Easton v. C R Bard Incorporated et al

Filing 3

TRANSFER ORDER (FOURTH) - ORDERED Pursuant to 28 U.S.C. § 1404(a), the Clerk of this District is directed to transfer the cases listed on Schedule A to appropriate districts for further proceedings. FURTHER ORDERED the Clerk of this District is directed to unconsolidated from the MDL: Lonnie Easton v. C. R. Bard, Inc., No. 2:19-cv-04274. This case to remain in the District of Arizona and be assigned to the undersigned judge. See Order for Details. Signed by Senior Judge David G Campbell on 9/10/20. (MAP)

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1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 9 10 IN RE: Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) 11 12 13 14 This multidistrict litigation proceeding (“MDL”) involves personal injury cases 15 brought against Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. 16 (collectively, “Bard”). Bard manufactures and markets medical devices, including inferior 17 vena cava (“IVC”) filters. The MDL Plaintiffs have received implants of Bard IVC filters 18 and claim they are defective and have caused Plaintiffs to suffer serious injury or death. 19 The MDL was transferred to this Court in August 2015 when 22 cases had been 20 filed. Doc. 1. More than 8,000 cases had been filed when the MDL closed on May 31, 21 2019. Docs. 18079, 18128. Thousands of cases pending in the MDL have settled or are 22 near settlement. See Docs. 16343, 19445, 19798, 21167, 21410. The remaining cases no 23 longer benefit from centralized proceedings. 24 On August 20, 2019, the Court suggested the remand of 35 cases that were 25 transferred to this MDL by the United States Judicial Panel for Multidistrict Litigation 26 (the “Panel”), and transferred more than 500 cases that were directly filed in the MDL to 27 appropriate districts. Doc. 19899 at 2-6, 34-59. The Court suggested the remand of another 28 case and transferred nearly 400 cases on October 17, 2019. Doc. 20672 at 2-4, 32-48. On 1 March 4, 2020, the Court suggested the remand of 30 cases and transferred more than 1,000 2 cases. Doc. 21462 at 2-4, 33-74 (as amended by Docs. 21463, 21472). 3 In an updated report on the settlement status of cases, the parties identify more than 4 100 pending cases that are not likely to settle. Docs. 21552 at 2, 21552-2. These cases – 5 which were directly filed in the MDL – will be transferred to appropriate districts pursuant 6 to 28 U.S.C. § 1404(a). The cases to be transferred are listed on Schedule A to this order. 7 Two other cases – Bernadette McBride v. C. R. Bard, Inc., No. 2:19-cv-02819, and Lonnie 8 Easton v. C. R. Bard, Inc., No. 2:19-cv-04274 – will be unconsolidated from the MDL, 9 will remain in the District of Arizona, and will be assigned to the undersigned judge. See 10 Doc. 21552-2 at 1, 3. 11 To assist the transferee courts, this order will describe events that have taken place 12 in the MDL. A copy of this order, along with the case files and materials, will be available 13 to courts after transfer. 14 I. Transfer Under 28 U.S.C. § 1404(a). 15 Pursuant to Case Management Order No. 4 (“CMO 4”), cases were filed directly in 16 the MDL through use of a short form complaint. Doc. 363 at 3 (as amended by Docs. 1108, 17 1485). Plaintiffs were required to identify in the short form complaint the district where 18 venue would be proper absent direct filing in the MDL. See id. at 7. CMO 4 provides that, 19 upon the MDL’s closure, each pending direct-filed case shall be transferred to the district 20 identified in the short form complaint. Id. at 3. 21 Section 1404(a) provides that “[f]or the convenience of parties and witnesses, in the 22 interest of justice, a district court may transfer any civil action to any other district or 23 division where it might have been brought or to any district or division to which all parties 24 have consented.” Pursuant to § 1404(a), the Court will transfer the cases listed on Schedule 25 A to the districts identified in the short form complaints. See In re Biomet M2a Magnum 26 Hip Implant Prods. Liab. Litig., No. 3:12-MD-2391, 2018 WL 7683307, at *1 (N.D. Ind. 27 Sept. 6, 2018) (transferring cases under § 1404(a) where they would “no longer benefit 28 from centralized proceedings[] and the remaining case-specific issues are best left to -2- 1 decision by the courts that will try the cases”). Defendants’ right to challenge venue and 2 personal jurisdiction upon transfer is preserved. See Docs. 19899 at 4-6, 20672 at 4, 21426 3 at 4. 4 II. The MDL Proceedings. 5 A summary of the MDL proceedings is provided below to assist courts receiving 6 transfers under § 1404(a). CMOs, discovery orders, and other significant rulings are listed 7 in Exhibit 1. The status of the remaining case-specific discovery and other pretrial issues 8 in individual cases should be addressed by the transferee courts. 9 A. Plaintiffs’ Claims and the Pleadings. 10 The IVC is a large vein that returns blood to the heart from the lower body. An IVC 11 filter is a small device implanted in the IVC to catch blood clots before they reach the heart 12 and lungs. This MDL involves multiple versions of Bard’s retrievable IVC filters – the 13 Recovery, G2, G2X, Eclipse, Meridian, and Denali. These filters are umbrella-shaped 14 devices that have multiple limbs fanning out from a cone-shaped head. The limbs consist 15 of legs with hooks that attach to the IVC wall and curved arms to catch or break up blood 16 clots. Each of these filters is a variation of its predecessor.1 17 The MDL Plaintiffs allege that Bard filters are more dangerous than other IVC 18 filters because they have higher risks of tilting, perforating the IVC, or fracturing and 19 migrating to vital organs. Plaintiffs further allege that Bard failed to warn patients and 20 physicians about these higher risks. Defendants dispute these allegations, contending that 21 Bard filters are safe and effective, that their complication rates are low and comparable to 22 those of other IVC filters, and that the medical community is aware of the risks associated 23 with IVC filters. 24 CMO 2, entered October 30, 2015, required the creation of a master complaint, a 25 master answer, and templates of short-form complaints and answers. Doc. 249 at 6. The 26 1 27 28 In early 2019, Defendants moved to expand the scope of the MDL to include cases concerning Bard’s Simon Nitinol Filter (“SNF”), a permanent device that predated the other filters in this litigation. The Panel denied the motion as moot because more than 80 SNF cases already had been filed in the MDL. None of the SNF cases are subject to this order. -3- 1 master complaint and answer were filed December 12, 2015. Docs. 364, 366. They are 2 the operative pleadings for most of the cases in this MDL. 3 The master complaint gives notice, pursuant to Rule 8, of the allegations that 4 Plaintiffs assert generally. The master complaint contains seventeen state law claims: 5 manufacturing defect (Counts I and V); failure to warn (Counts II and VII); design defect 6 (Counts III and IV); failure to recall (Count VI); misrepresentation (Counts VIII and XII); 7 negligence per se (Count IX); breach of warranty (Counts X and XI); concealment (Count 8 XIII); consumer fraud and deceptive trade practices (Count XIV); loss of consortium 9 (Count XV); and wrongful death and survival (Counts XVI and XVII). Doc. 364 at 34-63. 10 Plaintiffs seek both compensatory and punitive damages. Id. at 63. 11 Plaintiff-specific allegations are contained in individual short-form complaints or 12 certain complaints served on Defendants before the filing of the master complaint. See 13 Docs. 249, 363, 365. Plaintiffs also provided Defendants with profile forms and fact sheets 14 that describe their individual claims and conditions. See Doc. 365. 15 B. Case Management Orders. 16 The primary orders governing pretrial management of this MDL are a series 17 of CMOs, along with certain amendments. To date, the Court has issued 47 CMOs. These 18 orders are discussed below and can be found on this District’s website at 19 http://www.azd.uscourts.gov/case-info/bard. 20 C. 21 CMO 1, entered October 30, 2015, appointed Co-Lead/Liaison Counsel for 22 Plaintiffs (“Lead Counsel”) to manage the litigation on behalf of Plaintiffs, and set out the 23 responsibilities of Lead Counsel. Doc. 248. Plaintiffs’ Lead Counsel has changed since 24 the inception of the MDL. Mr. Ramon Lopez, of Lopez McHugh, LLP, in Newport Beach, 25 California, and Mr. Mark O’Connor, of Beus Gilbert McGroder PLLC, in Phoenix, 26 Arizona, are now Lead Counsel for Plaintiffs. Doc. 5285. Mr. Richard North of Nelson 27 Mullins Riley & Scarborough, LLP, in Atlanta, Georgia, is Defendants’ Lead Counsel. 28 D. Lead Counsel. Plaintiffs’ Steering Committee and Common Benefits Fund. -4- 1 CMO 1 directed the selection and appointment of a Plaintiffs’ Steering Committee 2 (“PSC”) to assist in the coordination of pretrial activities and trial planning. Plaintiffs’ 3 Lead Counsel and the PSC together form the Plaintiffs’ Leadership Counsel (“PLC”). The 4 PLC assists all Plaintiffs in the MDL by overseeing discovery, appearing in court, attending 5 status conferences, and preparing motions and responses regarding case-wide discovery 6 matters. CMO 1 has been amended to select and appoint a Plaintiffs’ Executive Committee 7 (“PEC”) to assist Lead Counsel in the administration, organization, and strategic decisions 8 of the PLC. Doc. 4016. The configuration of the PSC has changed during the course of 9 the litigation. See Docs. 248, 4016, 5285. 10 CMO 6, entered December 18, 2015, set forth rules, policies, procedures, and 11 guidelines for fees and expenses incurred by attorneys acting for the common benefit of all 12 MDL Plaintiffs. Doc. 372. In May 2019, the Court increased the common benefit 13 attorneys’ fees assessment from 6% to 8%, but declined to increase the 3% assessment for 14 costs. Doc. 18038. 15 Upon transfer, individual Plaintiffs likely will be represented by their own counsel 16 – the attorney or attorneys who filed their original complaint. Plaintiffs’ Lead Counsel, the 17 PSC, the PLC, and the PEC were tasked with managing the MDL for Plaintiffs, not the 18 individual cases upon transfer. 