01-00188507

1568

Kessler Report - September 30, 2010 memo from Brett Baird to Eclipse DRT, with the subject line “Eclipse PostMarket Design Review/Marketing Summary,” stated: “The objective of the Eclipse Filter project was to enhance the
G2 X filter surface finish…"

1578

ETR-06-28-29, revision 0, project #8049, Caudal Migration Test Method Development and G2 Filter Resistance Test
Report, 11/27/06, BPVE-01-00789532

7

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 55 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

1580

REDACTED

Kessler Report -July 12, 2004 email from Bard’s VP of Regulatory Sciences Chris Ganser, to Tim Ring and John
Weiland, attached “an executive summary of Recovery Filter adverse events (migration and fracture”

1594

REDACTED

Lehmann Deposition, 04/02/2013 - Exhibit 08 - 2/16/2005 E-mail from Charlie Simpson to Hudnall Re. "American
Venous Forum - Mary Protocor presented an evaluation of filter related findings from the Maude database"

1612

Lehmann Deposition, 08/07/2014, Exhibit 08 - Updated Health Hazard Evaluation Memo from Ciavarella to Uelmen,
re: "Limb Fractures of Recovery Filter", dated 7/9/2004

1613

Lehmann Deposition, 08/07/2014, Exhibit 09 - 6/10/2004 E-mail exchange b/w Ciavarella and Cindi Walcott Re.
"Recovery Filter/Detachments"

1616

Little Deposition, 06/27/2016 - Exhibit 2003 - "Patient Questions & Answers" Brochure for the G2 Filter System

1617

Little Deposition, 06/27/2016 - Exhibit 2004 - Chart entitled "EVEREST/Cook Celect Clinical Comparison"

1618

Little Deposition, 06/27/2016 - Exhibit 2005 - 4/27/2010 BPV Memo from Filter Marketing to Bill Little Re. "Filter
naming", detailing the name rational for the Eclipse and Denali

1621

Little Deposition, 06/27/2016 - Exhibit 2009 - "Fractures of a Nitinol IVC Filter" presentation by Dr. W. Jay
Nicholson on www.CRTonline.org, in which he reviewed a single center experience on fractures with the Bard
Recovery and G2 filters

1643

McDermott Deposition, 02/05/2014 - Exhibit 02 - Bard's Product Performance Specification Report on the Recovery
Filter and Femoral Delivery System, PPS No. PPS070016 Rev. 0

1680

REDACTED

McDonald Deposition, 07/29/2016 - Exhibit 21 - 7/13/2015 Warning Letter from the FDA regarding the 11/25/2014
Inspection of the C.R. Bard facility in NY and the 11/18/2014-1/5/2015 Inspection of the BPV facility in AZ

1740

Modra Deposition, 06/06/2014 - Exhibit 5 - 1/18/2010 E-mail from Bret Baird (Marketing Manager of IVC Filters) to
Sales Team list serve (TPE-PV Sales-DG) Re. "Important: Eclipse Vena Cava Filter Launch Details"

1742

Modra Deposition, 06/06/2014 - Exhibit 7 - Product Opportunity Appraisal for the G2 Platinum Concept, POA-8088
Rev. 1.0, Revised on 5/5/2009

1763

Modra, 01/26/2017, Exhibit 771A - Chart entitled "Design Failure Mode and Effects Analysis" on the Simon Nitinol
Filter - SNF/SL Filter Sets (DFMEA070042 Rev. 1)
8

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 56 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

1787

Orms Deposition, 08/16/2016 - Exhibit 13 - 11/9/2010 E-mail Thread from Chris Smith Re. "Northside(S) Filter
Business"

1788

Orms Deposition, 08/16/2016 - Exhibit 14 - 10/2/2010 E-mail Thread from Jeffrey Pellicio Re. "Meridian
Commercialization Plan"

1817

Raji-Kubba Deposition, 07/18/2016 - Exhibit 301 - 5/14/2009 E-mail from Bill Edwards to Raji-Kubba and Mike
Randall Re. "Tomorrow"

1821

Raji-Kubba Deposition, 07/18/2016 - Exhibit 305 - 11/12/2009 E-mail from Bret Baird to Bill Little, John Van Vleet,
and Gin Schulz

1822

Raji-Kubba Deposition, 07/18/2016 - Exhibit 307 - 1/21/2010 Bard Memo from Jeffrey Pellicio to "Reviewers"

1823

Raji-Kubba Deposition, 07/18/2016 - Exhibit 308 - 1/4/2010 E-mail from Gin Schulz to Beasley, Raji-Kubba, Van
Vleet, Doherty, and Little Re. "Potential Actions"

1825

Raji-Kubba Deposition, 07/18/2016 - Exhibit 310 - 9/1/2009 E-mail from Mike Randall Re. "0809 Filters Monthly
Report.doc"

