Whitmore v. C R Bard Incorporated et al
Filing
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AMENDED FINAL SUGGESTION OF REMAND AND TRANSFER ORDER. ORDERED Schedule C - Arizona Case to be Unconsolidated from the MDL. See Order for Full Details. Signed by Senior Judge David G Campbell on 4/26/21. (MAP)
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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,
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No. MDL 15-02641-PHX-DGC
AMENDED FINAL SUGGESTION OF
REMAND AND TRANSFER ORDER
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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”).
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inferior vena cava (“IVC”) filters. The MDL Plaintiffs received implants of Bard IVC
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filters and claim they are defective and caused Plaintiffs to suffer serious injury or death.
Bard manufactures and markets medical devices, including
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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.
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Thousands of cases pending in the MDL have settled. See Docs. 16343, 19445,
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19798, 21167, 21410.
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proceedings. Since August 2019, the Court has suggested the remand of nearly 100 cases
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that were transferred to this MDL by the United States Judicial Panel for Multidistrict
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Litigation (the “Panel”), and has transferred to appropriate districts more than 2,500 cases
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that were directly filed in the MDL. See Docs. 19899, 20672, 21462, 21589, 21820.
The remaining cases no longer benefit from centralized
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The parties filed updated status reports identifying approximately 400 cases that
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have not settled and are ripe for remand or transfer, including 19 cases that were
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voluntarily dismissed under a settlement agreement but where the Plaintiffs have opted
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out of the settlement. Docs. 21995, 22012. The Court has vacated the dismissal orders in
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the cases where the Plaintiffs have opted out of the settlement, and those cases have been
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reinstated in the MDL. Doc. 22034 and amended at Doc. 22035.
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The cases listed on Schedule A should be remanded to the transferor courts
pursuant to 28 U.S.C. § 1407(a). See Doc. 21995-1. The Court therefore provides this
Suggestion of Remand to the Panel. The cases listed on Schedule B, which were directly
filed in this MDL, will be transferred to appropriate districts pursuant to 28 U.S.C.
§ 1404(a). See Docs. 21995-2, 22012-2. To assist the courts that receive these cases, this
order will describe events that have taken place in the MDL. A copy of this order, along
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with the case files and materials, will be available to courts after remand or transfer. The
case listed on Schedule C will be unconsolidated from the MDL, will remain in the
District of Arizona, and will be assigned to the undersigned judge. See Doc. 21995-2 at 3
(Whitmore v. C. R. Bard, Inc., No. CV-17-01353).
This MDL has now concluded, as all remaining MDL cases have settled, have
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been dismissed with prejudice, or will be remanded or transferred to their home courts for
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further litigation consistent with the MDL.
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I.
Suggestion of Remand.
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A.
Remand Standard.
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The power to remand MDL cases rests solely with the Panel. 28 U.S.C. § 1407(a);
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see Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 28 (1998).
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The Panel typically relies on the transferee court to suggest when remand is appropriate.
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See J.P.M.L. Rule 10.1(b)(i); In re Motor Fuel Temperature Sales Practices Litig.,
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No. 07-MD-1840-KHV, 2012 WL 1963350, at *1 (D. Kan. May 30, 2012). Indeed, the
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Panel “is reluctant to order a remand absent the suggestion of the transferee judge[.]”
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J.P.M.L. Rule 10.3(a); see In re Regions Morgan Keegan Sec., Derivative & ERISA
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Litig., No. 2:09-md-2009-SHM, 2013 WL 5614285, at *2 (W.D. Tenn. Feb. 28, 2013).
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The transferee court may suggest remand when a case is “ready for trial, or . . . would no
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longer benefit from inclusion in the coordinated or consolidated pretrial proceedings.”
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In re Multi-Piece Rim Prods. Liab. Litig., 464 F. Supp. 969, 975 (J.P.M.L. 1979); see
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In re TMJ Implants Prods. Liab. Litig., 872 F. Supp. 1019, 1038 (D. Minn. 1995).
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B.
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The primary purposes of this MDL – coordinated pretrial discovery and resolution
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of common issues – have been fulfilled. All common fact and expert discovery has been
The Panel Should Remand the Cases Listed on Schedule A.
The Court has also resolved many Daubert motions and Defendants’
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completed.
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summary judgment motion based on preemption, as well as other summary judgment and
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in limine motions in the bellwether cases. Six bellwether jury trials were scheduled, three
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were held, a fourth settled on the eve of trial, one was resolved by summary judgment,
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and one was dropped when Plaintiffs decided it would not provide helpful information.
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The pending MDL cases listed on Schedule A have not settled and no longer
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benefit from centralized proceedings. See Doc. 21995 at 2. The remaining case-specific
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issues are best left to the transferor courts to resolve. The Court therefore suggests that
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the Panel remand the cases on Schedule A to the transferor courts for further proceedings.
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See Doc. 21995-1; see also In re TMJ Implants, 872 F. Supp. at 1038 (suggesting remand
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of cases that no longer benefited from consolidated pretrial proceedings).
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II.
Transfer Under 28 U.S.C. § 1404(a).
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A.
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Section 1404(a) provides that “[f]or the convenience of parties and witnesses, in
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the 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
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parties have consented.”
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Transfer Standard.
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B.
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Not all MDL cases were transferred to the Court by the Panel. Pursuant to Case
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Management Order No. 4 (“CMO 4”), many cases were filed directly in the MDL
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through use of a short form complaint. Doc. 363 at 3 (amended by Docs. 1108, 1485).
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Plaintiffs were required to identify in the short form complaint the district where venue
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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.
The Direct-Filed Cases Listed on Schedule B Will Be Transferred.
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Pursuant to § 1404(a), the Court will transfer the cases listed on Schedule B to
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the districts identified in the short form complaints. See Docs. 21995 at 2, 21995-2; see
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also In re Biomet M2a Magnum Hip Implant Prods. Liab. Litig., No. 3:12-MD-2391,
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2018 WL 7683307, at *1 (N.D. Ind. Sept. 6, 2018) (transferring cases under § 1404(a)
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where they would “no longer benefit from centralized proceedings[] and the remaining
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case-specific issues are best left to decision by the courts that will try the cases”).
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Defendants’ right to challenge venue and personal jurisdiction upon transfer is preserved.
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See Docs. 19899 at 4-6, 20672 at 4, 21426 at 4.
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III.
The MDL Proceedings.
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A summary of the MDL proceedings is provided below to assist courts on remand,
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if ordered by the Panel, and courts receiving transfers under § 1404(a). CMOs, discovery
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orders, and other significant rulings are listed in Exhibit 1. See Doc. 21727-1. Exhibits
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admitted at the bellwether trials are listed in Exhibit 2. See Doc. 21727-2. The status of
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the remaining case-specific discovery and other pretrial issues in individual cases should
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be addressed by the courts receiving the cases on remand or transfer.
Plaintiffs’ Claims and the Pleadings.
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A.
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The IVC is a large vein that returns blood to the heart from the lower body. An
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IVC filter is a small device implanted in the IVC to catch blood clots before they reach
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the heart and lungs. This MDL involves multiple versions of Bard’s retrievable IVC
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filters – the Recovery, G2, G2X, Eclipse, Meridian, and Denali.
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These filters are
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umbrella-shaped devices that have multiple limbs fanning out from a cone-shaped head.
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The limbs consist of legs with hooks that attach to the IVC wall and curved arms to catch
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or break up blood 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.
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that Bard filters are safe and effective, that their complication rates are low and
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comparable to those of other IVC filters, and that the medical community is aware of the
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Defendants dispute these allegations, contending
risks associated 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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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
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and XII); negligence per se (Count IX); breach of warranty (Counts X and XI);
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concealment (Count XIII); consumer fraud and deceptive trade practices (Count XIV);
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loss of consortium (Count XV); and wrongful death and survival (Counts XVI and XVII).
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Doc. 364 at 34-63. 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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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 IVC 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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Docs. 249, 363, 365. Plaintiffs also provided Defendants with profile forms and fact
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sheets that describe their individual claims and conditions. See Doc. 365.
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B.
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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 49 CMOs.
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These orders are discussed below and can be found on this District’s website at http://
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www.azd.uscourts.gov/case-info/bard.
Case Management Orders.
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C.
Lead Counsel.
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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
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the responsibilities of Lead Counsel. Doc. 248. Plaintiffs’ Lead Counsel has changed
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since the inception of the MDL. Mr. Ramon Lopez, of Lopez McHugh, LLP, in Newport
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Beach, California, and Mr. Mark O’Connor, of Beus Gilbert PLLC, in Phoenix, Arizona,
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are now Lead Counsel for Plaintiffs. Doc. 5285. Mr. Richard North of Nelson Mullins
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Riley & Scarborough, LLP, in Atlanta, Georgia, is Defendants’ Lead Counsel.
Plaintiffs’ Steering Committee and Common Benefits Fund.
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D.
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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”).
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The PLC assists all Plaintiffs in the MDL by overseeing discovery, appearing in court,
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attending status conferences, and preparing motions and responses regarding case-wide
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discovery matters.