19 E. Status Conferences. 20 Since the inception of the MDL, the Court has held regular status conferences with 21 Lead Counsel for the parties to discuss issues related to the litigation. The initial case 22 management conference was held in October 2015. Doc. 246. Deadlines were set for, 23 among other things, the filing of master and short-form pleadings, profile forms, a proposed 24 protective order (including Rule 502 provisions), a proposed protocol governing the 25 production of electronically stored information (“ESI”), as well as deadlines to complete 26 first-phase MDL discovery and address privilege log issues. Doc. 249. Thereafter, the 27 Court held periodic status conferences to ensure that the parties were on task and to address 28 routine discovery issues and disputes. In addition to the status conferences, the Court -5- 1 conducted telephone hearings to address time-sensitive issues, as well as numerous 2 additional conferences to consider various matters such as dispositive motions and general 3 case management issues. 4 F. 5 Discovery. 1. General Fact Discovery. 6 Prior to the establishment of this MDL, Plaintiffs’ counsel had conducted substantial 7 discovery against Bard concerning all aspects of Bard IVC filters, including the design, 8 testing, manufacturing, marketing, labeling, and post-market surveillance of the devices. 9 Bard produced numerous documents and ESI and responded to thousands of written 10 discovery requests, and more than 80 corporate witness depositions were taken. The 11 pre-MDL fact discovery was made available by Bard to all Plaintiffs in the MDL. 12 CMO 8 established a procedure concerning re-deposing witnesses in the MDL. 13 Doc. 519. CMO 14 established deposition protocols generally. Doc. 2239. The Court 14 allowed additional depositions of a handful of corporate witnesses that had been previously 15 deposed, as well as numerous depositions of other Bard corporate witnesses, including 16 several Rule 30(b)(6) depositions. Docs. 3685, 4311. CMO 9 governed the production of 17 ESI and hard-copy documents. Doc. 1259. 18 Discovery in the MDL was separated into phases. The parties completed the first 19 phase of MDL discovery in early 2016. Doc. 519. The first phase included production of 20 documents related to an FDA inspection and warning letter to Bard, an updated production 21 of complaint and adverse event files, and an updated version of Bard’s complaint database 22 relating to IVC filters. Doc. 249. Plaintiffs also conducted a Rule 30(b)(6) deposition 23 concerning the FDA inspection and warning letter, and a deposition of corporate witness 24 Kay Fuller. 25 The parties completed the second phase of fact discovery in February 2017. CMO 8 26 set deadlines for the second phase, which included all common fact and expert issues in 27 the MDL, but not case-specific issues to be resolved after remand or transfer. Docs. 249, 28 519. Second-phase discovery included extensive additional discovery related to Bard’s -6- 1 system architecture for ESI, Bard’s ESI collection efforts, ESI relating to Bard’s IVC 2 filters, and Bard’s national and regional sales and marketing practices. Plaintiffs also 3 deposed two corporate witnesses in connection with Kay Fuller’s allegations that a 4 submission to the FDA regarding the Recovery filter did not bear her original signature. 5 Doc. 1319 (CMO 10). Plaintiffs deposed additional corporate witnesses concerning the 6 FDA inspections and warning letter. Id. 7 Bard also produced discovery regarding the sales and marketing materials related to 8 the SNF, documents comparing filter performance and failure rates to the SNF, and internal 9 and regulatory communications relating to the SNF. Docs. 1319, 10489. The Court denied 10 Plaintiffs’ request to obtain ESI discovery from Bard’s overseas operations. Doc. 3398. 11 The Court also denied Defendants’ request to discover communications between Plaintiffs’ 12 counsel and NBC news related to stories about the products at issue in this litigation, and 13 third-party financing that may be in place with respect to MDL Plaintiffs. Docs. 3313, 14 3314. Plaintiffs were required to produce communications between Plaintiffs and the FDA 15 related to the FDA warning letter, but the Court denied Defendants’ request to depose 16 Plaintiffs’ counsel regarding these communications. Docs. 3312, 4339. Defendants also 17 produced punitive damages discovery, and Plaintiffs conducted a Rule 30(b)(6) deposition 18 related to Bard’s net worth. 19 All common fact discovery has now been completed, including preservation 20 depositions for certain witnesses who will not be traveling to testify live at the trials of 21 transferred cases. See Docs. 16343, 19959, 21063. Thus, courts receiving these cases need 22 not be concerned with facilitating general fact discovery on remand or transfer. 23 2. Case-Specific Discovery. 24 CMO 5 governed initial case-specific discovery and required the parties to exchange 25 abbreviated profile forms. Doc. 365 (as amended by Doc. 927). Plaintiffs were required 26 to provide Defendants with a Plaintiff profile form (“PPF”) that described individual 27 conditions and claims. 28 Defendants were required to provide the individual Plaintiff with a Defendants’ profile Id. at 5-9. Upon receipt of a substantially complete PPF, -7- 1 form (“DPF”) that disclosed information and documents concerning Defendants’ contacts 2 and relationship with Plaintiff’s physicians, tracking and reporting of Plaintiff’s claims, 3 and certain manufacturing related information for Plaintiff’s filter. Id. at 12-14. Completed 4 profile forms were considered interrogatory answers under Rule 33 or responses to requests 5 for production under Rule 34, and were governed by the standards applicable to written 6 discovery under Rules 26 through 37. Id. at 2-3. CMO 5 also set deadlines and procedures 7 for resolving any purported deficiencies with the parties’ profile forms, and for dismissal 8 of cases that did not provide substantially completed profile forms. Id. at 2.2 9 Further discovery was conducted in a group of 48 cases (“Group 1”) selected for 10 consideration in the bellwether trial process from the pool of cases filed and properly 11 served on Defendants in the MDL as of April 1, 2016 (“Initial Plaintiff Pool”). Docs. 1662, 12 3214, 4311 (CMOs 11, 15, 19). Plaintiffs in Group 1 were required to provide Defendants 13 with a Plaintiff fact sheet (“PFS”) that described their individual conditions and claims in 14 greater detail, and provided detailed disclosures concerning their individual background, 15 medical history, insurance, fact witnesses, prior claims, and relevant documents and 16 records authorizations. Docs. 1153-1, 1662 at 3. 17 Upon receipt of a PFS, Defendants were required to provide the individual Plaintiff 18 with a Defendants fact sheet (“DFS”) that disclosed in greater detail information 19 concerning Defendants’ contacts and relationship with Plaintiff, Plaintiff’s physicians, or 20 anyone on behalf of Plaintiff, Defendants’ tracking and reporting of Plaintiff’s claims, sales 21 and marketing information for the implanting facility, manufacturing information for 22 Plaintiff’s filter, and other relevant documents. Docs. 1153-2, 1662 at 3. Completed fact 23 sheets were considered interrogatory answers under Rule 33 or responses to requests for 24 production under Rule 34, and were governed by the standards applicable to written 25 discovery under Rules 26 through 37. Doc. 1662 at 3. CMO 11 set deadlines and 26 procedures for resolving any purported deficiencies with the parties’ fact sheets. Id. at 2, 27 28 2 The Court has dismissed certain cases where Plaintiffs failed to provide complete PPFs. See Docs. 19874, 20667, 21579. -8- 1 4-5. CMO 12 governed records discovery for Group 1. Doc. 1663. The parties agreed to 2 use The Marker Group to collect medical, insurance, Medicare, Medicaid, prescription, 3 Social Security, workers’ compensation, and employment records for individual plaintiffs 4 from third-parties designated as custodians for such records in the PFS. Id. at 1. 5 From Group 1, twelve cases were selected for further consideration as bellwether 6 cases (“Discovery Group 1”). Docs. 1662, 3685, 4311 (CMOs 11, 18, 19). CMO 20 set 7 deadlines for preliminary case-specific discovery in that group. Doc. 4335. Pursuant to 8 the protocols set in CMOs 14 and 21, the parties were permitted to depose each Plaintiff, 9 his or her spouse or a significant family member, the implanting physician, an additional 10 treating physician, and either a Bard sales representative or supervisor. Docs. 2239, 4866 11 at 1-2. From Discovery Group 1, six Plaintiffs were selected for potential bellwether trials 12 and further case-specific discovery (“Bellwether Group 1”). Docs. 1662, 3685, 4311, 13 5770, 11659 (CMOs 11, 18, 19, 23, and 34). 14 Except for the 48 cases in Group 1, the parties did not conduct case-specific fact 15 discovery for the cases listed on Schedule A during the MDL proceedings, other than 16 exchanging abbreviated profile forms. The Court concluded that any additional case- 17 specific discovery in these cases should await their transfer. Thus, courts receiving these 18 cases should set a schedule for the completion of case-specific discovery. 19 3. Expert Discovery. 20 CMO 8 governed expert disclosures and discovery. Doc. 519. The parties 21 designated general experts in all MDL cases and case-specific experts in individual 22 bellwether cases. General expert discovery closed July 14, 2017. Doc. 3685 (CMO 18). 23 The parties did not conduct case-specific expert discovery for the cases listed on Schedule 24 A during the MDL proceedings. The Court concluded that case-specific expert discovery 25 in these cases should await their transfer. Thus, courts receiving these cases should set a 26 schedule for the completion of case-specific expert discovery. 27 /// 28 /// -9- 1 4. Privileged Materials. 2 CMO 2 required Defendants to produce privilege logs in compliance with the 3 Federal Rules of Civil Procedure. Doc. 249. The parties were then required to engage in 4 an informal privilege log meet and confer process to resolve any privilege disputes. 