1861

Only admitted
Pgs. 38 & 70

Randall, 01/18/2017, Exhibit 634 - Binder labeled "Meridian Design History File DHF, Vol. II"

1912

Romney Deposition, 09/07/2016 - Exhibit 2039 3/16/2006 E-mail from Jason Greer to Janet Hudnall

1926

Romney, 01/18/2017, Exhibit 2061 - 8/6/2014 E-mail from Schyler Smith, Field Manager for BPV in WashingtonIdaho-Montana, to Kim Romney, Subject redacted, relaying that a redacted doctor had placed a Meridian in the past
year and discovered at retrieval that an arm fractured, which imaging confirmed had occurred within 1 week of
placement, and was now wondering if he should try to remove the filter or leave it in. Van Vleet forwarded to
Treratola in a high importance e-mail on 8/7, requesting that he contact the doctor on Bard's behalf.

1940

REDACTED

Schulz Deposition, 01/30/2014 - Exhibit 11 - Chart of Adverse Events and Deaths for all competitors from Prior
Evaluation through Q3 2005 and from

1941

REDACTED

Schulz Deposition, 01/30/2014 - Exhibit 12 - 11/30/2005 E-mail exchange b/w Gin Schulz and Kellee Jones re Gin,
G2 v. Maude and attachments, Spread Sheet - Filter Sales (IMS Q1 '00 to Q4 '04, + Trend Q1 - Q3 '05)

9

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 57 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

1944

Schulz Deposition, 01/30/2014 - Exhibit 15 - 5/19/2006 E-mail from Natalie Wong to Gin Schulz and Candi Long,
attaching the PowerPoint Presentation on "Recovery (Gen 1) Fracture Slides" (included in exhibit) and RNF Fracture
Report (not included), updated to be current as of 5/18/2006 for the Management Review

1945

Schulz Exh. 16, BPVEFILTER-01-00008798 - 851, 10/1/2006 E-mail from Natalie Wong to Several Re. "Fracture
Docs"

1946

Schulz Deposition, 01/30/2014 - Exhibit 17 - 2/2/2006 E-mail from Gin Schulz to Several Re. "Minutes"

1947

Schulz Deposition, 01/30/2014 - Exhibit 19 - 5/10/2006 E-mail from Natalie Wong Re. "FDA Proposed Response"

1948

Schulz Deposition, 01/30/2014 - Exhibit 2 - 1/31/2006 E-mail from Gin Schulz to Mickey Graves and Natalie Wong
Re. "Caudal"

1949

Schulz Deposition, 01/30/2014 - Exhibit 21 - 6/28/2011 Email Chain from Brian Hudson to Kevin Bovee and Chad
Modra Re Talking Points Including attachment

1950

Schulz Deposition, 01/30/2014 - Exhibit 4 - Meeting Summary of the IVC Filter Focus Group meeting held on
6/1/2006 in Chicago, IL at Hilton O'Hare

1951

Schulz Deposition, 01/30/2014 - Exhibit 5 - 1/31/2005 Memo from Peter Palermo to Kerry Chunko Re. "Quality Plan
2005"

2045

Sullivan Deposition, 09/16/2016 - Exhibit 431 - Marketing Brochure - G2 Filter System for Permanent Placement

2048

REDACTED

Sullivan Deposition, 09/16/2016 - Exhibit 437 - Document entitled "Failure Investigations/R002 History Review"

2049

Sullivan Deposition, 09/16/2016 - Exhibit 439 - 11/17/2004 Updated Health Hazard Evaluation Memo from David
Ciavarella, M.D. to Doug Uelmen, Re: "Limb Fractures of Recovery Filter"

2052

Wong Exh. 546, BPVE-01-01239757 - 775, Draft of PowerPoint Presentation entitled "G2 and G2X Fracture
Analysis", dated 11/30/2008

2057
2059

REDACTED

Sullivan, 11/03/2016, Exhibit 442 - Recovery Filter Migration Remedial Action Plan SPA-04-12-01 dated 1/4/2005,
including the Lehmann Report and Dr. Ciavarella's 12/17/2004 HHE titled "Recovery Filter - Consultant's report"
Tessmer Deposition, 06/12/2013 - Exhibit 02 - Project Status Report Form for the Recovery Filter, Project No. 7081,
initiated 7/1/2002 with the goal to "Investigate Migration"; FM0700160, Rev. 1
10

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 58 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

2061

Tessmer 5, BPVE-01-00000230, 2/4/2004 E-mail from Alex Tessmer to Several Re. "Updated: Filter Migration Flow
Loop Test Fixture"

2062

Tessmer Deposition, 06/12/2013 - Exhibit 07 - 1/14/2004 Memo from Rob Carr to File Re. "Design Review Meeting
Minutes Response"

2063

Tessmer Deposition, 06/12/2013 - Exhibit 08 - 2/25/2004 E-mail from Alex Tessmer to Robert Carr and Brian
Hudson Re. "Filter Migration Test Results