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Executive Committee (“PEC”) to assist Lead Counsel in the administration, organization,
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and strategic decisions of the PLC. Doc. 4016. The configuration of the PSC has
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changed during the course of the litigation. See Docs. 248, 4016, 5285.
CMO 1 has been amended to select and appoint a Plaintiffs’
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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
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all 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
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for costs. Doc. 18038.
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Upon remand or transfer, individual Plaintiffs likely will be represented by their
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own counsel – the attorney or attorneys who filed their original complaint. Plaintiffs’
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Lead Counsel, the PSC, the PLC, and the PEC were tasked with managing the MDL for
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Plaintiffs, not the individual cases on remand or transfer.
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E.
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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
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proposed protective order (including Rule 502 provisions), a proposed protocol
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governing the production of electronically stored information (“ESI”), as well as
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deadlines to complete first-phase MDL discovery and address privilege log issues.
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Doc. 249. Thereafter, the Court held periodic status conferences to ensure that the parties
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were on task and to address routine discovery issues and disputes. In addition to the
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status conferences, the Court conducted telephone hearings to address time-sensitive
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issues, as well as numerous additional conferences to consider various matters such as
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general case management issues, dispositive motions, the bellwether trial process, and the
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settlement process.
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F.
Status Conferences.
Discovery.
1.
General Fact Discovery.
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Prior to the establishment of this MDL, Plaintiffs’ counsel had conducted
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substantial discovery against Bard concerning all aspects of Bard IVC filters, including
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the design, testing, manufacturing, marketing, labeling, and post-market surveillance of
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the devices. Bard produced numerous documents and ESI and responded to thousands of
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written discovery requests, and more than 80 corporate witness depositions were taken.
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The 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
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previously deposed, as well as numerous depositions of other Bard corporate witnesses,
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including several Rule 30(b)(6) depositions. Docs. 3685, 4311. CMO 9 governed the
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production of 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
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production of complaint and adverse event files, and an updated version of Bard’s
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complaint database relating to IVC filters. Doc. 249. Plaintiffs also conducted a Rule
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30(b)(6) deposition concerning the FDA inspection and warning letter, and a deposition
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of corporate witness Kay Fuller.
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The parties completed the second phase of fact discovery in February 2017.
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CMO 8 set deadlines for the second phase, which included all common fact and
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expert issues in the MDL, but not case-specific issues to be resolved after remand or
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transfer.
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discovery related to Bard’s system architecture for ESI, Bard’s ESI collection efforts, ESI
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relating to Bard’s IVC filters, and Bard’s national and regional sales and marketing
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practices.
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Fuller’s allegations that a submission to the FDA regarding the Recovery filter did not
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bear her original signature.
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corporate witnesses concerning the FDA inspections and warning letter. Id.
Docs. 249, 519.
Second-phase discovery included extensive additional
Plaintiffs also deposed two corporate witnesses in connection with Kay
Doc. 1319 (CMO 10).
Plaintiffs deposed additional
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Bard also produced discovery regarding the sales and marketing materials related
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to the SNF, documents comparing filter performance and failure rates to the SNF, and
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internal and regulatory communications relating to the SNF. Docs. 1319, 10489. The
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Court denied Plaintiffs’ request to obtain ESI discovery from Bard’s overseas operations.
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Doc. 3398. The Court also denied Defendants’ request to discover communications
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between Plaintiffs’ counsel and NBC news related to stories about the products at issue in
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this litigation, and third-party financing that may be in place with respect to MDL
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Plaintiffs.
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between Plaintiffs and the FDA related to the FDA warning letter, but the Court denied
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Defendants’ request to depose Plaintiffs’ counsel regarding these communications.
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Docs. 3312, 4339. Defendants also produced punitive damages discovery, and Plaintiffs
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conducted a Rule 30(b)(6) deposition related to Bard’s net worth.
Docs. 3313, 3314.
Plaintiffs were required to produce communications
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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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remanded and transferred cases. See Docs. 16343, 19959, 21063. Thus, courts receiving
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these cases need not be concerned with facilitating general fact discovery on remand or
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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
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exchange abbreviated profile forms. Doc. 365 (as amended by Doc. 927). Plaintiffs were
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required to provide Defendants with a Plaintiff profile form (“PPF”) that described
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individual conditions and claims. Id. at 5-9. Upon receipt of a substantially complete
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PPF, Defendants were required to provide the individual Plaintiff with a Defendants’
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profile form (“DPF”) that disclosed information and documents concerning Defendants’
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contacts and relationship with Plaintiff’s physicians, tracking and reporting of Plaintiff’s
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claims, and certain manufacturing related information for Plaintiff’s filter. Id. at 12-14.
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Completed profile forms were considered interrogatory answers under Rule 33 or
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responses to requests for production under Rule 34, and were governed by the standards
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applicable to written discovery under Rules 26 through 37. Id. at 2-3. CMO 5 also set
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deadlines and procedures for resolving any purported deficiencies with the parties’
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profile forms, and for dismissal of cases that did not provide substantially completed
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profile forms. Id. at 2. The Court has dismissed certain cases where Plaintiffs failed to
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provide complete PPFs. See Docs. 19874, 20667, 21461, 21579.
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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”).
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Docs. 1662, 3214, 4311 (CMOs 11, 15, 19). Plaintiffs in Group 1 were required to
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provide Defendants with a Plaintiff fact sheet (“PFS”) that described their individual
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conditions and claims in greater detail, and provided detailed disclosures concerning their
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individual background, medical history, insurance, fact witnesses, prior claims, and
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relevant documents and records authorizations. Docs. 1153-1, 1662 at 3.
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Upon receipt of a PFS, Defendants were required to provide the individual
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Plaintiff 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,
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sales and marketing information for the implanting facility, manufacturing information
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for Plaintiff’s filter, and other relevant documents. Docs. 1153-2, 1662 at 3. Completed
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fact sheets 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. 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.
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at 2, 4-5. CMO 12 governed records discovery for Group 1. Doc. 1663. The parties
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agreed to use The Marker Group to collect medical, insurance, Medicare, Medicaid,
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prescription, Social Security, workers’ compensation, and employment records for
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individual plaintiffs from third-parties designated as custodians for such records in the
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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
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trials and further case-specific discovery (“Bellwether Group 1”). Docs. 1662, 3685,
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4311, 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 Schedules A and B during the MDL proceedings, other
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than exchanging abbreviated profile forms. The Court concluded that any additional
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case-specific discovery in these cases should await their remand or transfer. Thus, courts
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receiving these 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
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Schedules A and B during the MDL proceedings. The Court concluded that case-specific
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expert discovery in these cases should await their remand or transfer. Thus, courts
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receiving these cases should set a schedule for the completion of case-specific expert
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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
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the 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
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inspection and, in some cases, withdrew certain claims of attorney-client privilege and
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produced the previously withheld items.
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CMO 3 governed the non-waiver of any privilege or work-product protection in
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this 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.
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Doc. 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
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the motion in part. Doc. 2813. The parties identified several categories of disputed
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documents and provided sample documents for in camera review. The Court denied
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Plaintiffs’ motion with respect to seven of eight categories of documents and found only
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one of the sample documents in one of the categories to contain unprivileged portions
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that should be produced. The Court found all other documents protected by the attorney-
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client privilege or work product doctrine. The Court directed the parties to use this ruling
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as a guide to 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
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adverse event reports, complaint files, and related documents in accordance with the
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Health Insurance Portability Act of 1996 (“HIPAA”) and under 21 C.F.R. § 20.63(f).
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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.
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November 2016. Doc. 4015.
CMO 17 was amended in
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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.
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Doc. 13126. This motion was denied. Doc. 14446. A list of exhibits admitted at the
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bellwether trials (excluding case-specific medical records) and documents deemed no
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longer subject to the protective order are attached as Exhibit 2. See Doc. 21727-2.
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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. CV-16-00474,
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Jones, No. CV-16-00782, and Hyde, No. CV-16-00893. The Court granted summary
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judgment in one of the bellwether cases, Kruse, No. CV-15-01634, and removed another
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from the bellwether trial schedule at the request of Plaintiffs, Mulkey, No. CV-16-00853.
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Docs. 12202, 13329. The final bellwether case, Tinlin, No. CV-16-00263, settled shortly
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before trial in May 2019. The Court determined that further bellwether trials were not
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necessary. Docs. 12853, 13329 (CMOs 38, 40).
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Bellwether Cases and Trials.
1.
Booker, No. CV-16-00474.