5 Defendants produced several privilege logs identifying documents withheld pursuant to the 6 attorney-client privilege, the work-product doctrine, and other privileges. The parties 7 regularly met and conferred regarding the privilege logs and engaged in negotiations 8 regarding certain entries identified by Plaintiffs. As part of that meet and confer process, 9 Defendants provided Plaintiffs with a small number of these identified items for inspection 10 and, in some cases, withdrew certain claims of attorney-client privilege and produced the 11 previously withheld items. 12 CMO 3 governed the non-waiver of any privilege or work-product protection in this 13 MDL, pursuant to Federal Rule of Evidence 502(d), by Defendants’ disclosure or 14 production of documents on its privilege logs as part of the meet and confer process. Doc. 15 314. 16 In late 2015, Plaintiffs challenged a substantial number of documents on 17 Defendants’ privilege log. The parties engaged in an extensive meet and confer process, 18 and Defendants produced certain documents pursuant to the Rule 502(d) order. See id. 19 Plaintiffs moved to compel production of 133 disputed documents. The Court granted the 20 motion in part. Doc. 2813. The parties identified several categories of disputed documents 21 and provided sample documents for in camera review. The Court denied Plaintiffs’ motion 22 with respect to seven of eight categories of documents and found only one of the sample 23 documents in one of the categories to contain unprivileged portions that should be 24 produced. The Court found all other documents protected by the attorney-client privilege 25 or work product doctrine. The Court directed the parties to use this ruling as a guide to 26 resolve remaining privilege disputes. 27 Since this ruling, there have been no further challenges to Defendants’ privilege 28 logs. Defendants continued to provide updated privilege logs throughout the discovery - 10 - 1 process, and the parties met and conferred to resolve privilege disputes. Privilege issues 2 should not be a concern for courts that receive these cases. 3 5. Protective Order and Confidentiality. 4 A stipulated protective order governing the designation, handling, use, and 5 disclosure of confidential discovery materials was entered in November 2015. Doc. 269. 6 CMO 7, entered January 5, 2016, governed redactions of material from additional adverse 7 event reports, complaint files, and related documents in accordance with the Health 8 Insurance Portability Act of 1996 (“HIPAA”) and under 21 C.F.R. § 20.63(f). Doc. 401. 9 In September 2016, to expedite production of ESI, the parties agreed to a primarily 10 “no-eyes-on” document production as to relevancy while still performing a privilege 11 review for this expedited ESI document production. CMO 17 (Doc. 3372) modified the 12 protections and requirements in the stipulated protective order (Doc. 269) and CMO 7 13 (Doc. 401) for ESI produced pursuant to this process. CMO 17 was amended in November 14 2016. Doc. 4015. 15 Defendants filed a motion to seal certain trial exhibits at the conclusion of the first 16 bellwether trial. Doc. 11010. The Court denied this motion and Defendants’ subsequent 17 motion for reconsideration. Docs. 11642, 11766, 12069. Defendants also filed a motion 18 to enforce the protective order for the second and third bellwether trials collectively. Doc. 19 13126. This motion was denied. Doc. 14446. A list of exhibits admitted at the bellwether 20 trials (excluding case-specific medical records) and documents deemed no longer subject 21 to the protective order are attached as Exhibit 2. 22 G. 23 Six Plaintiffs were selected for potential bellwether trials. Docs. 5770, 11659 24 (CMOs 23, 34). The Court held three bellwether trials: Booker, No. 2:16-cv-00474, Jones, 25 No. 2:16-cv-00782, and Hyde, No. 2:16-cv-00893. The Court granted summary judgment 26 in one of the bellwether cases, Kruse, No. 2:15-cv-01634, and removed another from the 27 bellwether trial schedule at the request of Plaintiffs, Mulkey, No. 2:16-cv-00853. Docs. 28 12202, 13329. The final bellwether case, Tinlin, No. 2:16-cv-00263, settled shortly before Bellwether Cases and Trials. - 11 - 1 trial in May 2019. The Court determined that further bellwether trials were not necessary. 2 Docs. 12853, 13329 (CMOs 38, 40). 3 1. Booker, No. 2:16-cv-00474. 4 The first bellwether trial concerned Plaintiff Sherr-Una Booker and involved a Bard 5 G2 filter. The filter had tilted, migrated, and fractured. Plaintiff required open heart 6 surgery to remove the fractured limbs and repair heart damage caused by a percutaneous 7 removal attempt. Plaintiff withdrew her breach of warranty claims before Defendants 8 moved for summary judgment. The Court granted Defendants’ motion for summary 9 judgment on the claims for manufacturing defects, failure to recall, misrepresentation, 10 negligence per se, and breach of warranty. Docs. 8873, 8874. The remaining claims for 11 failure to warn, design defect, and punitive damages were tried to a jury over a three-week 12 period in March 2018. 13 The jury found for Plaintiff Booker on her negligent failure-to-warn claim, and in 14 favor of Defendants on the design defect and strict liability failure-to-warn claims. 15 Doc. 10595. The jury returned a verdict of $2 million in compensatory damages (of which 16 $1.6 million was attributed to Defendants after apportionment of fault) and $2 million in 17 punitive damages. Id.; Doc. 10596. The Court denied Defendants’ motions for judgment 18 as a matter of law and a new-trial. Docs. 10879, 11598. 19 Defendants appealed, arguing that the Court erred by denying summary judgment 20 on their preemption defense, that a failure-to-warn claim was unavailable, and that the 21 award of punitive damages was not supported by the evidence. See Docs. 11934, 11953. 22 The Ninth Circuit affirmed. See In re Bard IVC Filters Prods. Liab. Litig., No. 18-16349 23 (Doc. 77), 2020 WL 4692349 (9th Cir. Aug. 13, 2020). Defendants’ petition for panel 24 rehearing and rehearing en banc is pending. See No. 18-16349, Doc. 78.3 25 26 /// /// 27 28 3 17916. Plaintiff filed and later dismissed with prejudice a cross-appeal. Docs. 12070, - 12 - 1 2. Jones, No. 2:16-cv-00782. 2 The second bellwether trial concerned Plaintiff Doris Jones and involved a Bard 3 Eclipse filter. Plaintiffs withdrew the manufacturing defect, failure to recall, and breach of 4 warranty claims. 5 negligence per se, and unfair trade practices claims. Doc. 10404. The remaining claims 6 for failure to warn, design defect, and punitive damages were tried to a jury over a 7 three-week period in May 2018. The jury returned a defense verdict. Doc. 11350. Plaintiff 8 filed a motion to contact the jurors, which was denied. Docs. 11663, 12068. The Court granted summary judgment on the misrepresentation, 9 Plaintiff appealed the Court’s rulings excluding cephalad migration death evidence. 10 Docs. 12057, 12071. The Ninth Circuit affirmed those rulings. See In re Bard IVC Filters 11 Prods. Liab. Litig., No. 18-16461 (Doc. 51), 2020 WL 4719266, at *1 (9th Cir. Aug. 13, 12 2020). Plaintiff’s petition for rehearing en banc is pending. See No. 18-16461, Doc. 53. 13 14 15 16 3. Kruse, No. 2:15-cv-01634. Plaintiff Carol Kruse’s case was set for trial in September 2018. The Court granted Defendants’ summary judgment motion on statute of limitations grounds. Doc. 12202. 4. Hyde, No. 2:16-cv-00893. 17 The third bellwether trial concerned Plaintiff Lisa Hyde and involved either a Bard 18 G2X or Eclipse filter (the exact model was in dispute). Ms. Hyde’s case was moved to the 19 September 2018 bellwether slot in lieu of Ms. Kruse’s case. Doc. 11867. Plaintiffs 20 withdrew their claims for manufacturing defect and breach of express warranty. The Court 21 granted summary judgment on the claims for breach of implied warranty, failure to warn, 22 failure to recall, misrepresentation, concealment, and fraud. Doc. 12007. The Court also 23 entered judgment in favor of Defendants on the negligence per se claim after concluding 24 that it was impliedly preempted under 21 U.S.C. § 337(a). Doc. 12589. The remaining 25 claims for design defect, loss of consortium, and punitive damages were tried to a jury over 26 three weeks in September 2018. After the close of Plaintiffs’ evidence, the Court granted 27 in part Defendants’ motion for judgment as a matter of law with respect to future damages 28 for any cardiac arrhythmia Ms. Hyde may experience, but denied the motion as to the - 13 - 1 remaining claims. Doc. 12805. The jury returned a defense verdict. Doc. 12891. Plaintiff 2 has appealed. Docs. 13465, 13480. 3 5. Mulkey, No. 2:16-cv-00853. 4 Plaintiff Debra Mulkey’s case involved an Eclipse filter and was set for trial in 5 February 2019. Before trial, Plaintiffs asked the Court to remove the Mulkey case from 6 the bellwether trial schedule because it was similar to the Jones and Hyde cases and would 7 not provide meaningful information to the parties. Doc. 12990. The Court granted the 8 motion. Doc. 13329. 9 6. Tinlin, No. 2:16-cv-00263. 10 The final bellwether trial concerned Plaintiff Debra Tinlin and involved a Bard 11 Recovery filter. Plaintiffs withdrew their claims for manufacturing defect, failure to recall, 12 negligence per se, and breach of warranty. The Court granted summary judgment on the 13 misrepresentation and deceptive trade practices claims. Doc. 17008. The remaining claims 14 for failure to warn, design defect, concealment, loss of consortium, and punitive damages 15 were scheduled for trial in May 2019, but the case settled. 16 H. 17 The Court has made many rulings in this MDL that could affect the remanded and 18 transferred cases. The Court provides the following summary of key legal and evidentiary 19 rulings to assist the courts that receive these cases. 20 Key Legal and Evidentiary Rulings. 1. Medical Monitoring Class Action Ruling. 