2065

Tessmer Deposition, 06/12/2013 - Exhibit 11 - BPV Engineering Test Report - Characterization of Recovery Filter
Migration Resistance When Legs are Crossed or Hooks Removed - Phase 2, ETR-04-03-10, Rev 0

2068

Tessmer Deposition, 06/12/2013 - Exhibit 17 - 6/8/2004 "High" Importance E-mail from Alex Tessmer to Carr,
Chanduszko, and Hudson Re. "Filter Improvement DOE"

2069

Tessmer Deposition, 06/12/2013 - Exhibit 19 - 8/26/2004 E-mail from Alex Tessmer to Robert Carr and Avijit
Mukherjee Re. "Corporate Presentations"

2090

Tillman, 08/04/2017, Exhibit 1064 - NMT PowerPoint, Cprdos, 06/14/2000

2105

Trerotola, 01/20/2017, Exhibit 692 - 4/30/2015 E-mail from Dr. Trerotola to John Van Vleet, forwarding an article
from Forbes Magazine about ALN filters entitled "Effect of a Retrievable IVC Filter Plus Anticoagulation vs.
Anticoagulation Alone on Risk of Recurrent PE: A Randomized Clinic Trial". Per Trerotola, "not good for ALN...and
maybe not good for the industry". The article was discussed through 5/4, as they were meeting that day to review
articles before meeting with JVV.

2149

Vierling Deposition, 05/11/2016 - Exhibit 231 - 12/13/2001 E-mail from Carol Vierling to [e-mail], Paul
Stagg, and Connie Murray Re. "RF Protocol"

2153

Vierling Deposition, 05/11/2016 - Exhibit 236 - 6/3/2002 Memo from Lynn Buchanan-Kopp to Project 7081 Design
History File Recovery Filter Project Team Re. "Project Phase Clarification", defining the 3 phases of the Recovery
filter project (I. Permanent; II. Intraprocedural Removal; and III. Long-Term Removable), as decided at the project
team meeting on 5/20/2002

2217

Williamson Deposition, 09/07/2016 - Exhibit 105 - Cover page entitled "Attachment 1.14", followed by the
1/23/2015 Memo from Ludwig to Chad Modra Re. "IVC Filters Retrospective Review", detailing the 2-year review
11

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 59 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description
of 939 filter complaints from 1/2013 to 1/2015, with a chart detailing whether the MDR classification changed for
any complaints

2238

Wilson, 01/31/2017, Exhibit 801 - E-mail string, Subject: Meridian Commercialization Plan

2243

Wong Deposition, 10/18/2016 - Exhibit 537 - 4/23/2004 E-mail from John Lehmann to Carr and Uelmen Re. "Draft
data set for statistician"

2244

REDACTED

Wong Deposition, 10/18/2016 - Exhibit 538 - 12/17/2004 Health Hazard Evaluation from David Ciavarella to Doug
Uelmen Re. "Recovery Filter - Consultant's Report", detailing the 76 reports of the Recovery filter, with 32 serious
injury and 10 deaths of the 20,827 units sold during the reporting period

2245

Wong Exh. 540, Recovery Gen 1, Fracture and Migration Complaint Update, 6-20-2006

2245

Wong Deposition, 10/18/2016 - Exhibit 540 - Confidential PowerPoint Presentation entitled "Recovery (Gen 1) Fracture and Migration Complaint Update," dated 6/20/2006

2246

Wong Exh. 541, BPVE-01-01512188, Email from Natalie Wong to Gin Schulz Re RNF Fracture Report 8-1-06, 8-42006

2247

Wong Deposition, 10/18/2016 - Exhibit 542 - 12/2/2009 E-mail exchange b/w Sandy Kerns and Natalie Wong Re.
"Filter Fractures"

2248

Wong Deposition, 10/18/2016 - Exhibit 543 - PAT PowerPoint Presentation entitled "G2 Caudal Migration Update,"
dated 3/2/2006, which Wong circulated via e-mail on 3/2/2006 to several for the presentation that afternoon

2249

Wong Deposition, 10/18/2016 - Exhibit 544 - 5/18/2006 Natalie Wong meeting documents, email re "Caudal
Investigation" with attachments of G2 Caudal Report 05.18.06 and Caudal Pre-PAT minutes

2250

Wong Deposition, 10/18/2016 - Exhibit 545 - BPV's Failure Investigation Report on the G2 Filter - Caudal Migration,
FIR-06-01-01, unsigned and forwarded by Wong to Gin Schulz for her review, in anticipation of the Friday deadline

2251

Wong Deposition, 10/18/2016 - Exhibit 547 - 4/10/2006 High Importance E-mail from Cindi Walcott to Allen,
Schulz, and McDermott Re. "FW: FDA Request for Information"

2252

Wong Deposition, 10/18/2016 - Exhibit 548 - 9/25/2007 E-mail from John Lehmann to John Van Vleet and John
Reviere Re. "EVEREST FSR rev H and supporting redlines
12