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The first bellwether trial concerned Plaintiff Sherr-Una Booker and involved a
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Bard G2 filter. The filter had tilted, migrated, and fractured. Plaintiff required open
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heart surgery to remove the fractured limbs and repair heart damage caused by a
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percutaneous removal attempt. Plaintiff withdrew her breach of warranty claims before
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Defendants moved for summary judgment. The Court granted Defendants’ motion for
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summary judgment on the claims for manufacturing defects, failure to recall,
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misrepresentation, negligence per se, and breach of warranty. Docs. 8873, 8874; see In
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re Bard IVC Filters Prods. Liab. Litig., No. CV-16-00474-PHX-DGC, 2017 WL
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5625548 (D. Ariz. Nov. 22, 2017). The remaining claims for failure to warn, design
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defect, and punitive damages were tried to a jury over a three-week period in March
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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
10
which $1.6 million was attributed to Defendants after apportionment of fault) and
11
$2 million in punitive damages. Id.; Doc. 10596. The Court denied Defendants’ motions
12
for judgment as a matter of law and a new trial. Docs. 10879, 11598; see In re Bard IVC
13
Filters Prods. Liab. Litig., No. CV-16-00474-PHX-DGC, 2018 WL 3037161 (D. Ariz.
14
June 19, 2018).
15
Defendants appealed, arguing that the Court erred by denying summary judgment
16
on their preemption defense, that a failure-to-warn claim was unavailable, and that the
17
award of punitive damages was not supported by the evidence. See Docs. 11934, 11953.
18
The Ninth Circuit affirmed. Docs. 21555, 21632; see In re Bard IVC Filters Prods. Liab.
19
Litig., 969 F.3d 1067 (9th Cir. 2020). The Ninth Circuit denied Defendants’ petition for
20
panel rehearing and rehearing en banc. See No. 18-16349, Doc. 84.2
21
2.
Jones, No. CV-16-00782.
22
The second bellwether trial concerned Plaintiff Doris Jones and involved a Bard
23
Eclipse filter. Plaintiffs withdrew the manufacturing defect, failure to recall, and breach
24
of warranty claims. The Court granted summary judgment on the misrepresentation,
25
negligence per se, and unfair trade practices claims. Doc. 10404; see In re Bard IVC
26
27
28
2
17916.
Plaintiff filed and later dismissed with prejudice a cross-appeal. Docs. 12070,
14
1
Filters Prods. Liab. Litig., No. CV-16-00782-PHX-DGC, 2018 WL 1256768 (D. Ariz.
2
Mar. 12, 2018). The remaining claims for failure to warn, design defect, and punitive
3
damages were tried to a jury over a three-week period in May 2018. The jury returned a
4
defense verdict. Doc. 11350. Plaintiff filed a motion to contact the jurors, which was
5
denied. Docs. 11663, 12068.
6
Plaintiff appealed the Court’s rulings excluding cephalad migration death
7
evidence. See Docs. 12057, 12071, 21554, 21610, 21656. The Ninth Circuit affirmed
8
those rulings. Docs. 21544, 21656; see In re Bard IVC Filters Prods. Liab. Litig., 816 F.
9
App’x 218 (9th Cir. 2020). The Ninth Circuit denied Plaintiff’s petition for rehearing en
10
11
banc. See No. 18-16461, Doc. 54.
3.
Kruse, No. CV-15-01634.
12
Plaintiff Carol Kruse’s case was set for trial in September 2018. The Court
13
granted Defendants’ summary judgment motion on statute of limitations grounds.
14
Doc. 12202; see In re Bard IVC Filters Prods. Liab. Litig., No. CV-15-01634-PHX-
15
DGC, 2018 WL 3957737 (D. Ariz. Aug. 17, 2018).
16
4.
Hyde, No. CV-16-00893.
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
19
the 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
21
Court granted summary judgment on the claims for breach of implied warranty, failure to
22
warn, failure to recall, misrepresentation, concealment, and fraud. Doc. 12007; see In re
23
Bard IVC Filters Prods. Liab. Litig., No. CV-16-00893-PHX-DGC, 2018 WL 3586404
24
(D. Ariz. July 26, 2018). The Court also entered judgment in favor of Defendants on the
25
negligence per se claim after concluding that it was impliedly preempted under 21 U.S.C.
26
§ 337(a). Doc. 12589; see In re Bard IVC Filters Prods. Liab. Litig., No. CV-16-00893-
27
PHX-DGC, 2018 WL 4356638 (D. Ariz. Sept. 12, 2018). The remaining claims for
28
design defect, loss of consortium, and punitive damages were tried to a jury over three
15
1
weeks in September 2018. After the close of Plaintiffs’ evidence, the Court granted in
2
part Defendants’ motion for judgment as a matter of law with respect to future damages
3
for any cardiac arrhythmia Ms. Hyde may experience, but denied the motion as to the
4
remaining claims. Doc. 12805; see In re Bard IVC Filters Prods. Liab. Litig., No. CV-
5
16-00893-PHX-DGC, 2018 WL 4742976 (D. Ariz. Oct. 2, 2018). The jury returned a
6
defense verdict. Doc. 12891. Plaintiff voluntarily dismissed her appeal. See Docs.
7
13465, 13480, 21732.
8
5.
Mulkey, No. CV-16-00853.
9
Plaintiff Debra Mulkey’s case involved an Eclipse filter and was set for trial in
10
February 2019. Before trial, Plaintiffs asked the Court to remove the Mulkey case from
11
the bellwether trial schedule because it was similar to the Jones and Hyde cases and
12
would not provide meaningful information to the parties.
13
granted the motion. Doc. 13329.
14
6.
Doc. 12990.
The Court
Tinlin, No. CV-16-00263.
15
The final bellwether trial concerned Plaintiff Debra Tinlin and involved a Bard
16
Recovery filter. Plaintiffs withdrew their claims for manufacturing defect, failure to
17
recall, negligence per se, and breach of warranty. The Court granted summary judgment
18
on the misrepresentation and deceptive trade practices claims.
19
remaining claims for failure to warn, design defect, concealment, loss of consortium, and
20
punitive damages were scheduled for trial in May 2019, but the case settled.
Doc. 17008.
The
21
H.
22
The Court has made many rulings in this MDL that could affect the remanded and
Key Legal and Evidentiary Rulings.
23
transferred cases.
24
evidentiary rulings to assist the courts that receive these cases.
25
1.
The Court provides the following summary of key legal and
Medical Monitoring Class Action Ruling.
26
In May 2016, Plaintiffs’ counsel filed a medical monitoring class action that was
27
consolidated with the MDL. See Barraza v. C. R. Bard, Inc., No. CV-16-01374-PHX-
28
DCG (D. Ariz. May 5, 2015). The Barraza Plaintiffs moved for class certification for
16
1
medical monitoring relief on behalf of themselves and classes of individuals who have
2
been implanted with a Bard IVC filter, have not had that filter removed, and have not
3
filed a claim or lawsuit for personal injury related to the filter. Id., Doc. 54. The Court
4
declined to certify the class. Id., Doc. 95.
5
The class certification motion recognized that only 16 states permit claims for
6
medical monitoring. The Court concluded that the classes could not be certified under
7
Rule 23(b)(3) because individual issues would predominate. Id. at 20-21. The Court
8
further concluded that the class could not be certified under Rule 23(b)(2) because the
9
medical monitoring relief primarily constituted monetary rather than injunctive relief, and
10
the class claims were not sufficiently cohesive to permit binding class-wide relief. Id.
11
at 21-32. Finally, the Court concluded that typicality under Rule 23(a)(3) had not been
12
established.
13
prejudice. Docs. 106, 107. No appeal has been filed.
14
Id. at 32-34.
2.
The Barazza Plaintiffs dismissed their claims without
Federal Preemption Ruling.
15
Defendants moved for summary judgment on the grounds that Plaintiffs’ state law
16
claims are expressly preempted by the Medical Device Amendments of 1976 (“MDA”),
17
21 U.S.C. § 360 et seq., and impliedly preempted by the MDA under the Supreme
18
Court’s conflict preemption principles.
19
Doc. 8872; see In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX
20
DGC, 2017 WL 5625547 (D. Ariz. Nov. 22, 2017).
Doc. 5396.
The Court denied the motion.
21
The MDA curtails state regulation of medical devices through a provision that
22
preempts state requirements that differ from or add to federal requirements. 21 U.S.C.
23
§ 360k. The Bard IVC filters at issue in this litigation were cleared for market by the
24
FDA through section “510k” review, which focuses primarily on equivalence rather than
25
safety and effectiveness. See § 360c(f)(1)(A).
26
The Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), held that
27
§ 360k does not preempt state law claims directed at medical devices cleared through
28
the 510(k) process because substantial equivalence review places no federal requirements
17
1
on a device. Id. at 492-94. Lohr also noted that the “510(k) process is focused on
2
equivalence, not safety.” Id. at 493 (emphasis in original). Although the Safe Medical
3
Devices Act of 1990 (“SMDA”), Pub. L. 101-629, injected safety and effectiveness
4
considerations into 510(k) review, it did so only comparatively. The Court found that
5
Lohr remains good law and that clearance of a product under 510(k) generally does not
6
preempt state common law claims. Doc. 8872 at 12-14.
7
The Court further found that Defendants failed to show that the 510(k) reviews for
8
Bard IVC filters imposed device-specific requirements as needed for preemption under
9
§ 360k. Id. at 14-20. Even if device-specific federal requirements could be ascertained,
10
Defendants made no showing that any particular state law claim is expressly preempted
11
by federal requirements. Id. at 21-22.