21 In May 2016, Plaintiffs’ counsel filed a medical monitoring class action that was 22 consolidated with the MDL. See Barraza v. C. R. Bard, Inc., No. 2:16-cv-01374 (D. Ariz. 23 May 5, 2015). The Barraza Plaintiffs moved for class certification for medical monitoring 24 relief on behalf of themselves and classes of individuals who have been implanted with a 25 Bard IVC filter, have not had that filter removed, and have not filed a claim or lawsuit for 26 personal injury related to the filter. Id., Doc. 54. The Court declined to certify the class. 27 Id., Doc. 95. 28 - 14 - 1 The class certification motion recognized that only 16 states permit claims for 2 medical monitoring. The Court concluded that the classes could not be certified under Rule 3 23(b)(3) because individual issues would predominate. Id. at 20-21. The Court further 4 concluded that the class could not be certified under Rule 23(b)(2) because the medical 5 monitoring relief primarily constituted monetary rather than injunctive relief, and the class 6 claims were not sufficiently cohesive to permit binding class-wide relief. Id. at 21-32. 7 Finally, the Court concluded that typicality under Rule 23(a)(3) had not been established. 8 Id. at 32-34. The Barazza Plaintiffs dismissed their claims without prejudice. Docs. 106, 9 107. No appeal has been filed. 10 2. Federal Preemption Ruling. 11 Defendants moved for summary judgment on the grounds that Plaintiffs’ state law 12 claims are expressly preempted by the Medical Device Amendments of 1976 (“MDA”), 13 21 U.S.C. § 360 et seq., and impliedly preempted by the MDA under the Supreme Court’s 14 conflict preemption principles. Doc. 5396. The Court denied the motion. Doc. 8872. 15 The MDA curtails state regulation of medical devices through a provision that 16 preempts state requirements that differ from or add to federal requirements. 21 U.S.C. 17 § 360k. The Bard IVC filters at issue in this litigation were cleared for market by the FDA 18 through section “510k” review, which focuses primarily on equivalence rather than safety 19 and effectiveness. See § 360c(f)(1)(A). 20 The Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), held that 21 § 360k does not preempt state law claims directed at medical devices cleared through 22 the 510(k) process because substantial equivalence review places no federal requirements 23 on a device. Id. at 492-94. Lohr also noted that the “510(k) process is focused on 24 equivalence, not safety.” Id. at 493 (emphasis in original). Although the Safe Medical 25 Devices Act of 1990 (“SMDA”), Pub. L. 101-629, injected safety and effectiveness 26 considerations into 510(k) review, it did so only comparatively. The Court found that Lohr 27 remains good law and that clearance of a product under 510(k) generally does not preempt 28 state common law claims. Doc. 8872 at 12-14. - 15 - 1 The Court further found that Defendants failed to show that the 510(k) reviews for 2 Bard IVC filters imposed device-specific requirements as needed for preemption under 3 § 360k. Id. at 14-20. Even if device-specific federal requirements could be ascertained, 4 Defendants made no showing that any particular state law claim is expressly preempted by 5 federal requirements. Id. at 21-22. 6 The Court concluded that Plaintiffs’ state law claims are not impliedly preempted 7 because Defendants failed to show that it is impossible to do under federal law what the 8 state laws require. Id. at 22-24. 9 Defendants pursued their preemption arguments in the Booker appeal. See Docs. 10 11934, 11953. As noted, the Ninth Circuit affirmed the Court’s preemption ruling. See In 11 re Bard IVC Filters Prods. Liab. Litig., No. 18-16349, 2020 WL 4692349, at *1-6 (9th Cir. 12 Aug. 13, 2020). 13 3. The Lehmann Report Privilege and Work Product Rulings. 14 The Court granted Defendants’ motion for a protective order to prevent Plaintiffs 15 from using a December 15, 2004 report of Dr. John Lehmann. Doc. 699. Dr. Lehmann 16 provided various consulting services to Bard at different times. Following Bard’s receipt 17 of potential product liability claims involving the Recovery filter, Bard’s legal department 18 retained Dr. Lehmann in November 2004 to provide an assessment of the risks associated 19 with the Recovery filter and the extent of Bard’s legal exposure. Dr. Lehmann prepared a 20 written report of his findings at the request of the legal department and in anticipation of 21 litigation. The Court found the report to be protected from disclosure by the work product 22 doctrine. Id. at 4-12. The Court further found that Plaintiffs had not shown a substantial 23 need for the report or undue hardship if the report was not disclosed. Id. at 13-15. The 24 Court agreed with the parties that this ruling does not alter any prior rulings by transferor 25 judges in specific cases. Id. at 22. 26 27 28 4. Daubert Rulings. The Court has ruled on Daubert motions directed at general experts, and refers the remand and transfer courts to the following orders: - 16 - 1 2 3 Daubert Order Doc. Nos. Plaintiffs’ Expert Dr. Thomas Kinney 9428, 10323 4 5 Plaintiffs’ Experts Drs. Scott Resnick, Robert Vogelzang, 9432 Kush Desai, and Robert Lewandowski 6 7 Plaintiffs’ Experts Drs. David Kessler and Suzanne 9433 Parisian 8 9 Plaintiffs’ Experts Drs. Thomas Kinney, Anne Christine 9434 Roberts, and Sanjeeva Kalva 10 11 Plaintiffs’ Expert Dr. Mark Eisenberg 9770 Plaintiffs’ Expert Dr. Derek Muehrcke 9771 Plaintiffs’ Expert Dr. Darren Hurst 9772 16 Plaintiffs’ Expert Dr. Rebecca Betensky 9773 17 Defendants’ Expert Dr. Clement Grassi 9991, 10230 Plaintiffs’ Expert Dr. Robert McMeeking 10051, 16992 Plaintiffs’ Expert Dr. Robert Ritchie 10052 Plaintiffs’ Experts Drs. David Garcia and Michael Streiff 10072 Defendants’ Expert Dr. Christopher Morris 10230, 10231, 17285 12 13 14 15 18 19 20 21 22 23 24 25 26 27 28 - 17 - 1 5. 2 Motion in Limine Rulings. a. FDA Evidence (Cisson Motion). 3 In the Booker bellwether trial, Plaintiffs sought to exclude, under Federal Rules of 4 Evidence 402 and 403, evidence of the FDA’s 510(k) clearance of Bard IVC filters and the 5 lack of FDA enforcement action against Bard. Doc. 9529. The Court denied the motion. 6 Docs. 9881, 10323. 7 The Court found that under Georgia law, which applied in both the Booker and 8 Jones bellwether cases, compliance with federal regulations may not render a 9 manufacturer’s design choice immune from liability, but evidence of Bard’s compliance 10 with the 510(k) process was nonetheless relevant to the design defect and punitive damages 11 claims. Doc. 9881 at 3-4. The Court acknowledged concerns that FDA evidence might 12 mislead the jury or result in a mini-trial. Id. at 5-6 (citing In re C.R. Bard, Inc., Pelvic 13 Repair Sys. Prods. Liab. Litig. (Cisson), No. 2:10-CV-01224, 2013 WL 3282926, at *2 14 (S.D.W. Va. June 27, 2013)). But the Court concluded that such concerns could adequately 15 be addressed by efficient management of the evidence and adherence to the Court’s time 16 limits for trial, and, if necessary, by a limiting instruction regarding the nature of the 510(k) 17 process. Id. at 6-7.4 18 The Court noted that the absence of any evidence regarding the 510(k) process 19 would run the risk of confusing the jury, as many of the relevant events in this litigation 20 occurred in the context of the FDA’s 510(k) review of the Bard filters and are best 21 understood in that context. Doc. 9881 at 7. Nor was the Court convinced that all FDA 22 references could adequately be removed from the evidence. Id. 23 The Court further concluded that it would not exclude evidence and arguments by 24 Defendants that the FDA took no enforcement action against Bard with respect to the G2 25 or Eclipse filters, or evidence regarding information Bard provided to the FDA in 26 connection with the 510(k) process. Docs. 10323 at 2-3 (Booker), 11011 at 4-5 (Jones). 27 28 4 The Court did not find a limiting instruction necessary at the close of either the Booker or Jones trials. See Doc. 10694 at 9. - 18 - 1 The Court found that the evidence was relevant to the negligent design and punitive 2 damages claims under Georgia law. Id. The Court determined at trial that it had no basis 3 to conclude that the FDA’s lack of enforcement was intended by the FDA as an assertion, 4 and therefore declined to exclude the evidence as hearsay. Doc. 10568 at 87. 5 b. FDA Warning Letter. 6 Defendants moved to exclude evidence of the July 13, 2015 FDA warning letter 7 issued to Bard. Doc. 9864 at 2-3. The Court granted the motion in part, excluding as 8 irrelevant topics 1, 2, 4(a), 4(b), 5, 6, 7, and 8 of the warning letter. Docs. 10258 at 6-8 9 (Booker), 10805 at 1 (Jones), 12736 (Hyde), 17401 at 10 (Tinlin). Topics 1 and 2 concern 10 the Recovery Cone retrieval system; Topic 4(a) concerns the filter cleaning process; and 11 Topics 4(b), 5, 6, 7, and 8 concern the Denali Filter. The Court concluded that none of 12 these topics was relevant to the issues in the bellwether cases involving a G2 filter 13 (Booker), an Eclipse filter (Jones), either a G2X or Eclipse filter (Hyde), and a Recovery 14 filter (Tinlin). Id. 15 The Court deferred ruling on the relevance of topic 3 until trial in all bellwether 16 cases. The Court found that topic 3, concerning Bard’s complaint handling and reporting 17 of adverse events with respect to the G2 and Eclipse filters, as well as the adequacy of 18 Bard’s evaluation of the root cause of the violations, was relevant to rebut the implication 19 at trial that the FDA took no action with respect to Bard IVC filters. See Doc. 10693 at 13- 20 15; Doc. 11256. The Court concluded that the warning letter was admissible under Federal 21 Rule of Evidence 803(8), and was not barred as hearsay. Doc. 10258 at 7. The Court 22 further concluded that the probative value of topic 3 was not substantially outweighed by 23 the danger of unfair prejudice to Bard under Rule 403. Id. The Court admitted the warning 24 letter in redacted form during the three bellwether trials. See Docs. 10565, 11256, 12736. 25 The Court noted that topic 3 included reference to the G2, the filter at issue in Booker, and 26 reached similar conclusions in Jones and Hyde. Doc. 17401 at 11. The parties disputed 27 the relevance of topic 3 in Tinlin because it did not include reference to the Recovery, the 28 - 19 - 1 filter at issue in Tinlin. Id. The Court did not decide this issue because the Tinlin case 2 settled. 