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 60 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

2253

Wong Deposition, 10/18/2016 - Exhibit 549 - 5/27/2004 E-mail from Natalie Wong to Doug Uelmen Re. "Recovery
Stats"

2254

Wong Deposition, 10/18/2016 - Exhibit 552 - 2/17/2006 Memo from Mickey Graves and Natalie Wong Re.
"Recovery Filter (Generation 1) Product Assessment Team Minutes - Fractures"

3262

REDACTED

Complaint File - 03/09/2010, 263280, G2 - RF310F, 2907 Detachment of device or device component

3270

REDACTED

Complaint File - 03/30/2010, 266286, G2 - RF310F, 2907 Detachment of device or device component

3304

REDACTED

Complaint File - 07/28/2010, 282326, Eclipse - EC500J, 2907 Detachment of device or device component; 2907M
Filter Limb(s)

3572

Securities and Exchange Commission Form 10-K for C.R. Bard, Inc. for the fiscal year ended December 31st, 2016

3573

Securities and Exchange Commission Form 10-Q for C.R. Bard, Inc. for the quarterly period ended September 30th,
2017

4327

REDACTED

2/10/06 monthly meeting - redesign due to caudal migration (excludes last 4 pages)

4328

Ganser Exh. 517 Device Labeling Guidance, General Program Memorandum

4330

Asch Deposition, 05/02/2016 - Exhibit 206, July 21, 1999 letter to Dr. Freeland from Dr. Asch

4332

Updated CV of Murray Asch

4392

Truthfulness and Accuracy Statement Vierling Deposition, Exhibit 227

4409

G2 Brochure 2

4412

Email from: Gin Schulz to Kevin Shiffrin regarding Recovery Filter Limb Fractures with attachment of RF Limb
detach

4414

Email from Brian Reinkensmeyer to Baird cc Pellicio and Randall re "Filter study Idea"

4415

Email from Mike Randall to Carr and Raji-Kubba re "Misclassified??"

4416

Bill Little email re Eclipse Filter Naming

4420

REDACTED

Meridian Vena Cava Filter and Jugular Delivery System Product Performance Specification PPS, Revision 3
13

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 61 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

4428

Eclipse Vena Cava Filter Ad

4430

Eclipse Vena Cava Filter Brochure

4433

Eclipse Vena Cava Filter Patient Questions & Answers

4438

G2 Express Vena Cava Filter Brochure

4454

Eclipse Vena Cava Filter Concept POA, Revision 2

4455

Vail Vena Cava Filter DIS

4456

Eclipse Vena Cava Filter Product Performance Specification (PPS)

4457

Vail Filter System DFMEA

4459

Eclipse Vena Cava Filter Jugular Vein Approach IFU

4467

8/12/2011 email from Mike Randall to Joni Creal re Corp approval needed for Cleveland Clinic Studies w/ attached
PowerPoint slides re Filter Fixation and Migration: Forces and Design

4468

6/10/2011 email from Mike Randall re Meridian Presentation for SSM 2011

4469

Data Source Evaluation memo from Natalie Wong to Quality Systems Coordinator, October 2010

4486

G2 Express Project Plan FM0700150 Rev 6 1-30-07

4499

Meridian Vena Cava Filter vs. Eclipse Vena Cava Filter

4504

REDACTED

Monthly Management Report, dated 4/8/09

4507

REDACTED

Monthly Management Report, dated 7/9/09

4509

REDACTED

Monthly Management Report, dated 10/8/09

4512

REDACTED

Monthly Management Report, dated 1/1/10

4514

REDACTED

Monthly Management Report, dated 3/8/10

4515

Only admitted
pgs. 12 & 13

Monthly Management Report, dated 4/8/10

14

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 62 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

4519

REDACTED

Monthly Management Report, dated 8/9/10

4522

REDACTED

Monthly Management Report, dated 11/8/10

4528

REDACTED

Monthly Management Report, dated 5/9/11

4532

REDACTED

Monthly Management Report, dated 9/9/11

4533

REDACTED

Monthly Management Report, dated 10/10/11

4534

REDACTED

Monthly Management Report, dated 11/8/11

4552

Decant Deposition Exhibit 273, Failure Investigation Report, Recovery Filter Migration FIR-04-12-02, Rev. 00

4554

NMT Medical, BSC Presentation, 5/22/2000

4565

FRE 1006 Chart - Plaintiff's Compilation Complaint Record Detail

4595

Kandarpa Deposition, 07/19/2018 - Exhibit 05 - Medical Monitor Meeting Minutes, August 29, 2005, Beechwood
Hotel, Worcester, MA, Version 1.0 (6 pages), signed 12/16/05. *only the last page is bates stamped BBA-00012962

4596

Kandarpa Deposition, 07/19/2018 - Exhibit 06 - Everest Clinical Trial, Medical Monitor Meeting agenda and power
point, June 19, 2006, Revision B