12
The Court concluded that Plaintiffs’ state law claims are not impliedly preempted
13
because Defendants failed to show that it is impossible to do under federal law what the
14
state laws require. Id. at 22-24. Defendants pursued their preemption arguments in the
15
Booker appeal. Docs. 11934, 11953. As noted, the Ninth Circuit affirmed the Court’s
16
preemption ruling. See Docs. 21555, 21632; In re Bard, 969 F.3d at 1072-76.
17
3.
The Lehmann Report Privilege and Work Product Rulings.
18
The Court granted Defendants’ motion for a protective order to prevent Plaintiffs
19
from using a December 15, 2004 report of Dr. John Lehmann. Doc. 699. Dr. Lehmann
20
provided various consulting services to Bard at different times. Following Bard’s receipt
21
of potential product liability claims involving the Recovery filter, Bard’s legal
22
department retained Dr. Lehmann in November 2004 to provide an assessment of the
23
risks associated with the Recovery filter and the extent of Bard’s legal exposure.
24
Dr. Lehmann prepared a written report of his findings at the request of the legal
25
department and in anticipation of litigation. The Court found the report to be protected
26
from disclosure by the work product doctrine. Id. at 4-12. The Court further found that
27
Plaintiffs had not shown a substantial need for the report or undue hardship if the report
28
18
1
was not disclosed. Id. at 13-15. The Court agreed with the parties that this ruling does
2
not alter any prior rulings by transferor judges in specific cases. Id. at 22.
3
4
5
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:
6
7
Daubert Order
Doc. Nos.
8
9
10
11
12
13
Plaintiffs’ Expert Dr. Thomas Kinney
9428, 10323
Plaintiffs’ Experts Drs. Scott Resnick, Robert
Vogelzang, Kush Desai, and Robert Lewandowski
9432
Plaintiffs’ Experts Drs. David Kessler and Suzanne
Parisian
9433
Plaintiffs’ Experts Drs. Thomas Kinney, Anne Christine
Roberts, and Sanjeeva Kalva
9434
Plaintiffs’ Expert Dr. Mark Eisenberg
9770
Plaintiffs’ Expert Dr. Derek Muehrcke
9771
Plaintiffs’ Expert Dr. Darren Hurst
9772
Plaintiffs’ Expert Dr. Rebecca Betensky
9773
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
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
19
1
Defendants’ Expert Dr. Christopher Morris
2
10230, 10231,
17285
3
5.
4
Motion in Limine Rulings.
a.
5
FDA Evidence (Cisson Motion).
6
In the Booker bellwether trial, Plaintiffs sought to exclude, under Federal Rules of
7
Evidence 402 and 403, evidence of the FDA’s 510(k) clearance of Bard IVC filters and
8
the lack of FDA enforcement action against Bard. Doc. 9529. The Court denied the
9
motion. Docs. 9881, 10323.
10
The Court found that under Georgia law, which applied in both the Booker and
11
Jones bellwether cases, compliance with federal regulations may not render a
12
manufacturer’s design choice immune from liability, but evidence of Bard’s compliance
13
with the 510(k) process was nonetheless relevant to the design defect and punitive
14
damages claims.
15
evidence might mislead the jury or result in a mini-trial. Id. at 5-6 (citing In re C.R.
16
Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig. (Cisson), No. 2:10-CV-01224, 2013 WL
17
3282926, at *2 (S.D.W. Va. June 27, 2013)). But the Court concluded that such concerns
18
could adequately be addressed by efficient management of the evidence and adherence to
19
the Court’s time limits for trial, and, if necessary, by a limiting instruction regarding the
20
nature of the 510(k) process. Id. at 6-7.3
Doc. 9881 at 3-4.
The Court acknowledged concerns that FDA
21
The Court noted that the absence of any evidence regarding the 510(k) process
22
would run the risk of confusing the jury, as many of the relevant events in this litigation
23
occurred in the context of the FDA’s 510(k) review of the Bard filters and are best
24
understood in that context. Doc. 9881 at 7. Nor was the Court convinced that all FDA
25
references could adequately be removed from the evidence. Id.
26
27
28
3
The Court did not find a limiting instruction necessary at the close of either the
Booker or Jones trials. See Doc. 10694 at 9.
20
1
The Court further concluded that it would not exclude evidence and arguments by
2
Defendants that the FDA took no enforcement action against Bard with respect to the G2
3
or Eclipse filters, or evidence regarding information Bard provided to the FDA in
4
connection with the 510(k) process. Docs. 10323 at 2-3 (Booker), 11011 at 4-5 (Jones).
5
The Court found that the evidence was relevant to the negligent design and punitive
6
damages claims under Georgia law. Id. The Court determined at trial that it had no basis
7
to conclude that the FDA’s lack of enforcement was intended by the FDA as an assertion,
8
and therefore declined to exclude the evidence as hearsay. Doc. 10568 at 87.
9
b.
FDA Warning Letter.
10
Defendants moved to exclude evidence of the July 13, 2015 FDA warning letter
11
issued to Bard. Doc. 9864 at 2-3. The Court granted the motion in part, excluding as
12
irrelevant topics 1, 2, 4(a), 4(b), 5, 6, 7, and 8 of the warning letter. Docs. 10258 at 6-8
13
(Booker), 10805 at 1 (Jones), 12736 (Hyde), 17401 at 10 (Tinlin). Topics 1 and 2
14
concern the Recovery Cone retrieval system; Topic 4(a) concerns the filter cleaning
15
process; and Topics 4(b), 5, 6, 7, and 8 concern the Denali Filter. The Court concluded
16
that none of these topics was relevant to the issues in the bellwether cases involving a G2
17
filter (Booker), an Eclipse filter (Jones), either a G2X or Eclipse filter (Hyde), and a
18
Recovery filter (Tinlin). Id.
19
The Court deferred ruling on the relevance of topic 3 until trial in all bellwether
20
cases. The Court found that topic 3, concerning Bard’s complaint handling and reporting
21
of adverse events with respect to the G2 and Eclipse filters, as well as the adequacy of
22
Bard’s evaluation of the root cause of the violations, was relevant to rebut the implication
23
at trial that the FDA took no action with respect to Bard IVC filters. See Doc. 10693
24
at 13-15; Doc. 11256. The Court concluded that the warning letter was admissible under
25
Federal Rule of Evidence 803(8), and was not barred as hearsay. Doc. 10258 at 7. The
26
Court further concluded that the probative value of topic 3 was not substantially
27
outweighed by the danger of unfair prejudice to Bard under Rule 403. Id. The Court
28
admitted the warning letter in redacted form during the three bellwether trials. See
21
1
Docs. 10565, 11256, 12736. The Court noted that topic 3 included reference to the G2,
2
the filter at issue in Booker, and reached similar conclusions in Jones and Hyde.
3
Doc. 17401 at 11. The parties disputed the relevance of topic 3 in Tinlin because it did
4
not include reference to the Recovery, the filter at issue in Tinlin. Id. The Court did not
5
decide this issue because the Tinlin case settled.
6
c.
Recovery Cephalad Migration Death Evidence.
7
Defendants moved to exclude evidence of cephalad migration (i.e., migration of
8
the filter toward the patient’s heart) by a Recovery filter resulting in patient death. The
9
Court denied the motion for the Booker bellwether trial, which involved a G2 filter.
10
Docs. 10258 at 4-5, 10323 at 4.
11
The Court granted the motion for the Jones bellwether trial, which involved an
12
Eclipse filter, and denied Plaintiff’s requests for reconsideration of the ruling before and
13
during the trial.
14
Doc. 11409 at 94-96. The Ninth Circuit affirmed those rulings. Docs. 21554, 21610,
15
21656; see In re Bard, 816 F. App’x at 219. The Ninth Circuit denied Plaintiff’s petition
16
for rehearing en banc. See No. 18-16461, Doc. 54.
See Docs. 10819, 10920, 11041, 11113, 11256, 11302; see also
17
The Court granted the motion for the Hyde bellwether trial, which involved either
18
a G2X or Eclipse filter. Doc. 12533 at 6-7. The Court denied Defendants’ motion in the
19
Tinlin case, which involved a Recovery filter. Doc. 17401 at 7-10.