3 c. Recovery Cephalad Migration Death Evidence. 4 Defendants moved to exclude evidence of cephalad migration (i.e., migration of the 5 filter toward the patient’s heart) by a Recovery filter resulting in patient death. The Court 6 denied the motion for the Booker bellwether trial, which involved a G2 filter. Docs. 10258 7 at 4-5, 10323 at 4. 8 The Court granted the motion for the Jones bellwether trial, which involved an 9 Eclipse filter, and denied Plaintiff’s requests for reconsideration of the ruling before and 10 during the trial. 11 Doc. 11409 at 94-96. As noted, the Ninth Circuit affirmed the Court’s rulings. See In re 12 Bard IVC Filters Prods. Liab. Litig., No. 18-16461, 2020 WL 4719266, at *1 (9th Cir. 13 Aug. 13, 2020). Plaintiff’s petition for rehearing en banc is pending. See No. 18-16461, 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 See Docs. 10819, 10920, 11041, 11113, 11256, 11302; see also Doc. 53. The Court granted the motion for the Hyde bellwether trial, which involved either a G2X or Eclipse filter. Doc. 12533 at 6-7. Plaintiff Hyde has appealed this ruling. Docs. 13465, 13480. The Court denied Defendants’ motion for the Tinlin bellwether trial, which involved a Recovery filter. Doc. 17401 at 7-10. The Tinlin case settled before trial. The Court concluded for purposes of the Booker bellwether trial that evidence of cephalad migrations by a Recovery filter resulting in patient death was necessary for the jury to understand the issues that prompted creation and design of the next-generation G2 filter, and thus was relevant to Plaintiff’s design defect claims. Doc. 10323 at 4. In addition, because the Recovery filter was the predicate device for the G2 filter in Defendants’ 510(k) submission to the FDA, and Defendants asserted to the FDA that the G2 was as safe and effective as the Recovery, the Court concluded that the safety and effectiveness of the Recovery filter was at issue. Id. The Court was concerned, however, that too heavy an emphasis on deaths caused by cephalad migration of the Recovery filter – - 20 - 1 a kind of migration which did not occur in the G2 filter generally or the Booker case 2 specifically – would result in unfair prejudice to Defendants that substantially outweighed 3 the probative value of the evidence. Id. Defendants did not object during trial that 4 Plaintiffs were over-emphasizing the death evidence. 5 The Court initially concluded for purposes of the Jones bellwether trial, which 6 involved an Eclipse filter, that evidence of cephalad migration deaths by the Recovery filter 7 was inadmissible because it was only marginally relevant to Plaintiff’s claims and its 8 marginal relevancy was substantially outweighed by the risk of unfair prejudice. See Docs. 9 10819, 10920, 11041, 11113, 11256, 11302. This is because cephalad migration did not 10 continue in any significant degree beyond the Recovery filter; cephalad migration deaths 11 all occurred before the Recovery was taken off the market in late 2005; Ms. Jones did not 12 receive her Eclipse filter until 2010; the Recovery-related deaths said nothing about three 13 of Ms. Jones’ four claims (strict liability design defect and the failure to warn claims); and 14 instances of cephalad migration deaths were not substantially similar to complications 15 experienced by Ms. Jones and therefore did not meet the Georgia standard for evidence on 16 punitive damages. Docs. 10819, 11041. 17 The Court also found that deaths caused by a non-predicate device (the Recovery 18 was not the predicate device for the Eclipse in Defendants’ 510(k) submission), and by a 19 form of migration that was eliminated years earlier, were of sufficiently limited probative 20 value that their relevancy was substantially outweighed by the danger of unfair prejudice 21 because the death evidence may prompt a jury decision based on emotion. Id. The Court 22 further concluded that Plaintiff Jones would not be seriously hampered in her ability to 23 prove Recovery filter complications, testing, and design when references to cephalad 24 migration deaths are removed. Doc. 11041. As a result, the Court held that such references 25 should be redacted from evidence presented during the Jones trial. 26 The Court balanced this concern with the competing concern that it would be unfair 27 for Defendants to present statistics about the Recovery filter and not allow Plaintiffs to 28 present competing evidence that included Recovery deaths. See, e.g., Doc. 11391 at 12. - 21 - 1 Based on this concern, Plaintiffs argued at various points during the trial that Defendants 2 had opened the door to presenting evidence about Recovery cephalad migration deaths. 3 The Court repeatedly made fact-specific determinations on this point, holding that even 4 though Defendants presented some evidence that made the Recovery evidence more 5 relevant, the danger of unfair prejudice continued to substantially outweigh the probative 6 value of the cephalad migration death evidence. See Docs. 11113, 11302; see also Doc. 7 11409 at 94-96. 8 The Court concluded for purposes of the Hyde bellwether trial, which involved 9 either a G2X or Eclipse filter, that evidence of Recovery filter cephalad migration deaths 10 should be excluded under Rule 403 for the reasons identified in the Jones bellwether trial. 11 Doc. 12533 at 6-7. The Court concluded that this evidence had marginal relevance to 12 Plaintiff’s claims because Ms. Hyde received either a G2X or Eclipse filter, two or three 13 generations after the Recovery filter; Ms. Hyde did not receive her filter until 2011, more 14 than five years after cephalad migration deaths stopped when the Recovery was taken off 15 the market; the deaths did not show that G2X or Eclipse filters – which did not cause 16 cephalad migration deaths – had design defects when they left Defendants’ control; nor did 17 the cephalad migration deaths, which were eliminated by design changes in the G2, shed 18 light on Defendants’ state of mind when designing and marketing the G2X and Eclipse 19 filters. Id. at 7. 20 The Court concluded for purposes of the Tinlin bellwether trial, which involved a 21 Recovery filter, that Recovery deaths and Defendants’ knowledge of those deaths were 22 relevant to Plaintiffs’ design defect claim under Wisconsin law because they went directly 23 to the Recovery’s foreseeable risks of harm and whether it was unreasonably dangerous. 24 Doc. 17401 at 7-8. The Court also concluded that the Recovery death evidence was 25 relevant to Plaintiffs’ failure to warn and concealment claims because it was probative on 26 the causation issue – that is, whether her treating physician would have selected a different 27 filter for Ms. Tinlin had he been warned about the Recovery’s true risks, as Plaintiffs 28 describe them. Id. at 8. In addition, because this evidence would be used to impeach expert - 22 - 1 testimony from Defendants that the Recovery filter was safe and effective, the Court 2 concluded that substantial similarity was not required. Id. at 8-9. The Court further 3 concluded that the death evidence was relevant to Bard’s state of mind and to show the 4 reprehensibility of its alleged conduct for purposes of punitive damages. Id. at 9-10. The 5 Court reached a different conclusion in the Jones and Hyde cases because cephalad 6 migration deaths stopped when the Recovery was taken off the market in 2005, and the 7 deaths shed little light on Defendants’ state of mind when marketing different, improved 8 filters years later. Id. at 9 n.4. As noted, the Tinlin case settled before trial. 9 d. SNF Evidence. 10 Plaintiffs sought to exclude evidence of complications associated with the SNF, 11 claiming that they were barred from conducting relevant discovery into the design and 12 testing of the SNF under CMO 10. Doc. 10487; see Doc. 1319. The Court denied 13 Plaintiffs’ request. Doc. 10489. The Court did not agree that Plaintiffs were foreclosed 14 from obtaining relevant evidence for rebuttal. The Court foreclosed this discovery because 15 Plaintiffs did not contend that the SNF was defective. Id. at 2. Plaintiffs also had rebuttal 16 evidence showing that reported failure rates for SNF were lower than Recovery and G2 17 failure rates. Id. The Court ultimately concluded it would not preclude Defendants from 18 presenting its SNF evidence on the basis of a discovery ruling and permitted Plaintiffs to 19 make appropriate evidentiary objections at trial. Id. at 3. 20 e. Use of Testimony of Withdrawn Experts. 21 Defendants sought to preclude Plaintiffs’ use at trial of the depositions of three 22 defense experts – Drs. Moritz, Rogers, and Stein – who originally were retained by Bard 23 but were later withdrawn in some or all cases. Doc. 10255 at 2. The Court denied the 24 request in part. Doc. 10382. The Court found that Defendants failed to show that the 25 depositions of these experts were inadmissible on hearsay grounds, but agreed that it would 26 be unfairly prejudicial under Rule 403 to disclose to the jury that the experts originally 27 were retained by Bard. Id. at 2-3. The Court therefore concluded that Plaintiffs could use 28 portions of the experts’ depositions that support Plaintiffs’ claims, but could not disclose - 23 - 1 to the jury that the experts originally were retained by Bard. Id. at 3. The Court was 2 concerned about the presentation of cumulative evidence, and therefore required Plaintiffs 3 to show that no other expert of similar qualifications was available or that the unavailable 4 expert had some unique testimony to contribute, before the deposition of any withdrawn 5 expert could be used at trial. Id. at 3-4. 6 f. Other Motion in Limine Rulings. 