4599

Kandarpa Deposition, 07/19/2018 - Exhibit 09 - Summary of Filter Movement, 5mm or greater, Final Clinical
Summary Report EVEREST

4600

Kandarpa Deposition, 07/19/2018 - Exhibit 10 - Device Observation Table (as of 10/23/2006)

4601

Kandarpa Deposition, 07/19/2018 - Exhibit 11 - Listing of Device Observations, Final Clinical Summary Report
EVEREST

4602

Kandarpa Deposition, 07/19/2018 - Exhibit 12 - Adjudication Manual of Operations, EVEREST (trial exhibit 5983

4603

Kandarpa Deposition, 07/19/2018 - Exhibit 13 - Recovery G2 Filter System - Femoral and Jugular/Subclavian
Delivery Kits, Tradition 510(k), October 31, 2007

4604

Kandarpa Deposition, 07/19/2018 - Exhibit 14 - Article entitled "Technical Success and Safety of Retrieval of the G2
Filter in a Prospective, Multicenter Study", Nov. 2009

15

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 63 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

4607

Kandarpa Deposition, 07/19/2018 - Exhibit 17 - Memorandum dated June 21, 2006 Subject: G2 Caudal Migration
Failure Investigation Team Agenda, From Natalie Wong

4617

VanVleet Deposition, 09/26/2016 - Exhibit 496 - Bard Recovery G2 EVEREST Final Study Report

4785

Fermanich Deposition, 3/17/17 - Exhibit 2: Email, from Tim Hug, 3/19/10, Re: Adversity-How are you going to
respond (6 pages)

4786

Fermanich Deposition, 3/17/17 - Exhibit 3: Email, from Tim Hug, 4/27/10, Re: Flair-April Expected Results (3
pages)

4794

Fermanich Deposition, 3/17/17 - Exhibit 11: Email from Tim Hug to Hans Yentz (and others), 2/9/10, Subject: Filter
Accounts-Eclipse Transition (2 pages)

4795

Fermanich Deposition, 3/17/17 - Exhibit 12: G2 Filter product brochure (4 pages)

4797

Fermanich Deposition, 3/17/17 - Exhibit 14: Email from Tim Hug to Nine Aghakhan (and others), 3/24/10, Subject:
FW: G2 X not available for order (2 pages)

4798

Fermanich Deposition, 3/17/17 - Exhibit 15: Email from Bret Baird to TPW-PV Sales-DG, 4/28/10, Subject: When
was the last time… (2 pages)

4800

Fermanich Deposition, 3/17/17 - Exhibit 17: Email from David Ciavarella to Brian Berry (and others), 12/27/05,
Subject: FW: G2 Caudal Migrations (2 pages)

4804

Only admitted
1st email,
redacted other
emails

Fermanich Deposition, 3/17/17 - Exhibit 21: Email from Mary Christine Starr to Matt Fermanich, 2/17/11, Subject:
RE: Technician Registration (4 pages)

4806

Only admitted
pg. 2

Fermanich Deposition, 3/17/17 - Exhibit 23: Email from Cynthia L. Haas to Matt Fermanich, 4/21/11, Subject: RE:
Expired product (7 pages)

4809

Fermanich Deposition, 3/17/17 - Exhibit 26: Email from Tim Hug to Matt Fermanich, 12/13/00, Subject: G2 Filter
Discontinued (2 pages)

16

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 64 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

4812

Fermanich Deposition, 3/17/17 - Exhibit 29: BPV Memo from Filter Marketing to Bill Little, 4/27/10, Subject: Filter
naming (2 pages)

4820

Fermanich Deposition, 3/17/17 - Exhibit 37: Health Hazard Evaluation memo from David Ciavarella to Gin Schulz,
2/15/06, Re: G2 Inferior Vena Cava Filter - Migration (3 pages)

4842

Hug Deposition, 8/23/17 - Exhibit 1117: Email to Nine Aghakhan from Tim Hug, 3/8/11, Subject: FW: GW Fem
Filter Backorder (2 pages)

4893

GX2 Risk Analysis

4894

Eclipse Risk Analysis

4895

Meridian Risk Analysis

4896

Caudal Migration Testing Meridian and Optease

4897

G2 Express Product Performance Specification, PPS-8058

4938

BPV Consulting Request Form

5001

Dec. 2004 Dear Doctor Letter

5003

Feb. 8, 2005 Conference FDA and BPV re Recovery Retrievable (K031328)

5017

Aug. 5, 1999 R&D Technical Report RNF Migration Study, Design Verification (RD-RPT-100)

5022

RD-LNB-087 Laboratory Notebook

5037

ETR-05-02-02 (Effects of Changes to the Recovery Filter & The Femoral Delivery System on Filter Stresses Based
on FEA Analysis)

5126

Guidance for Industry and FDA Reviewers/Staff - Guidance for Cardiovascular Intravascular Filter 510(k)
Submissions