20
The Court concluded for purposes of the Booker bellwether trial that evidence of
21
cephalad migrations by a Recovery filter resulting in patient death was necessary for the
22
jury to understand the issues that prompted creation and design of the next-generation G2
23
filter, and thus was relevant to Plaintiff’s design defect claims. Doc. 10323 at 4. In
24
addition, because the Recovery filter was the predicate device for the G2 filter in
25
Defendants’ 510(k) submission to the FDA, and Defendants asserted to the FDA that the
26
G2 was as safe and effective as the Recovery, the Court concluded that the safety and
27
effectiveness of the Recovery filter was at issue. Id. The Court was concerned, however,
28
that too heavy an emphasis on deaths caused by cephalad migration of the Recovery
22
1
filter – a kind of migration which did not occur in the G2 filter generally or the Booker
2
case specifically – would result in unfair prejudice to Defendants that substantially
3
outweighed the probative value of the evidence. Id. Defendants did not object during
4
trial that 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
7
filter was inadmissible because it was only marginally relevant to Plaintiff’s claims and
8
its marginal relevancy was substantially outweighed by the risk of unfair prejudice. See
9
Docs. 10819, 10920, 11041, 11113, 11256, 11302. This is because cephalad migration
10
did not continue in any significant degree beyond the Recovery filter; cephalad migration
11
deaths all occurred before the Recovery was taken off the market in late 2005; Ms. Jones
12
did not receive her Eclipse filter until 2010; the Recovery-related deaths said nothing
13
about three of Ms. Jones’ four claims (strict liability design defect and the failure to warn
14
claims); and instances of cephalad migration deaths were not substantially similar to
15
complications experienced by Ms. Jones and therefore did not meet the Georgia standard
16
for evidence on 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
25
references should be redacted from evidence presented during the Jones trial.
26
The Court balanced this concern with the competing concern that it would be
27
unfair for Defendants to present statistics about the Recovery filter and not allow
28
Plaintiffs to present competing evidence that included Recovery deaths.
23
See, e.g.,
1
Doc. 11391 at 12. Based on this concern, Plaintiffs argued at various points during the
2
trial that Defendants had opened the door to presenting evidence about Recovery
3
cephalad migration deaths. The Court repeatedly made fact-specific determinations on
4
this point, holding that even though Defendants presented some evidence that made the
5
Recovery evidence more relevant, the danger of unfair prejudice continued to
6
substantially outweigh the probative value of the cephalad migration death evidence. See
7
Docs. 11113, 11302; see also Doc. 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
17
did the cephalad migration deaths, which were eliminated by design changes in the G2,
18
shed light on Defendants’ state of mind when designing and marketing the G2X and
19
Eclipse filters. Id. at 7.
20
The Court concluded in the Tinlin case, which involved a Recovery filter, that
21
Recovery deaths and Defendants’ knowledge of those deaths were relevant to Plaintiffs’
22
design defect claim under Wisconsin law because they went directly to the Recovery’s
23
foreseeable risks of harm and whether it was unreasonably dangerous. Doc. 17401
24
at 7-8. The Court also concluded that the Recovery death evidence was relevant to
25
Plaintiffs’ failure to warn and concealment claims because it was probative on the
26
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
24
1
expert testimony from Defendants that the Recovery filter was safe and effective, the
2
Court concluded that substantial similarity was not required. Id. at 8-9. The Court
3
further concluded that the death evidence was relevant to Bard’s state of mind and to
4
show the reprehensibility of its alleged conduct for purposes of punitive damages. Id.
5
at 9-10. The Court reached a different conclusion in the Jones and Hyde cases because
6
cephalad migration deaths stopped when the Recovery was taken off the market in 2005,
7
and the deaths shed little light on Defendants’ state of mind when marketing different,
8
improved 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.
15
because Plaintiffs did not contend that the SNF was defective. Id. at 2. Plaintiffs also
16
had rebuttal evidence showing that reported failure rates for SNF were lower than
17
Recovery and G2 failure rates. Id. The Court ultimately concluded it would not preclude
18
Defendants from presenting its SNF evidence on the basis of a discovery ruling and
19
permitted Plaintiffs to make appropriate evidentiary objections at trial. Id. at 3.
20
e.
The Court foreclosed this discovery
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
26
would be unfairly prejudicial under Rule 403 to disclose to the jury that the experts
27
originally were retained by Bard.
28
Plaintiffs could use portions of the experts’ depositions that support Plaintiffs’ claims, but
Id. at 2-3.
25
The Court therefore concluded that
1
could not disclose to the jury that the experts originally were retained by Bard. Id. at 3.
2
The Court was concerned about the presentation of cumulative evidence, and therefore
3
required Plaintiffs to show that no other expert of similar qualifications was available or
4
that the unavailable expert had some unique testimony to contribute, before the
5
deposition of any withdrawn 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:4
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
25
26
27
28
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).
4
26
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
IVC filter cases or as a paid consultant to Bard. Docs. 10075 at 2-3, 10323
at 4.
• 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.
28
27
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
• 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.
• 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.
• Defendants’ MIL 2 in Jones: The Court excluded evidence and testimony of
other lawsuits against Bard. Id. at 11.
• 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.
• 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.
• Defendants’ MIL 3 in Hyde: The Court permitted evidence and testimony
that Bard’s SNF is a reasonable alternative design. Id. at 7.
• 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.
• Defendants’ MIL 6 in Hyde: The Court permitted evidence and testimony
regarding informed consent. Id. at 8-9.
• 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.
• 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.
• 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.
• 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.
28
28
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:5
4
5
Depo. Date
Doc. No(s).
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
14
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
6
7
Deponent
8
9
10
11
15
16
17
21
22
23
26
27
28
5
In addition to the depositions identified in the table above, the Court ruled on
numerous objections to case-specific deposition designations for trial.
29
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
7.
Subject Matter Jurisdiction Rulings.
24
The parties identified cases in the MDL for which federal subject matter
25
jurisdiction does not exist. Docs. 20210, 21410, 21552, 21995. No federal question
26
jurisdiction exists under 28 U.S.C. § 1331 because the master complaint asserts no
27
federal claim and the state law claims alleged in the complaint do not depend on the
28
resolution of a federal law question. Doc. 364 ¶¶ 166-349. For purposes of diversity
30
1
jurisdiction under 28 U.S.C. § 1332, Defendant C. R. Bard, Inc. is a citizen of New Jersey
2
and Defendant Bard Peripheral Vascular, Inc. is a citizen of Arizona. See id. ¶¶ 11-12.
3
Thus, complete diversity between the parties does not exist in any case where each
4
Defendant is a named party and Plaintiff is a resident of either Arizona or New Jersey.
5
See Doc. 20210-1.
6
Plaintiffs in most of the cases without subject matter jurisdiction agreed to a
7
dismissal without prejudice. See id. Plaintiffs in other cases opposed dismissal, but
8
provided no reason why the cases should not be dismissed. See id. The Court dismissed
9
without prejudice multiple cases for lack of subject matter jurisdiction. Docs. 20667,
10
21461, 21579, 21741, 22014. Some of these cases may be refiled in state court. See
11
Doc. 20210-1.
12
8.
Dismissal of Cases With Prejudice Under Rule 41(b).
13
In more than 100 cases in which no settlement decision has been made, the
14
Plaintiffs or their heirs either cannot be located or the Plaintiffs have been nonresponsive
15
to counsel’s repeated inquiries. See Doc. 22012. The Court has dismissed these cases
16
with prejudice for failure to prosecute. Doc. 22034 and amended at Doc. 22035
17
18
I.
Further Proceedings in Remanded or Transferred Cases.
1.
General Discovery.
19
Because all general fact and expert discovery has been completed in this MDL, the
20
courts receiving these cases need not be concerned with facilitating general expert,
21
corporate, and third-party discovery. This observation is not meant to restrict the power
22
of receiving courts for good cause or in the interest of justice to address issues that may
23
be unique and relevant in a remanded or transferred case.
24
2.
Case-Specific Discovery and Trial Preparation.
25
According to the parties, the status of the remaining discovery and other pretrial
26
issues for the cases being remanded or transferred, and the estimated time needed to
27
resolve such issues and make the cases ready for trial, will be determined on remand or
28
transfer. Final trial preparation in the bellwether trials was governed by certain Court
31
1
orders. See Docs. 8871, 10323, 10587, 11011, 11320, 11321, 11659, 11871, 12061,
2
12853, 12971.
3
J.
4
If the Panel agrees with the Court’s suggestion of remand of the cases listed on
5
Schedule A and issues a final remand order (“FRO”), the Clerk of the Court for this
6
District will issue a letter to the transferor courts, via email, setting out the process for
7
transferring the case. The letter and certified copy of the FRO will be sent to the
8
transferor courts’ email addresses.
Documents to Be Sent to Receiving Courts.
9
The parties have submitted a stipulated designation of record for remanded cases.
10
Doc. 21727-4; see J.P.M.L Rule 10.4(a). Upon receipt of the FRO, the Clerk of this
11
District shall transmit to the transferor court the following: (1) a copy of the individual
12
docket sheet for the remanded action, (2) a copy of the master docket sheet in this MDL,
13
(3) the entire file for the remanded action, as originally received from the transferor
14
district, and (4) the record on remand designated by the parties. See Doc. 21727-4;
15
J.P.M.L Rule 10.4(b).
16
The Court has concluded that the cases listed on Schedule B should be transferred
17
to appropriate districts pursuant to 28 U.S.C. § 1404(a). Upon receipt of this transfer
18
order, the Clerk for this District shall follow the same procedures prescribed above for
19
each of the individual cases listed on Schedule B.