7 Other motion in limine (“MIL”) rulings may be useful to the receiving courts. See 8 Docs. 10075, 10235, 10258, 10947. The courts are referred to the following motions and 9 orders to assist in preparing for trial:5 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 • Parties’ Joint Stipulation on MILs in Booker: The Court, on stipulation of the parties, excluded evidence concerning several case-specific issues in the Booker bellwether trial, as well as a few general issues, including: Bard’s 1994 criminal conviction; other lawsuits or claims against Bard; advertising by Plaintiff’s counsel; Plaintiff’s counsel specializing in personal injury or products liability litigation; contingency fee agreements; and advertising by any counsel nationally for IVC filter cases. Doc. 10235. • Defendants MIL 1 in Booker: The Court permitted evidence and testimony concerning Recovery complications. Doc. 10258 at 1-5; see Doc. 10819 (Jones). As noted above, the Court permitted evidence and testimony concerning Recovery filter cephalad migration deaths in the Booker bellwether trial involving a G2 filter (Doc. 10323 at 4), but excluded such evidence in the trials involving a G2X or Eclipse filter (Docs. 10819, 10920, 11041). • Defendants’ MIL 2 in Booker: The Court permitted evidence and testimony relating to the development of the Recovery filter. Doc. 10258 at 5-6; see Doc. 10819 at 2-3 (Jones). • Defendants’ MIL 4 in Booker: The Court excluded evidence and testimony concerning a photograph of Bard employee Michael Randall making an offensive gesture. Doc. 10075 at 1-2. • Defendants’ MIL 5 in Booker: The Court permitted Plaintiff’s expert Dr. Thomas Kinney to be called as a fact witness, but prohibited him from testifying regarding his prior work for Bard as an expert witness in two prior IVC filter cases or as a paid consultant to Bard. Docs. 10075 at 2-3, 10323 at 4. 25 26 The Court also ruled on the parties’ MILs concerning several case-specific issues. See Docs. 10075 (Plaintiff’s MIL 12 in Booker), 10258 (Plaintiff’s’ MILs 6 and 13 in Booker), 10947 (Defendants’ MIL 1 and Plaintiff’s MILs 1-4 and 7 in Jones), 12533 (Plaintiff’s MIL 3 in Hyde), 17285 (Plaintiff’s MIL 1 in Tinlin), 17401 (Plaintiff’s MILs 2, 3, and 6 in Tinlin). 5 27 28 - 24 - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 • Plaintiff’s MIL 2 in Booker: The Court reserved ruling until trial on evidence and testimony regarding the nature of Bard’s business, including the nature, quality, and usefulness of its products, the conscientiousness of its employees, and references to its mission statement. Doc. 10075 at 3-4. • Plaintiff’s MIL 3 in Booker: The Court permitted evidence and testimony concerning the benefits of IVC filters, including testimony describing Bard filters as “lifesaving” devices. Doc. 10258 at 8. • Plaintiff’s MIL 4 in Booker: The Court permitted evidence and testimony that IVC filters, including Bard’s filters, are within the standard of care for the medical treatment of pulmonary embolism. Doc. 10258 at 8-9. Defendants agreed to not characterize IVC filters as the “gold standard” for the treatment of pulmonary embolisms. Id. at 8. • Plaintiff’s MIL 5 in Booker: The Court denied as moot the motion to exclude evidence and argument relating to failure rates, complication rates, percentages, or comparative analysis of any injuries that were not produced to Plaintiffs during discovery, as all such information was produced. Doc. 10075 at 4. • Plaintiff’s MIL 7 in Booker: The Court excluded evidence and argument relating to prior judicial opinions about Plaintiffs’ experts, including the number of times their testimony has been precluded in other cases. Id. • Plaintiff’s MIL 8 in Booker: The Court excluded evidence and argument that a verdict against Defendants will have an adverse impact on the medical community, future medical device research or costs, and the availability of medical care. Id. at 4-5. • Plaintiff’s MIL 9 in Booker: The Court deferred ruling on the relevance of statements or lack of statements from medical societies, including the Society of Interventional Radiologists (“SIR”), until trial. Doc. 10258 at 14-18. The Court ultimately admitted this evidence in both the Booker and Jones bellwether trials. • Plaintiff’s MIL 10 in Booker: The Court excluded evidence and testimony that Bard needed FDA consent to add warnings to its labels, send warning letters to physicians and patients, or recall its filters. Id. at 18-19. The Court permitted evidence and argument explaining the reasons why Bard filters were not recalled, FDA’s potential involvement in any recall effort, and the fact that warnings about failure rates and increased risks could not be based on MDR and MAUDE data alone. Id. • Plaintiff’s MIL 11 in Booker: The Court permitted evidence and argument relating to the informed consent form signed by Plaintiff prior to insertion of the IVC filter, even though the form is not specific to IVC filters or Bard filters. Doc. 10075 at 5-6. • Plaintiff’s MIL 14 in Booker: The Court reserved ruling until trial on evidence and argument relating to background information and personal traits of Bard employees and witnesses. Id. at 7. • Plaintiff’s MIL 6 in Jones: The Court permitted evidence and testimony concerning whether a party’s expert had been retained by the same attorneys in other litigation. Doc. 10947 at 8-9. - 25 - • Plaintiff’s MIL 5 in Jones: The Court excluded evidence and testimony that Bard employees or their relatives have received Bard IVC filter implants. Id. at 9-10. 1 2 • Defendants’ MIL 2 in Jones: The Court excluded evidence and testimony of other lawsuits against Bard. Id. at 11. 3 4 • Plaintiff’s MILs 4 and 5 in Hyde: The Court permitted evidence and testimony concerning Bard’s Instructions for Use (“IFU”) and SIR Guidelines. Doc. 12507. 5 6 • Plaintiff’s MIL 2 in Hyde: The Court permitted evidence and testimony concerning “The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism.” Doc. 12533 at 4-6. 7 8 • Defendants’ MIL 3 in Hyde: The Court permitted evidence and testimony that Bard’s SNF is a reasonable alternative design. Id. at 7. 9 10 • Defendants’ MIL 4 in Hyde: The Court excluded testimony from Dr. Muehrcke about his personal feelings of betrayal and his moral and ethical issues with Bard’s conduct. Id. at 7-8. 11 12 • Defendants’ MIL 6 in Hyde: The Court permitted evidence and testimony regarding informed consent. Id. at 8-9. 13 • Plaintiff’s MIL 4 in Tinlin: The Court reserved ruling until trial on evidence and argument relating to a chart created by Defendants from their internal TrackWise database regarding reporting rates of IVC filter complications. Doc. 17401 at 5. 14 15 16 • Plaintiff’s MIL 5 in Tinlin: The Court permitted evidence and testimony concerning a chart comparing the sales of the permanent SNF with those of retrievable filters between 2002 and 2016. Id. at 5-6. 17 18 • Defendants’ MIL 3 in Tinlin: The Court permitted evidence and testimony concerning the Recovery Filter Crisis Communications Plan that Bard had prepared in 2004 to help manage damaging media coverage about a Recovery migration death. Id. at 11-12. 19 20 21 • Defendants’ MIL 4 in Tinlin: The Court excluded evidence and testimony concerning Dr. Muehrcke’s untimely disclosed opinion that one of his patients died from cardiac tamponade caused by a fractured strut that had embolized to her heart. Id. at 12-13. 22 23 24 /// 25 /// 26 /// 27 /// 28 /// - 26 - 1 2 3 6. Deposition Designation Rulings. The Court has ruled on numerous objections to deposition designations for trial and refers the transferor courts to the following orders:6 4 5 Deponent Depo. Date Doc. No(s). 6 Bill Altonaga 10/22/2013 10497, 10922 Christine Brauer 05/23/2014 10922, 08/02/2017 10922 David Ciavarella 11/12/2013 10403 Gary Cohen 01/25/2017 10438 12 Robert Cortelezzi 11/11/2016 10438, 11064 13 Len DeCant 05/24/2016 10438, 11080 John DeFord 06/02/2016 10524, 11080 Mary Edwards 01/20/2014 10438 Robert Ferrara 04/17/2017 10438 18 Chris Ganser 10/11/2016 10438, 11073 19 Jason Greer 08/11/2014 10438, 10922 20 Janet Hudnall 11/01/2013 10403 Brian Hudson 01/17/2014 10403 John Lehmann 08/07/2014 10922 24 William Little 07/27/2016 10438, 11064 25 John McDermott 02/05/2014 10438 7 8 9 10 11 14 15 16 17 21 22 23 26 27 28 6 In addition to the depositions identified in the table above, the Court ruled on numerous objections to case-specific deposition designations for trial. - 27 - 1 Deponent Depo. Date Doc. No(s). Patrick McDonald 07/29/2016 10486, 11064 4 Mark Moritz 07/18/2017 10922 5 Daniel Orms 08/16/2016 10403, 11073 6 Abithal Raji-Kubba 07/18/2016 11064 Gin Schulz 01/30/2014 10403 Christopher Smith 08/03/2017 11073 10 William Stavropoulos 02/01/2017 10524 11 Jack Sullivan 11/03/2016 10486, 09/16/2016 11080 2 3 7 8 9 12 13 Melanie Sussman 04/07/2017 11073 14 Mehdi Syed 03/02/2018 11313 Scott Trerotola 01/20/2017 10524 Douglas Uelmen 10/04/2013 10403, 11080 18 Carol Vierling 05/11/2016 10486, 11073 19 Mark Wilson 01/31/2017 10922 20 Natalie Wong 10/18/2016 10403 John Worland 03/16/2011 17582 15 16 17 21 22 23 24 25 26 27 28 7. Subject Matter Jurisdiction Ruling. The parties identified cases in the MDL for which federal subject matter jurisdiction does not exist. Docs. 20210, 21410, 21552. No federal question jurisdiction exists under 28 U.S.C. § 1331 because the master complaint asserts no federal claim and the state law claims alleged in the complaint do not depend on the resolution of a federal law question. Doc. 364 ¶¶ 166-349. For purposes of diversity jurisdiction under 28 U.S.C. § 1332, - 28 - 1 Defendant C. R. Bard, Inc. is a citizen of New Jersey and Defendant Bard Peripheral 2 Vascular, Inc. is a citizen of Arizona. See id. ¶¶ 11-12. Thus, complete diversity between 3 the parties does not exist in any case where each Defendant is a named party and Plaintiff 4 is a resident of either Arizona or New Jersey. See Doc. 20210-1. 5 Plaintiffs in most of the cases without subject matter jurisdiction agreed to a 6 dismissal without prejudice. See id. Plaintiffs in other cases opposed dismissal, but 7 provided no reason why the cases should not be dismissed. See id. The Court dismissed 8 without prejudice multiple cases for lack of subject matter jurisdiction. See Docs. 20667, 9 21461, 21579. Some of these cases may be refiled in state court. See Doc. 20210-1. 10 I. 11 Further Proceedings in Remanded or Transferred Cases. 1. General Discovery. 