5126

Guidance for Industry and FDA Reviewers/Staff - Guidance for Cardiovascular Intravascular Filter 510(k)
Submissions

5164

July 8, 2003 Fax IMPRA to FDA re Recovery Retrievable (K031328)

17

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 65 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.
5169

Notes
REDACTED

Description
Apr. 25, 2003 Recovery Retrievable Abbreviated 510(k) (K031328)

5177

Nov. 27, 2002 FDA Clearance Letter re Recovery Permanent (K022236) (Substantial Equivalence)

5178

Oct. 25, 2002 Letter IMPRA to FDA re Recovery (K022236)

5179

Oct. 4, 2002 Letter FDA to IMPRA re Recovery (K022236)

5182

Aug. 30, 2002 Letter IMPRA to FDA re Recovery (K022236)

5187

Aug. 5, 2002 Letter FDA to IMPRA re Recovery (K022236)

5189

July 10, 2002 IMPRA Recovery Permanent Special 510(k) (K022236)

5193

Feb. 28, 2005 Letter BPV to FDA re FDA AI re Recovery Retrievable (K031328)

5195

Nov. 30, 2004 Letter FDA to BPV re Recovery IFU and DDL, dear doctor letter

5196

Oct. 5, 2004 Letter BPV to FDA re Recovery IFU and DDL

5197

July 25, 2003 FDA Clearance Letter re Recovery Retrievable (K031328) (Substantial Equivalence)

5232

RD-RPT-116 (RNF Migration Study) (Test report for RD-SOP-035.02) RD-RPT-116

5233

RD-SOP-054.00 (Recovery Filter Endura TEC Fatigue Testing SOP NMT)

5234

RD-RPT-099 (Recovery Filter Endura TEC Fatigue Testing Report NMT)

5238

Slides from Bariatric Surgeons Panel Meeting on Feb. 12, 2005

5239

Jan. 21, 2005 Conference FDA and BPV re DDL and Recovery Retrievable (K031328)

5247

May 11, 2005 BPV began distributing DCL

5252

ETR-04-03-02 (RNF v. Competitive Product -- migration resistance)

5268

NMT's 510(k) (K963016) for modifications to the SNF(submitted by Hogan & Hartson)

5272

Nov. 23, 2009 BPV's Eclipse Filter System Special 510(k) (K093659)

5273

Jan. 14, 2010 FDA Clearance Letter Eclipse Filter (K093659) (Substantial Equivalence)

18

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 66 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

5283

G2 IFU (Femoral) PK5250500 Rev. 0 01/08

5290

TD-00456 (EVEREST Study Final Report)

5296

G2 Filter Product Performance Specification, v.2

5301

ETR-05-01-06 Animal Model Evaluation of Recovery Filter G1A Femoral System Report

5302

TPR 05-01-13 G1A Recovery Filter Femoral System Design Verification and Validation Protocol

5303

ETR-05-02-05 (G2® DV&V summary testing)

5304

ETR 05-02-11 G1A Recovery Filter Femoral System Chronic Animal Study Report

5315

Phase 2 Design Review G1A Recovery Filter Femoral Delivery System, BPV-17-01-00121226 -255

5316

Phase 3 Design Review (Design Review 3 & 4) G1A Recovery Filter Femoral Delivery System, BPV-17-0100121256 -286

5322

Nov. 2, 2005 FDA Grants Full Approval of G2 Everest Study (G051304)

5323

Aug. 8, 2005 FDA Grants BPV Conditional Approval for G2 Everest Study (G050134)

5324

July 8, 2005 BPV's original IDE submission re G2 Everest Study (G050134)

5325

REDACTED

Oct. 3, 2005 Letter BPV to FDA re G2 Everest Study (G051034) and Conditional Approval

5329

REDACTED

June 21, 2006 Letter BPV to FDA re G2 Everest Study (G051304) IDE Supplement

5333

Feb. 2, 2007 Letter BPV to FDA re G2 Everest Study (G051304) Annual Progress Report

5334

Sept. 21, 2007 Letter FDA to BPV Questions re G2 Everest Study (G051304)

5335

Aug. 23, 2007 Letter BPV to FDA re G2 Everest Study (G051304) Annual Progress Report

5336

Oct. 25, 2007 Letter BPV to FDA re Responses to FDA re G2 Everest Study (G051304), BPV-17-01-00123498 -562

5339

Jan. 15, 2008 FDA Clearance Letter G2 Filter Retrievable (K073090) (Substantial Equivalence)

5340

Oct. 31, 2007 BPV's G2 Filter Retrievable Traditional 510(k) (K073090)

5343

Aug. 29, 2005 FDA Clearance Letter re G2 Permanent (K050558) (Substantial Equivalence)
19

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 67 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

5344

July 28, 2005 Letter FDA to BPV re AI re Modified Recovery (K050558)