20
If a party believes that the docket sheet for a particular case being remanded or
21
transferred is not correct, a party to that case may, with notice to all other parties in the
22
case, file with the receiving court a designation amending the record. Upon receiving
23
such designation, the receiving court may make any needed changes to the docket. If the
24
docket is revised to include additional documents, the parties should provide those
25
documents to the receiving court.
26
IV.
Conclusion.
27
Pursuant to J.P.M.L. Rule 10.1(b)(i), the Court suggests that the Panel remand the
28
cases listed on Schedule A to the transferor districts for further proceedings. The Clerk
32
1
shall forward a certified copy of this order to the Panel. Pursuant to 28 U.S.C. § 1404(a),
2
the Clerk of this District is directed to transfer the cases listed on Schedule B to
3
appropriate districts for further proceedings. The Clerk of this District is directed to
4
unconsolidate from the MDL the case listed on Schedule C. This case will remain in the
5
District of Arizona and be assigned to the undersigned judge.
6
IT IS SO ORDERED.
7
Dated this 26th day of April, 2021.
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
33
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule A – Cases to Be Remanded to Transferor Courts
(April 26, 2021)
Plaintiffs
Current Case Number
Taylor, Kendrick
2:15-cv-02463-PHX-DGC
Adams, Michael
2:19-cv-00927-PHX-DGC
Britt, Judy Ann
2:19-cv-00187-PHX-DGC
DeClemente, Constance C.
2:18-cv-02363-PHX-DGC
Rykowski, Lisamarie
2:19-cv-01887-PHX-DGC
Sparacino, Anna Marie
2:19-cv-02372-PHX-DGC
Atilla, Victoria C.
2:18-cv-02789-PHX-DGC
Bandura, Robert J.
2:19-cv-00233-PHX-DGC
Bedard, Barbara A.
2:19-cv-00232-PHX-DGC
Brown, Mary
2:18-cv-02982-PHX-DGC
1
Transferor Court and Case Number
Ala. S.D.
1:15-cv-00568-WS-B
Ca. E.D.
1:19-cv-00085
Ca. S.D.
3:18-cv-02560-L-LL
N.Y. E.D.
2:18-cv-03977
N.Y. E.D.
2:19-cv-00962
N.Y. S.D.
1:19-cv-02292
N.Y. W.D.
6:18-cv-06602
N.Y. W.D.
1:18-cv-01323
N.Y. W.D.
1:18-cv-01322
N.Y. W.D.
6:18-cv-06629-CJS
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule A – Cases to Be Remanded to Transferor Courts
(April 26, 2021)
Butterbaugh, Donald
2:18-cv-02790-PHX-DGC
Darrow, Donette C.
2:18-cv-02318-PHX-DGC
Dulski, Florence J
2:18-cv-02985-PHX-DGC
Ford, Diana L.
2:19-cv-01987-PHX-DGC
Golden, Margaret S
2:19-cv-01773-PHX-DGC
Groomes, David E. Jr.
2:18-cv-02983-PHX-DGC
Headley, Helen L.
2:19-cv-00854-PHX-DGC
Hunter, Thomas L.
2:19-cv-00855-PHX-DGC
Kelman, William
2:18-cv-04044-PHX-DGC
Loucks, Michael R.
2:19-cv-00856-PHX-DGC
Marchese, Ruben
2:18-cv-02984-PHX-DGC
Miraglia, Nicholas R.
2:19-cv-01886-PHX-DGC
Palmer, Herman L. Sr.
2:19-cv-01986-PHX-DGC
2
N.Y. W.D.
6:18-cv-06603
N.Y. W.D.
1:18-cv-00715-CJS-MWP
N.Y. W.D.
1:18-cv-00970-WMS
N.Y. W.D.
1:19-cv-00327
N.Y. W.D.
6:19-cv-06125
N.Y. W.D.
1:18-cv-00960-LJV
N.Y. W.D.
1:19-cv-00087
N.Y. W.D.
6:19-cv-06048
N.Y. W.D.
1:18-cv-01173
N.Y. W.D.
6:19-cv-06049
N.Y. W.D.
1:18-cv-00969-LJV
N.Y. W.D.
6:19-cv-06126
N.Y. W.D.
1:19-cv-00326
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule A – Cases to Be Remanded to Transferor Courts
(April 26, 2021)
Russell, Christopher L.
2:19-cv-00857-PHX-DGC
Sestokas, David Gerard
2:19-cv-00234-PHX-DGC
Stefanik, Regan Douglas
2:19-cv-00235-PHX-DGC
Teeter, Brian J.
2:18-cv-02362-PHX-DGC
Edwards, Myra Dawn
2:15-cv-02090-PHX-DGC
3
N.Y. W.D.
6:19-cv-06052
N.Y. W.D.
1:18-cv-01337
N.Y. W.D.
1:18-cv-01338
N.Y. W.D.
6:18-cv-06520
Va. W.D.
7:15-cv-00515
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Plaintiff
Current Case Number
Transferee Court
Lambert, Leoma C.
2:17-cv-01359-PHX-DGC
Ark. E.D.
Trammell, Joseph
2:19-cv-03782-PHX-DGC
Ark. E.D.
Whitmore, Carrie Jo
2:17-cv-01353-PHX-DGC
Ariz.
Black, Karen Sue
2:19-cv-01258-PHX-DGC
Cal. C.D.
Bull, Michael
2:19-cv-02702-PHX-DGC
Cal. C.D.
Dominguez, Dora
2:18-cv-01488-PHX-DGC
Cal. C.D.
Gonzalez, Jessie J.
2:19-cv-02366-PHX-DGC
Cal. C.D.
Italiane, Frank Lane
2:19-cv-03348-PHX-DGC
Cal. C.D.
Najarro, Didy
2:19-cv-03119-PHX-DGC
Cal. C.D.
Walker, Justin M
2:19-cv-02945-PHX-DGC
Cal. C.D.
Wetzel, David J.
2:19-cv-03719-PHX-DGC
Cal. C.D.
Ferroni, Jill Ann
2:17-cv-01386-PHX-DGC
Cal. E.D.
Johnson, Janice L.
2:16-cv-03899-PHX-DGC
Cal. E.D.
Menez, Donald
2:16-cv-01207-PHX-DGC
Cal. E.D.
1
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Gauntt, James L.
2:18-cv-04155-PHX-DGC
Cal. S.D.
Mancuso, Felicia M.
2:19-cv-02775-PHX-DGC
Cal. S.D.
Smith, Edward L.
2:17-cv-01361-PHX-DGC
Cal. S.D.
Armstrong, Antion
2:18-cv-00968-PHX-DGC
Fla. M.D.
Barraza, Maria Milagros
2:18-cv-03098-PHX-DGC
Fla. M.D.
Dougal, Robert
2:16-cv-00180-PHX-DGC
Fla. M.D.
Fleming, Eddie
2:19-cv-01541-PHX-DGC
Fla. M.D.
Freeman, Nicko TaWanda
2:18-cv-03102-PHX-DGC
Fla. M.D.
Gibson, Judy K.
2:16-cv-00181-PHX-DGC
Fla. M.D.
Remache, Shannon Lee
2:18-cv-03109-PHX-DGC
Fla. M.D.
Smith, Stephanie
2:19-cv-02267-PHX-DGC
Fla. M.D.
Vincent, Patrick E.
2:18-cv-03807-PHX-DGC
Fla. M.D.
Ward, Richard Carl
2:17-cv-01356-PHX-DGC
Fla. M.D.
Brown, Donald on behalf of
Watson, Virginia
2:17-cv-01383-PHX-DGC
Fla. M.D.
Williams, Amanda L.
2:18-cv-01046-PHX-DGC
Fla. M.D.
Waser, Jason John
2:18-cv-03113-PHX-DGC
Fla. N.D.
2
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Baker, Adam
2:19-cv-00556-PHX-DGC
Fla. S.D.
Hall, Matthew
2:16-cv-01363-PHX-DGC
Fla. S.D.
Pryor, Valerie Elizabeth
2:16-cv-01240-PHX-DGC
Fla. S.D.
Wilson, Alice
2:18-cv-03097-PHX-DGC
Fla. S.D.
Garrett, Randy
2:16-cv-02122-PHX-DGC
Ga. M.D.
Redding, Felicia L.
2:18-cv-03107-PHX-DGC
Ga. M.D.
Hill, Victavia
2:16-cv-02123-PHX-DGC
Ga. N.D.
Townley, Brenda
2:16-cv-01359-PHX-DGC
Ga. N.D.
Williams, Michael Shane
2:18-cv-04205-PHX-DGC
Ga. N.D.
Lynch, Lina Mireya
2:16-cv-02130-PHX-DGC
Ga. S.D.
Barrett, Lori
2:17-cv-04481-PHX-DGC
Iowa
Gharrett, Kim
2:19-cv-03170-PHX-DGC
Ill. C.D.
Sell, Tiffany
2:16-cv-01241-PHX-DGC
Ill. N.D.