12 Because all general fact and expert discovery has been completed in this MDL, the 13 courts receiving these cases need not be concerned with facilitating general expert, 14 corporate, and third-party discovery. This observation is not meant to restrict the power of 15 transferee courts for good cause or in the interest of justice to address issues that may be 16 unique and relevant in a remanded or transferred case. 17 2. Case-Specific Discovery and Trial Preparation. 18 According to the parties, the status of the remaining discovery and other pretrial 19 issues for the cases being transferred, and the estimated time needed to resolve such issues 20 and make the cases ready for trial, will be determined after transfer. Final trial preparation 21 in the bellwether trials was governed by certain Court orders. See Docs. 8871, 10323, 22 10587, 11011, 11320, 11321, 11659, 11871, 12061, 12853, 12971. 23 J. 24 The Court has concluded that the cases listed on Schedule A should be transferred 25 to appropriate districts pursuant to 28 U.S.C. § 1404(a). Upon receipt of this transfer order, 26 the Clerk for this District shall issue a letter to the transferee courts, via email, setting out 27 the process for transferring the case. The letter and certified copy of this transfer order will 28 be sent to the transferee courts’ email addresses. Documents to Be Sent to Transferee Courts. - 29 - 1 The parties have submitted a stipulated designation of record for transferred cases. 2 See Doc. 21553-4; see also Doc. 19444-1. Upon receipt of this transfer order, the Clerk of 3 this District shall transmit to the transferee court the following: (1) a copy of the individual 4 docket sheet for the transferred action, (2) a copy of the master docket sheet in this MDL, 5 and (3) the record designated by the parties. 6 If a party believes that the docket sheet for a particular case being transferred is not 7 correct, a party to that case may, with notice to all other parties in the case, file with the 8 transferee court a designation amending the record. Upon receiving such designation, the 9 transferee court may make any needed changes to the docket. If the docket is revised to 10 include additional documents, the parties should provide those documents to the transferee 11 court. 12 III. 13 14 Conclusion. Pursuant to 28 U.S.C. § 1404(a), the Clerk of this District is directed to transfer the cases listed on Schedule A to appropriate districts for further proceedings. 15 The Clerk of this District is directed to unconsolidate two cases from the MDL: 16 Bernadette McBride v. C. R. Bard, Inc., No. 2:19-cv-02819, and Lonnie Easton v. C. R. 17 Bard, Inc., No. 2:19-cv-04274. These cases will remain in the District of Arizona and be 18 assigned to the undersigned judge. 19 IT IS SO ORDERED. 20 Dated this 10th day of September, 2020. 21 22 23 24 25 26 27 28 - 30 - In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641 TRANSFER ORDER (FOURTH) Schedule A – Direct-Filed Cases to Be Transferred (September 10, 2020) Case Caption Case Number Transferee District David L. Ball v. C.R. Bard, Inc. 2:17-cv-01681 Ala. N.D. Rickey Scott v. C.R. Bard, Inc. 2:19-cv-04063 Ala. S.D. Nicholas Blake Norton v. C.R. Bard, Inc. 2:17-cv-01900 Ala. S.D. Rita Rundel v. C.R. Bard, Inc. 2:19-cv-04235 Ark. E.D. Scottie C. Wolford v. C.R. Bard, Inc. 2:19-cv-01250 Ark. W.D. Shirely Ann Howard v. C.R. Bard, Inc. 2:17-cv-01734 Ark. W.D. Chleora Kay Bergquist v. C.R. Bard, Inc. 2:19-cv-03942 Cal. N.D. Alvis Edwards Deeds v. C.R. Bard, Inc. 2:19-cv-04272 Colo. Lisa Monique Wilkins v. C.R. Bard, Inc. 2:19-cv-03932 DC Nicole Subryan v. C.R. Bard, Inc. 2:17-cv-01729 DC Debra Ann Skinner v. C.R. Bard, Inc. 2:17-cv-02409 DC Sandra L. Olio v. C.R. Bard, Inc. 2:19-cv-03739 Fla M.D. Deborah St. John, Personal Representative for Sloan Christiansen v. C. R. Bard, Inc. 2:19-cv-03951 Fla. M.D. Sherry Lynn Black Goodrow v. C.R. Bard, Inc. 2:18-cv-00406 Fla. M.D. Robert Lee Felder v. C.R. Bard, Inc. 2:19-cv-03728 Fla. M.D. Tammy Lynn Young v. C.R. Bard, Inc. 2:19-cv-03989 Fla. M.D. Ross A. Grey v. C.R. Bard, Inc. 2:17-cv-04030 Fla. M.D. Kenneth Ivan Holbrook v. C.R. Bard, Inc. 2:19-cv-01234 Fla. M.D. Iarzella Marthe Dennard v. C.R. Bard, Inc. 2:19-cv-01539 Fla. M.D. James Wesley Jordan v. C.R. Bard, Inc. 2:19-cv-04110 Fla. S.D. Edmund Lucarelli, Jr. v. C.R. Bard, Inc. 2:18-cv-03675 Fla. S.D. Prudence Peterson v. C.R. Bard, Inc. 2:18-cv-02090 Fla. S.D. Theresa Melvin Mounsey v. C.R. Bard, Inc. 2:17-cv-02415 Fla. S.D. Carmen Delia Burgos v. C.R. Bard, Inc. 2:19-cv-02898 Fla. S.D. Steven Rogers v. C.R. Bard, Inc. 2:17-cv-04083 Ga. N.D. 1 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641 TRANSFER ORDER (FOURTH) Schedule A – Direct-Filed Cases to Be Transferred (September 10, 2020) Case Caption Case Number Transferee District Anthony Jackson v. C.R. Bard, Inc. 2:19-cv-01467 Ga. N.D. Mark Daniel Dills v. C.R. Bard, Inc. 2:19-cv-01512 Ga. N.D. Lauren Kent v. C.R. Bard, Inc. 2:19-cv-04076 Ga. S.D. Nancy Harmon v. C.R. Bard, Inc. 2:19-cv-00721 Ga. S.D. Linda Jenkins v. C.R. Bard, Inc. 2:18-cv-03935 Iowa N.D. Troy McKittrick v. C.R. Bard, Inc. 2:19-cv-03231 Ill. C.D. Karen Jandula v. C.R. Bard, Inc. 2:19-cv-02305 Ill. N.D. Richard Jason West v. C. R. Bard, Inc. 2:19-cv-03303 Ill. N.D. Delores Watson v. C.R. Bard, Inc. 2:17-cv-03990 Ind. S.D. Adam Kyle Fisher v. C.R. Bard, Inc. 2:17-cv-02805 Ind. S.D. Joanie Hansford, as Administrator of the Estate of Michele Hansford v. C. R. Bard, Inc. 2:19-cv-01526 Kan. Kristi G. Bailey v. C.R. Bard, Inc. 2:17-cv-04029 Ky. E.D. Phyllis Rae Steinhoff v. C.R. Bard, Inc. 2:19-cv-03965 Ky. W.D. Reba Carter v. C.R. Bard, Inc. 2:19-cv-01457 Ky. W.D. Michael J. Palmer v. C.R. Bard, Inc. 2:19-cv-04227 La. E.D. Wayne Francis Melancon, Sr. v. C.R. Bard, Inc. 2:17-cv-01733 La. E.D. Marc J. Houle v. C.R. Bard, Inc. 2:17-cv-01705 Mass. Kandy Carpenter v. C.R. Bard, Inc. 2:19-cv-01525 Mich. E.D. Thomas Orest v. C.R. Bard, Inc. 2:17-cv-04095 Minn. Naomi Gardner v. C.R. Bard, Inc. 2:19-cv-04294 Mo. W.D. Penni Hendrickson v. C.R. Bard, Inc. 2:19-cv-04073 Mo. W.D. Kathy Lucille Spencer v. C.R. Bard, Inc. 2:19-cv-03944 Mo. W.D. Lisa Johnson v. C.R. Bard, Inc. 2:19-cv-02001 Mo. W.D. Sarah Rosalie Mobley v. C.R. Bard, Inc. 2:17-cv-02239 Mo. W.D. Sandra Risner v. C.R. Bard, Inc. 2:19-cv-02136 Miss. N.D. 2 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641 TRANSFER ORDER (FOURTH) Schedule A – Direct-Filed Cases to Be Transferred (September 10, 2020) Case Caption Case Number Transferee District Shari Alaine Maresh v. C.R. Bard, Inc. 2:19-cv-01632 N.C. E.D. Kristine Louise Allsbury v. C.R. Bard, Inc. 2:19-cv-03781 N.C. M.D. Jeremy Gates v. C.R. Bard, Inc. 2:19-cv-01498 N.C. W.D. Nichols R. Garon v. C.R. Bard, Inc. 2:19-cv-01238 N.H. Buntricia Bastian v. C.R. Bard, Inc. 2:19-cv-00369 Nev. Michael Campobasso v. C.R. Bard, Inc. 2:19-cv-01575 Nev. Carolyn Sue Cuyler v. C.R. Bard, Inc. 2:17-cv-01704 Nev. Kevin Carenza v. C.R. Bard, Inc. 2:19-cv-03979 N.Y. E.D. Clyde Solomon v. C.R. Bard, Inc. 2:19-cv-01466 N.Y. E.D. Christopher Beasock v. C.R. Bard, Inc. 2:19-cv-01465 N.Y. E.D. Jimmy Reed Dillard, Jr. v. C.R. Bard, Inc. 2:19-cv-04273 N.Y. N.D. Marie Spencer v. C.R. Bard, Inc. 2:19-cv-04053 N.Y. S.D. Agnes Roberts v. C.R. Bard, Inc. 2:17-cv-00138 N.Y. S.D. Gloria Cleveland v. C.R. Bard, Inc. 2:19-cv-04179 N.Y. W.D. Deborah S. Hamby v. C.R. Bard, Inc. 2:19-cv-01449 N.Y. W.D. Kimberly Roberts v. C.R. Bard, Inc. 2:18-cv-02828 Ohio N.D. Sherrie Lynn Butler v. C.R. Bard, Inc. 2:17-cv-01142 Ohio N.D. Jeramey Kohar v. C.R. Bard, Inc. 2:19-cv-01780 Ohio S.D. Edward Schaab v. C.R. Bard, Inc. 2:19-cv-02133 Ohio S.D. Keyon Phillip Williams v. C.R. Bard, Inc. 2:17-cv-00606 Ohio S.D. Keith L. Bryant v. C.R. Bard, Inc. 2:17-cv-01703 Ohio S.D. Jessica Jean Johnson v. C.R. Bard, Inc. 2:17-cv-01706 Ohio S.D. Adlen June Silas v. C.R. Bard, Inc. 2:17-cv-01707 Ohio S.D. Tina M. Savage v. C.R. Bard, Inc. 2:17-cv-01731 Ohio S.D. William Dennie Evans, III v. C.R. Bard, Inc. 2:17-cv-01816 Ohio S.D. Lillie Elizabeth Wilburn v. C.R. Bard, Inc. 2:17-cv-02555 Ohio S.D. 3 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641 TRANSFER ORDER (FOURTH) Schedule A – Direct-Filed Cases to Be Transferred (September 10, 2020) Case Caption Case Number Transferee District Rudy Headley v. C.R. Bard, Inc. 2:19-cv-01497 Okla. W.D. William Murphy v. C.R. Bard, Inc. 2:19-cv-04233 Pa. E.D. Douglas J. Dohan v. C.R. Bard, Inc. 2:19-cv-04069 Pa. E.D. Justin Ubel v. C.R. Bard, Inc. 2:19-cv-02073 Pa. E.D. Rachel Evans v. C.R. Bard, Inc. 2:19-cv-04225 Pa. M.D. Clinton Elliott Hufnagle v. C.R. Bard, Inc. 2:19-cv-03244 Pa. M.D. Jeanette McFarland v. C.R. Bard, Inc. 2:19-cv-01511 Pa. W.D. James O. Roberts v. C.R. Bard, Inc. 2:19-cv-03625 S.C. Charles Ronald Finch v. C.R. Bard, Inc. 2:19-cv-01533 S.C. Bruce R. Cunningham v. C.R. Bard, Inc. 2:19-cv-01236 Tex. E.D. Franky Williams v. C.R. Bard, Inc. 2:19-cv-04070 Tex. N.D. Bryon Kelly Rieken v. C.R. Bard, Inc. 2:19-cv-04061 Tex. N.D. Dale Anthony Hall v. C.R. Bard, Inc. 2:19-cv-04058 Tex. N.D. Alejandro G. Santana v. C.R. Bard, Inc. 2:18-cv-02264 Tex. S.D. James Shutter v. C.R. Bard, Inc. 2:19-cv-03345 Tex. S.D. Melissa Jane Sepeda v. C.R. Bard, Inc. 2:18-cv-01585 Tex. S.D. Edward Lee Smith v. C.R. Bard, Inc. 2:19-cv-01630 Tex. W.D. Charles Henry Wand v. C.R. Bard, Inc. 2:19-cv-02098 Tex. W.D. Robert John Allsopp v. C.R. Bard, Inc. 2:19-cv-04049 Tex. W.D. Peggy Sue Clarke v. C.R. Bard, Inc. 2:19-cv-03727 Va. E.D. David S. Breeden v. C.R. Bard, Inc. 2:19-cv-01535 Va. E.D. Benjamin Kwame Quarmon v. C.R. Bard, Inc. 2:17-cv-00335 Va. E.D. Johnie W. Dalton v. C.R. Bard, Inc. 2:19-cv-04268 Va. W.D. Norman E. Rose v. C.R. Bard, Inc. 2:19-cv-04083 Wa. W.D. Kelly Kuester v. C.R. Bard, Inc. 2:19-cv-02904 Wis. E.D. Jody Marie Snyder v. C.R. Bard, Inc. 2:17-cv-03272 Wis. W.D. 4 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641 TRANSFER ORDER (FOURTH) Schedule A – Direct-Filed Cases to Be Transferred (September 10, 2020) Case Caption Case Number Transferee District Chasity Adkins v. C.R. Bard, Inc. 2:19-cv-04261 W.V. S.D. Angela Rhodes v. C.R. Bard, Inc. 2:19-cv-02135 W.V. S.D. 5 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 1 – MDL Orders CASE MANAGEMENT ORDERS (CMOs) Date Filed Doc. No. Docket Text 10/30/2015 248 CMO 1 re Leadership Counsel Appointments 11/16/2016 4016 Amended CMO 1 re Leadership Counsel