5348

Mar. 30, 2005 Letter FDA to BPV re Modified Recovery (K050558)

5349

Mar. 2, 2005 BPV's Modified Recovery Filter Special 510(k) (K050558)

5350

REDACTED

June 3, 2005 Letter BPV to FDA re Modified Recovery conversion Traditional 510(k) (K050558)

5352

Aug. 10, 2005 Letter BPV to FDA Responses to AI re G2 (K050558)

5353

Nov. 25, 2005 FDA Clearance Letter G2 Filter - Jugular (K052578) (Substantial Equivalence)

5354

Sept. 19, 2005 BPV's G2 Filter - Jugular Subclavian Delivery Kit Special 510(k) (K052578)

5361

Sept. 25, 2006 BPV's G2 Filter - Femoral Delivery Kit Special 510(k) (K062887)

5362

Oct. 26, 2006 FDA Clearance Letter G2 Filter - Femoral Delivery Kit (K062887)

5368

July 30, 2008 FDA Clearance Letter G2 Express Filter (K080668) (Substantial Equivalence)

5373

Mar. 7, 2008 BPV's G2 Express Filter Special 510(k) (K080668)

5376

Oct. 31, 2008 FDA Clearance Letter G2X Filter (K082305) Substantial Equivalence

5379

Aug. 12, 2008 BPV's G2X Filter Special 510(k) (K082305)

5384

G2 Express Feasibility Acute Animal Study Report TR-07-05-18

5385

G2 Express Filter Arm Fatigue Comparison TR-07-07-04

5483

sopq1417500 Rev 1 -- Statistical Complaint Trending Procedure PMA Related, BPV-17-01-00144123 - 126

5486

Dec. 17, 2009 Letter from BPV to FDA re Eclipse Filter System Response to FDA Questions (K093659)

5488

June 21, 2010 Letter from BPV to FDA re Eclipse Filter System Response to FDA Questions (K101431)

5523

ETR-04-03-05 (RNF Characterization testing comparing GFO v. NMT manufactured filters) (followed TPR-04-0202) ETR-04-03-05, Rev. 0 (GFO and NMT Manufactured Recovery; Filters Migration Resistance Comparison, Phase
1)

20

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 68 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

5526

TPR-04-02-02 (Protocol for RNF Migration Testing v. Competitive) Test Protocol Number TPR-04-02-02 (Rev. 0) -Characterization of the Recovery Filter (RF) - Migration Resistance

5534

Picture of Clot from Feb. 2004 RNF Migration

5536

Meeting Summary from Filter Expert Panel June 1, 2006

5537

June 2006 Expert Panel Meeting Slides

5539

Only admitted
pgs. 12 -32

G2 Caudal Migration Failure Investigation Report Aug. 4, 2005 G2 Filter Caudal Migration Failure Investigation
Report (FIR-06-01-01) G2 Caudal Migration Failure Investigation Report

5560

Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 Rev 11, BPV-17-01-00166749 776.

5561

Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 Rev 12, BPV-17-01-00166777 806

5563

Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 REv 14

5565

Standard Operating Procedures / Division Operating Procedures -- RA-STD-002 Rev 10

5586

May 20, 2010 BPV's Eclipse Filter Special 510(k) (K101431)

5587

June 18, 2010 Letter FDA to BPV re FDA AI Demand re Eclipse (K101431)

5588

Dec. 15, 2009 Letter FDA to BPV re FDA Al Demand re Eclipse (K093659)

5589

June 22, 2010 - FDA Clearance Letter for Eclipse Filter (K101431) (Substantial Equivalence)

5593

Aug. 14, 2009 Conference FDA and BPV re future Eclipse Filter 510(k)

5602

REDACTED

FDA CONTACT REPORT January 7 2010 FINAL

5612

REDACTED

Nov. 17, 2009 (Filters and future submissions)

5691

Only admitted
pgs. 12-32

BPV FDA 483 Update Response March 26, 2015, BPV-17-01-00200156 - 338

21

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 69 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.
5706

Notes
Only admitted
pgs. 48-61

Description
September 3 2015 Update Response to Warning Letter issued July 13 2015.pdf

5851

TD-04698 Retrospective IVC Filter Review.pdf

5872

FDA Warning Close Out Letter

5874

Bard filter rate information December 2016

5877

1996 Memo from Veronica Price

5879

April 11, 2006 Letter to FDA re Caudal Migration

5880

March 23, 2006 Letter to FDA re G2 Caudal Migration

5881

May 11, 2006 Letter to FDA re Caudal Migration

5905

Jan. 22, 2005 Email to FDA

5923

REDACTED

September 2010 Letter to Clinicians re FDA PHN

5929

TR-07-12-01 (Test Report re G2 Express DV& V Flat Plate Fatigue and Corrosion)

5931

G2X (Jugular) 2009.10 – PK5100070 rev. 5 IFU

5942

January 7, 2010 FDA PowerPoint Presentation

5946

QMBR—July 2006

5949

ETR-06-05-02 (Test report re G2® Clot Trapping Efficiency)