Cash, Mark A.
2:16-cv-03462-PHX-DGC
Ind. N.D.
Beasley, Paul F.
2:18-cv-03079-PHX-DGC
Kan.
Chapman, Larry Darnell
2:18-cv-04151-PHX-DGC
Ky. E.D.
3
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Eastman, Jr, Edmund
2:16-cv-03760-PHX-DGC
La. E.D.
Richard, Mario M.
2:18-cv-03093-PHX-DGC
La. E.D.
Smith, Brenda Duncan
2:17-cv-01388-PHX-DGC
La. M.D.
Bicica, Kirsten Jessica
2:16-cv-00177-PHX-DGC
Mass.
Siegfried, Tammie
2:18-cv-04201-PHX-DGC
Mass.
Walton, Winston L.
2:18-cv-04203-PHX-DGC
Mass.
Gardner, Raymond
2:19-cv-00045-PHX-DGC
M.D.
Scott, Elouise
2:18-cv-02763-PHX-DGC
M.D.
Ward, Jack McKinley
2:17-cv-01357-PHX-DGC
M.D.
Williams, Anthony
2:16-cv-01361-PHX-DGC
M.D.
Cady, Jr, Irvin L.
2:18-cv-03099-PHX-DGC
Mich. E.D.
Przykucki, Robert
2:19-cv-03736-PHX-DGC
Mich. E.D.
Stokely, Kristen A.
2:17-cv-03385-PHX-DGC
Mich. E.D.
Williams, Stephanie A.
2:17-cv-01360-PHX-DGC
Mich. E.D.
Bethea, Katina
2:18-cv-04199-PHX-DGC
Mich. W.D.
El-Amin, RaSheedah NuMan
2:17-cv-01358-PHX-DGC
Minn.
4
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Lashley, Ken
2:18-cv-01646-PHX-DGC
Mo. E.D.
Powell, Mylus
2:19-cv-04072-PHX-DGC
Mo. E.D.
Miller, Linda
2:17-cv-00370-PHX-DGC
Mo. W.D.
Johnson, Andrew Lee
2:16-cv-03816-PHX-DGC
Miss. S.D.
Patterson, Patricia Ann
2:18-cv-03106-PHX-DGC
Miss. S.D.
Perry, Russell Seward
2:18-cv-02831-PHX-DGC
Miss. S.D.
Prince, James D.
2:18-cv-03199-PHX-DGC
Miss. S.D.
Spane, Jennifer Bonita
2:18-cv-01581-PHX-DGC
Miss. S.D.
Townsend, Benjamin
2:16-cv-01384-PHX-DGC
Miss. S.D.
Braden, Kevin
2:17-cv-00047-PHX-DGC
Mont.
Ross, Brian
2:18-cv-03092-PHX-DGC
Neb. E.D.
Tuck, Dariel
2:18-cv-04202-PHX-DGC
N.C. E.D.
Graham, James
2:18-cv-03103-PHX-DGC
N.C. M.D.
Hopkins, Michael
2:19-cv-03641-PHX-DGC
N.C. M.D.
Rosengrant, Kristen Marie
2:19-cv-02696-PHX-DGC
N.C. M.D.
Howard, Deborah
2:16-cv-01223-PHX-DGC
N.C. W.D.
5
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Dahl, Amy Elizabeth
2:18-cv-03101-PHX-DGC
Nev.
Dostie, Jr, Robert William
2:18-cv-04152-PHX-DGC
N.H.
Arp, Brigitte
2:19-cv-03258-PHX-DGC
N.M.
Martel, Shirley
2:16-cv-01242-PHX-DGC
Nev.
Shaw, Rick Anthony
2:18-cv-01593-PHX-DGC
Nev.
Currenti, Kerry Ann
2:18-cv-02761-PHX-DGC
N.Y. E.D.
Leary, Kevin
2:16-cv-02128-PHX-DGC
N.Y. E.D.
Morales, Dora M.
2:19-cv-02943-PHX-DGC
N.Y. E.D.
Jenkins, Lisa A.
2:17-cv-00201-PHX-DGC
N.Y. N.D.
Krell, Amy L.
2:19-cv-02779-PHX-DGC
N.Y. N.D.
McCoy, Kelly
2:18-cv-03466-PHX-DGC
N.Y. N.D.
Moss, Diana
2:18-cv-00032-PHX-DGC
N.Y. N.D.
Szymanoski, Steven Stanley
2:19-cv-02931-PHX-DGC
N.Y. N.D.
Caceres, Nanette
2:19-cv-02365-PHX-DGC
N.Y. S.D.
Hoffler, Donna M.
2:18-cv-03087-PHX-DGC
N.Y. S.D.
Thomas, Karen S.
2:16-cv-00090-PHX-DGC
N.Y. S.D.
6
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Cottone, Josephine R.
2:19-cv-03220-PHX-DGC
N.Y. W.D.
Edwards, Antoine
2:19-cv-03722-PHX-DGC
N.Y. W.D.
McMahon, David M.
2:19-cv-02783-PHX-DGC
N.Y. W.D.
Parkinson, Emmily
2:19-cv-02944-PHX-DGC
N.Y. W.D.
McCorkle, Samuel A.
2:18-cv-03090-PHX-DGC
Ohio N.D.
Newson, Michael
2:17-cv-00869-PHX-DGC
Ohio N.D.
Sweet, Margaret C
2:18-cv-03095-PHX-DGC
Ohio N.D.
Hayes, Susan
2:16-cv-00182-PHX-DGC
Ohio. S.D.
McGhee, Kenya
2:16-cv-01238-PHX-DGC
Ohio S.D.
Narayan, Ashwin A.
2:16-cv-00617-PHX-DGC
Ohio S.D.
Garner, Carrie Leena
2:18-cv-03085-PHX-DGC
Okla. E.D.
Dobson, Delores
2:17-cv-04311-PHX-DGC
Okla. N.D.
Riggs, Waynetta Sharon
2:17-cv-03325-PHX-DGC
Okla. W.D.
Carter, Cheyenne
2:16-cv-00178-PHX-DGC
Ore.
Kiley, Nancy
2:16-cv-01239-PHX-DGC
Pa. E.D.
Krause, William E.
2:18-cv-03104-PHX-DGC
Pa. E.D.
7
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Martz, Mandie C.
2:18-cv-03089-PHX-DGC
Pa. E.D.
Himes-Fox, Cherie
2:18-cv-04158-PHX-DGC
Pa. M.D.
Williams, Stanley J.
2:19-cv-04254-PHX-DGC
Pa. M.D.
Levine, Benjamin I.
2:18-cv-03105-PHX-DGC
Pa. W.D.
Showalter, Shirley
2:18-cv-03112-PHX-DGC
Pa. W.D.
Horowitz, Philip R.
2:18-cv-04161-PHX-DGC
S.C.
Medes, Charles B.
2:19-cv-03827-PHX-DGC
S.C.
White, Peggy Marie
2:18-cv-04204-PHX-DGC
S.C.
Janes, Debora L.
2:16-cv-03901-PHX-DGC
S.D.
Stricklin, Lois Ann
2:17-cv-04516-PHX-DGC
Tenn. E.D.
Hopkins, Marsha Ann
2:17-cv-01436-PHX-DGC
Tenn. M.D.
McCartney, Lester Dale
2:17-cv-00126-PHX-DGC
Tenn. M.D.
Carter, Sandra Lee
2:18-cv-03100-PHX-DGC
Tenn. W.D.
Hammond, Lorella N.
2:18-cv-03086-PHX-DGC
Tenn. W.D.
Hinson, Larry
2:19-cv-04082-PHX-DGC
Tenn. W.D.
Schaaf, Julie A.
2:18-cv-03784-PHX-DGC
Tenn. W.D.
8
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Burgess, Keith Allen
2:18-cv-03911-PHX-DGC
Tex. E.D.
Crissey, Martin
2:16-cv-01362-PHX-DGC
Tex. E.D.
Finnels, Sr, Calvin Lee
2:17-cv-01382-PHX-DGC
Tex. E.D.
McCoy, Chani
2:18-cv-01908-PHX-DGC
Tex. E.D.
Stansell, Jason
2:17-cv-01079-PHX-DGC
Tex. E.D.
Taylor, Joseph Frank
2:19-cv-02699-PHX-DGC
Tex. E.D.
Waggoner, Shari
2:18-cv-04329-PHX-DGC
Tex. E.D.
Anderson, Theresa
2:19-cv-00378-PHX-DGC
Tex. N.D.
Flippin, Freddie O.
2:17-cv-01387-PHX-DGC
Tex. N.D.
Lopez, Joe
2:16-cv-01358-PHX-DGC
Tex. N.D.
Lyle, Jack Lee
2:16-cv-02129-PHX-DGC
Tex. N.D.
Hall, Joyce
2:16-cv-00851-PHX-DGC
Tex. S.D.
Hinojosa, Venessa
2:16-cv-02124-PHX-DGC
Tex. S.D.