5967

G2 Risk Benefit Analysis (RBA-0003, Rev. 0)

5970

HHE re G2 Caudal Migration February 15, 2006

5991

FM1287100 Rev. 5 (MDR Reportability Guidelines)

5994

TD-04316 Nov. 4, 2015 FDA and Bard Teleconference

5995

TD-04326 Oct. 26, 2015 FDA and Bard Teleconference

6013

Dec. 27, 2010 Letter from BPV to FDA re Meridian
22

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 70 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

6046

August 28, 2006 EVEREST Medical Monitor Adjudication Meeting Minutes

6061

Aug. 22, 2005 Internal FDA memo reviewing BPV's Responses to FDA Al re G2 (K050558)

6064

July 26, 2005 Internal FDA memo re BPV Responses to FDA AI re Modified Recovery (K050558)

6075

Nov. 10, 2004 FDA Internal Memo re Dear Doctor Letter

6082

FDA_PRODUCTION_00001288 -- July 2, 2003 Email chain FDA and BPV re Recovery Retrievable (K031328)

6089

Product Development Cycle PPT

6842

ACR-SIR-SPR Practice Parameter for the Performance of Inferior Vena Cava (IVC) Filter Placement for the
Prevention of Pulmonary Embolism. Revised 2016.
***

Note: “Admitted for the limited purpose to establish knowledge to the medical community, not for the truth of the
matter asserted.”

6892

Binkert CA, Drooz AT, Caridi JG, Sands MJ, Bjarnason H, Lynch FC, Rilling WS, Zambuto DA, Stavropoulos SW,
Venbrux AC, Kaufman JA. Technical success and safety of retrieval of the G2 filter in a prospective, multicenter
study. J Vasc Interv Radiol. 2009 Nov;20(11):1449-53. doi: 10.1016/j.jvir.2009.08.007.

6991

FDA Safety - Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use,
08/09/2010.

6992

FDA Safety Communications, Removing Retrievable Inferior Vena Cava Filters. 05/06/2014.
http://wayback.archiveit.org/7993/20170722215731/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm

6993

FDA Safety Communications, Removing Retrievable Inferior Vena Cava Filters: Initial Communication. 08/09/2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm

7312

SIR Guidelines for IVC Filters
***

Note: “Admitted for the limited purpose to establish knowledge to the medical community, not for the truth of the
matter asserted.”

23

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 71 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

7411

2008 Surgeon General's Call to Action re PE and DVT

7753

2014 Draft FDA Guidance re Benefit-Risk Factors When Determining Substantial Equivalence in Premarket
Notifications 510k with Different Technological Characteristics

7758

2014 FDA Guidance re 510k Evaluating Substantial Equivalence in Premarket Notifications

7771

Braun Vena Tech LP Femoral – October 2010

7787

Cordis Optease Femoral Jugular Antecubital - 2013

7795

Screenshot from FDA, MAUDE - Manufacturer and User Facility Device Experience, available online at
https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfmaude/search.cfm

7960

IVC Filters Clinical Overview

7961

Corporate Quality Assurance Manual, Standard for Product Complaint Handling

7962

Corporate Quality Assurance Manual, Standard for Medical Device Reporting

7900

Demonstrative depiction of sales of bard’s retrievable IVC filters

8325

Eclipse IFU 02.2010 PK5100600 Rev. 1

8358

TR-09-10-15 -- Eclipse Flat Plate Fatigue and Corrosion Examination of the Vail (Eclipse) Filter

8359

TR-09-10-16 DV&V Eclipse Filter Arm Fatigue Comparison Study (Project #8113)

8362

Eclipse Filter Patient Questions & Answers

8368

TP-09-10-15 Rev. 0 - Eclipse DV&V Flat Plate Fatigue and Corrosion Test Protocol

8482

Bard IVC Filter G3 Design/Development Timeline

8546

Draft Test Report re Rotary Beam Fatigue of Nitinol Wire

8572

G3 Meeting Minutes Nov 27, 2007

8574

TR 09-10-10, Test Report Cyclic Fatigue Testing of Electropolished Vail Filter Wire

8575

TP 09-10-10, Test Protocol Cyclic Fatigue Testing of Electropolished Vail Filter Wire
24

Case 2:15-md-02641-DGC Document 21589 Filed 09/10/20 Page 72 of 72
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (FOURTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial
Ex. No.

Notes

Description

8583

G3 Project Status Report April 19, 2006

8837

Defendants' Exhibit 10 to Joint Report on Determining Filter Type

9080

10/7/07 Email from Dr. Lehman

Document deemed no longer subject to the Protective Order
Trial Ex.
No.
908

Notes

Description
Ciavarella Deposition, 03/01/2011 - Exhibit 12 - 5/11/2005 "Dear Colleague" letter from BPV re. the Recovery filter
system

25