Collins, Sr, Arthur Lee
2:18-cv-03081-PHX-DGC
Tex. W.D.
Curry, Kimberly
2:16-cv-00179-PHX-DGC
Tex. W.D.
Lazenby, Mary Juanita
2:17-cv-04087-PHX-DGC
Utah
9
In Re Bard IVC Filter Products Liability Litigation, No. MDL 15-2641
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule B – Direct-Filed Cases to Be Transferred
(April 26, 2021)
Langley, Shana
2:19-cv-03765-PHX-DGC
Va. E.D.
Nason, Erin Heather
2:18-cv-03091-PHX-DGC
Va. E.D.
Wheeler, Kyle A.
2:19-cv-00099-PHX-DGC
Va. E.D.
Chance, Laura
2:16-cv-03627-PHX-DGC
Va. W.D.
Huff, Star
2:16-cv-01243-PHX-DGC
Va. W.D.
Weatherford, Garry
2:19-cv-03779-PHX-DGC
Va. W.D.
Wertz, Elisha Belle
2:17-cv-01389-PHX-DGC
Va. W.D.
Nelson, Ruth E.
2:17-cv-01384-PHX-DGC
Wisc. E.D.
Harwell, Cindy Lou
2:16-cv-01364-PHX-DGC
Wisc. W.D.
Meier, Jerold I.
2:17-cv-02128-PHX-DGC
Wisc. W.D.
10
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
AMENDED SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Schedule C – Arizona Case to Be Unconsolidated from the MDL
(April 26, 2021)
Case Caption
Carrie Whitmore
Case Number
2:17-cv-01353
Plaintiff’s Residence Proper Venue
AZ
D. Ariz.
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
TRANSFER ORDER (SIXTH)
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
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
CASE MANAGEMENT ORDERS (CMOs)
Date Filed
Doc. No
Docket Text
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
2
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
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
CASE MANAGEMENT ORDERS (CMOs)
Date Filed
Doc. No
Docket Text
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
3
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
05/16/2019
17777
CMO 44 re Common Benefit Fund Accounts
05/31/2019
18079
CMO 45 re MDL Closure
08/20/2019
21480
CMO 46 re Common Benefit Fee and Cost Committee (Sealed Ex
Parte Order)
10/17/2019
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
Docket 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
DISCOVERY ORDERS
Date Filed
Docket No
Docket Text
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
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
4
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
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
DISCOVERY ORDERS
Date Filed
Docket No
05/19/2017
5883
Docket Text
Amended CMO 24 re Discovery Protocols for Bellwether Group 1
5
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
DISCOVERY AND PRIVILEGE ORDERS
Date Filed
Docket 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
Docket 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
6
DAUBERT ORDERS
Date Filed
Docket No
Docket Text
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
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
Docket No
01/23/2018
9775
Docket Text
CMO 30 re Motions Hearings, Motions in Limine, and Punitive
Damages in Booker
7
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
MOTIONS IN LIMINE ORDERS
Date Filed
Docket No
Docket Text
Produced in Complaint Files, Prior Judicial Opinions, Adverse
Impact of a Plaintiff's Verdict, Informed Consent 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
8
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
04/23/2019
17285
Order re medical care as an intervening cause of injury for Tinlin
Bellwether case
MOTIONS IN LIMINE ORDERS
Date Filed
Docket No
04/26/2019
17401
Docket Text
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
Docket 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
9
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
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
Docket 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.
10
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
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
MISCELLANEOUS ORDERS
Date Filed
Docket No
Docket Text
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
11
09/08/2020
21579
Order Addressing Cases with Service of Process and Plaintiff
Profile Form Issues, Cases for Which No Federal Jurisdiction
Exists, and Duplicate Cases
MASTER AND SHORT-FORM PLEADINGS
Date Filed
Docket 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
303-2
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
Master Short Form Complaint for Damages for Individual Claims
12
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
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 Exh. 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)
1
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
559
Trial Ex.
No.
Asch Exh. 210, BPV-17-01-00052621, 4/17/2002- Email from George Cavagnaro to Doug Uelmen and Carol
Vierling, dated April 18, 2002
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 CCed, 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
2
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
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
769
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
Carr Deposition, 12/19/2013 - Exhibit 05 - BPV Meridian Claims Matrix, dated 7/2/2010
3
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
770
Carr Deposition, 12/19/2013 - Exhibit 06 - Bard's Denali Concept Product Opportunity Appraisal, POA8108, 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
Trial Ex.
No.
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
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
927
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)
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
4
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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.
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
5
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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, FIR-04-12-01 Rev. 00
1023
1031
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
1036
Trial Ex.
No.
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 CCedd, Re. "Comments on Rev
Notes
Description
H". Discussion about concern for over-reporting of the SIR guidelines re- classification and removal of the
retroperitoneal bleed, and replacing consultant John Lehmann
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
6
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
1219
Trial Ex.
No.
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",
RA-STD-002 Rev. 08, dated 10/12/2000
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"
Notes
Description
1220
REDACTED
Ganser Deposition, 10/11/2016 - Exhibit 530 - 8/25/2004 E-mail from Avijit Mukherjee to Robert Carr,
Janet Hudnall Cced, 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"
1222
REDACTED
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
7
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
Trial Ex.
No.
Notes
Description
1568
Kessler Report - September 30, 2010 memo from Brett Baird to Eclipse DRT, with the subject line “Eclipse
Post-Market 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
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”
8
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
Trial Ex.
No.
1680
1740
Notes
REDACTED
Description
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
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"
9
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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)
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, RajiKubba,
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
Trial Ex.
No.
1912
Only admitted Pgs.
38 & 70
Randall, 01/18/2017, Exhibit 634 - Binder labeled "Meridian Design History File DHF, Vol. II"
Notes
Description
Romney Deposition, 09/07/2016 - Exhibit 2039 3/16/2006 E-mail from Jason Greer to Janet Hudnall
10
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
1926
Romney, 01/18/2017, Exhibit 2061 - 8/6/2014 E-mail from Schyler Smith, Field Manager for BPV in
Washington-Idaho-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)
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
11
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial Ex.
No.
Notes
Description
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
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"
2059
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
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"
12
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial Ex.
No.
Notes
Description
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
kaufmajo@ohsu.edu, 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 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
13
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
2245
Trial Ex.
No.
Wong Exh. 540, Recovery Gen 1, Fracture and Migration Complaint Update, 6-20-2006
Notes
Description
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 8-106, 8-4-2006
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
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"
14
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
Trial Ex.
No.
3304
Notes
REDACTED
Description
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 Murrary 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
4428
REDACTED
Meridian Vena Cava Filter and Jugular Delivery System Product Performance Specification PPS, Revision 3
Eclipse Vena Cava Filter Ad
15
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
Trial Ex.
No.
Notes
Description
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
16
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
4515
Only admitted pgs.
12 & 13
Monthly Management Report, dated 4/8/10
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
Trial Ex.
No.
4534
Notes
REDACTED
Description
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
17
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
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
Trial Ex.
No.
Notes
Description
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)
18
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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)
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)
Trial Ex.
No.
Notes
Description
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)
19
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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)
5169
REDACTED
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)
Trial Ex.
No.
Notes
Description
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
20
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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)
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
Trial Ex.
No.
Notes
Description
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)
21
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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-17-0100123498 -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)
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)
Trial Ex.
No.
5350
Notes
REDACTED
Description
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)
22
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
TPR04-02-02) ETR-04-03-05, Rev. 0 (GFO and NMT Manufactured Recovery; Filters Migration Resistance
Comparison, Phase 1)
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
Trial Ex.
No.
Notes
5537
5539
Description
June 2006 Expert Panel Meeting Slides
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
23
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
5560
Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 Rev 11, BPV-170100166749 - 776.
5561
Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 Rev 12, BPV-17-0100166777 -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
5706
Only admitted pgs.
48-61
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
Trial Ex.
No.
5877
Notes
Description
1996 Memo from Veronica Price
24
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
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
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
25
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial Ex.
No.
Notes
Description
6082
FDA_PRODUCTION_00001288 -- July 2, 2003 Email chain FDA and BPV re Recovery Retrievable
(K031328)
6089
Product Development Cycle PPT
6842
“Admitted for the
limited purpose to
establish knowledge
to the medical
community, not for
the truth of the matter
asserted.”
ACR-SIR-SPR Practice Parameter for the Performance of Inferior Vena Cava (IVC) Filter Placement for the
Prevention of Pulmonary Embolism. Revised 2016.
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
“Admitted for the
limited purpose to
establish knowledge
to the medical
community, not for
SIR Guidelines for IVC Filters
26
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
Trial Ex.
No.
Notes
Description
the truth of the matter
asserted.”
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
27
In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC
SUGGESTION OF REMAND AND TRANSFER ORDER (SIXTH)
Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order
8546
Draft Test Report re Rotary Beam Fatigue of Nitinol Wire
8572
G3 Meeting Minutes Nov 27, 2007
Trial Ex.
No.
Notes
Description
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
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
28
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