Appointments 03/21/2017 5285 Second Amended CMO 1 re Plaintiff Leadership Team 02/04/2019 15098 Third Amended CMO 1 re Plaintiff Leadership Team 10/30/2015 249 CMO 2 re Setting Deadlines, First Phase of Discovery 12/01/2015 314 CMO 3 re Non-waiver Order Pursuant to Rule 502(d) 12/17/2015 363 CMO 4 re Master Complaint, Responsive Pleadings, Short Form Complaint, Waiver, and Answer 3/17/2016 1108 Amended CMO 4 re Master Complaint, Responsive Pleadings, Short Form Complaint, Waiver, and Answer 4/20/2016 1485 Second Amended CMO 4 re Master Complaint, Responsive Pleadings, Short Form Complaint, Waiver, and Answer 12/17/2015 365 CMO 5 re Plaintiff and Defendant Profile Forms 03/03/2016 927 Amended CMO 5 re Plaintiff and Defendant Profile Forms 12/18/2015 372 CMO 6 re Rules to Establishing Common Benefit Fee 01/05/2016 401 CMO 7 re Stipulations Concerning Redactions 02/02/2016 519 CMO 8 re Second Phase of Discovery 03/31/2016 1259 CMO 9 re ESI and production protocol 04/01/2016 1319 CMO 10 re Second Phase Discovery, Bellwether, ESI, FDA, Deposition, and Privilege Log 05/05/2016 1662 CMO 11 re Bellwether Selection Process 05/05/2016 1663 CMO 12 re Joint Record Collection 06/21/2016 2238 CMO 13 re ESI, FDA Warning Letter and Designations 06/21/2016 2239 CMO 14 re Deposition Protocols 1 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC CASE MANAGEMENT ORDERS (CMOs) Date Filed Doc. No. Docket Text 08/25/2016 3214 CMO 15 re Lexecon Waivers, ESI Discovery, Multi-plaintiff Actions, and Deceased Plaintiffs 08/25/2016 3215 CMO 16 re Deadlines Related to Barraza 12/02/2016 4141 Amended CMO 16 re Deadlines Related to Barraza 09/14/2016 3372 CMO 17 re Protective Order and Expedited ESI Production 11/16/2016 4015 Amended CMO 17 re Protective Order and Redactions of Material from Expedited ESI Production 10/17/2016 3685 CMO 18 re Adjusted Discovery Schedule 12/13/2016 4311 CMO 19 re ESI and Bellwether Selection 12/22/2016 4335 CMO 20 re Discovery Deadlines for Discovery Group 1 and Bellwether Group 1 02/06/2017 4866 CMO 21 re Discovery Protocols for Discovery Group 1 02/17/2017 5007 CMO 22 re Setting Deadlines 05/05/2017 5770 CMO 23 re Expert Deposition Deadlines, Bellwether Case Selection, Preemption Motion for Summary Judgment, and Mature Cases 05/19/2017 5881 CMO 23 re Discovery Protocols for Bellwether Group 1 05/19/2017 5883 Amended CMO 24 re Discovery Protocols for Bellwether Group 1 06/06/2017 6227 CMO 25 re Bellwether Group 1 Amended Discovery Schedule 07/17/2017 6799 CMO 26 re Depositions of Dr. Henry and Dr. Altonaga, Communications among Plaintiffs’ Experts, and Bellwether Trial Issues 10/10/2017 8113 CMO 27 re Privilege Issues, Bellwether Trial Schedule, Plaintiffs’ Motion for Partial Summary Judgment, and Recusal Unnecessary 11/21/2017 8871 CMO 28 re Booker Bellwether Trial Schedule, and Mature Cases 2 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC CASE MANAGEMENT ORDERS (CMOs) Date Filed Doc. No. Docket Text 12/21/2017 9415 CMO 29 re Booker Bellwether Trial Schedule, Motion to Certify Appeal, and Cisson Motion Briefing 01/23/2018 9775 CMO 30 re Motions Hearings, Motions in Limine, and Punitive Damages in Booker 03/02/2018 10323 CMO 31 re Booker Trial 05/07/2018 11011 CMO 32 re Jones Trial 06/01/2018 11320 CMO 33 re Mulkey as Next Bellwether Selection, and Mulkey Trial Schedule 06/28/2018 11659 CMO 34 re Next 3 Bellwether Trials, Kruse Trial Schedule, Use of Dr. Kandarpa at Trial, Sixth Bellwether Tinlin, Disposition of SNF Cases, and Remand of Mature Cases 07/13/2018 11871 CMO 35 re September, November and May Bellwether Trials, and Hyde September Bellwether Trial Schedule 08/02/2018 12061 CMO 36 re Tinlin Bellwether Pre-trial Schedule 10/04/2018 12830 CMO 37 re Hyde Trial 10/05/2018 12853 CMO 38 re Future Bellwether Trials, February and May Bellwether Trials, Motion to Seal Trial Exhibits, Settlement Talks and Remand, and SNF Cases 10/16/2018 12971 CMO 39 re Tinlin Bellwether Case 11/08/2018 13329 CMO 40 re Mulkey Bellwether Trial 02/08/2019 15176 CMO 41 re Tinlin Trial, SNF Cases, Remand of Mature Cases, and Possible Settlement Procedures 03/21/2019 16343 CMO 42 re Tinlin Trial, SNF Cases, Duplicative Cases, Settlement Procedures and Remand or Transfer 05/02/2019 17494 CMO 43 re Tinlin Trial, Common Benefit Fund Fee and Expense Accounts, Closing Date for New Cases and Remand or Transfer, and SNF Cases 05/16/2020 17777 CMO 44 re Common Benefit Fund Accounts 05/31/2020 18079 CMO 45 re MDL closure 3 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC CASE MANAGEMENT ORDERS (CMOs) Date Filed Doc. No. Docket Text 03/27/2020 21480 CMO 46 re Common Benefit Fee and Cost Committee (Sealed Ex Parte Order) 06/29/2020 21528 Amended CMO 46 (Sealed Ex Parte Order) 07/16/2020 21540 CMO 47 re settlement status of cases and cases dismissed without prejudice DISCOVERY ORDERS Date Filed Doc. No. Docket Text 10/30/2015 249 CMO 2 re Setting Deadlines, First Phase of Discovery 02/02/2016 519 CMO 8 re Second Phase of Discovery 03/31/2016 1259 CMO 9 re Electronically Stored Information and production protocol 04/01/2016 1319 CMO 10 re Second Phase Discovery, Bellwether, ESI, FDA, Deposition, and Privilege Log 05/05/2016 1663 CMO 12 re Joint Record Collection 06/21/2016 2238 CMO 13 re ESI, FDA Warning Letter and Designations 06/21/2016 2239 CMO 14 re Deposition Protocols 08/25/2016 3214 CMO 15 re Lexecon Waivers, ESI Discovery, Multi-plaintiff Actions, and Deceased Plaintiffs 08/29/2016 3272 Order re Deposition of Jim Beasley 09/06/2016 3312 Order re discovery disputes concerning Plaintiffs’ communications with FDA 09/06/2016 3313 Order re Plaintiffs’ communications with NBC or other media outlets and admissibility at trial 09/06/2016 3314 Order re Plaintiffs’ third party funding arrangements 09/14/2016 3372 CMO 17 re Protective Order and Expedited ESI Production 4 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC DISCOVERY ORDERS Date Filed Doc. No. Docket Text 11/16/2016 4015 Amended CMO 17 re Protective Order and Redactions of Material from Expedited ESI Production 09/16/2016 3398 Order re ESI generated by foreign entities that sell filters abroad 10/17/2016 3685 CMO 18 re Adjusted Discovery Schedule 12/13/2016 4311 CMO 19 re ESI and Bellwether Selection 12/22/2016 4335 CMO 20 re Discovery Deadlines for Discovery Group 1 and Bellwether Group 1 12/24/2016 4339 Order re proposed depositions of and interrogatories to Plaintiffs’ counsel 02/06/2017 4865 Order re discovery dispute on ex parte communications with treating physicians and depositions of treating physicians and sales representatives 02/06/2017 4866 CMO 21 re Discovery Protocols for Discovery Group 1 05/05/2017 5770 CMO 23 re Expert Deposition Deadlines, Bellwether Case Selection, Preemption Motion for Summary Judgment, and Mature Cases 05/19/2017 5881 CMO 23 re Discovery Protocols for Bellwether Group 1 05/19/2017 5883 Amended CMO 24 re Discovery Protocols for Bellwether Group 1 06/06/2017 6227 CMO 25 re Bellwether Group 1 Amended Discovery Schedule 07/17/2017 6799 CMO 26 re Depositions of Dr. Henry and Dr. Altonaga, Communications among Plaintiffs’ Experts, and Bellwether Trial Issues 5 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC DISCOVERY AND PRIVILEGE ORDERS Date Filed Doc. No. Docket Text 12/01/2015 314 CMO 3 re Non-waiver Order Pursuant to Rule 502(d) 02/11/2016 699 Order re Motion for Protective Order concerning Dr. John Lehmann's December 15, 2004, report as protected work product 07/25/2016 2813 Order re Plaintiffs’ Motion to Compel (Privilege Log Issues) 02/06/2017 4865 Order re discovery dispute on ex parte communications with treating physicians and depositions of treating physicians and sales representatives 07/17/2017 6799 CMO 26 re Depositions of Dr. Henry and Dr. Altonaga, Communications among Plaintiffs’ Experts, and Bellwether Trial Issues 10/10/2017 8113 CMO 27 re Privilege Issues, Bellwether Trial Schedule, Plaintiffs’ Motion for Partial Summary Judgment, and Recusal Unnecessary 10/20/2017 8315 Order that Plaintiffs need not produce the withheld expert communications or provide a privilege log on these communications to Defendants. DAUBERT ORDERS Date Filed Doc. No. Docket Text 12/21/2017 9428 Order re Motion to Disqualify Plaintiffs' Expert Thomas Kinney, M.D. 12/21/2017 9432 Order re Motion to Disqualify Plaintiffs' Experts Drs. Resnick, Vogelzang, and Desai 12/22/2017 9433 Order re Motion to Exclude Plaintiffs' Experts Drs. Parisian and Kessler 12/22/2017 9434 Order re Motion to Exclude Plaintiffs' Experts Drs. Kinney, Roberts, and Kalva 01/22/2018 9770 Order re Motion to Exclude Plaintiffs' Expert Dr. Eisenberg 01/22/2018 9771 Order re Motion to Exclude Plaintiffs' Expert Dr. Muehrcke 6 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC DAUBERT ORDERS Date Filed Doc. No. Docket Text 01/22/2018 9772 Order re Motion to Exclude Plaintiffs' Expert Dr. Hurst 01/22/2018 9773 Order re Motion to Exclude Plaintiffs' Expert Dr. Betensky 02/06/2018 9991 Order re Motion to Exclude Bard's Expert Dr. Grassi 02/08/2018 10051 Order re Motion to Exclude Plaintiffs' Expert Dr. McMeeking 02/08/2018 10052 Order re Motion to Exclude Plaintiffs' Expert Dr. Ritchie 02/12/2018 10072 Order re Motion to Exclude Plaintiffs' Experts Drs. Garcia and Streiff 02/21/2018 10230 Order re Motion to Exclude Bard's Experts Drs. Grassi and Morris 02/21/2018 10231 Order re Motion to Exclude Bard's Expert Dr. Morris 04/16/2019 16992 Order re Motion to Exclude Plaintiffs’ Expert Dr. McMeeking 04/23/2019 17285 Order re Motion to Exclude Bard’s Expert Dr. Morris MOTIONS IN LIMINE ORDERS Date Filed Doc. No. Docket Text 01/23/2018 9775 CMO 30 re Motions Hearings, Motions in Limine, and Punitive Damages in Booker 01/26/2018 9861 Joint Stipulation re prohibiting raising certain issues in the presence of the jury for Booker Bellwether case 01/29/2018 9881 Order re admissibility of (1) pre-market clearance of Bard IVC filters by FDA and (2) the lack of FDA Enforcement Action against Bard 02/15/2018 10075 Order re Motions in Limine re Photographs of Mike Randall, Dr. Kinney work for Bard, Benevolent Activities, Evidence Not Produced in Complaint Files, Prior Judicial Opinions, Adverse Impact of a Plaintiff's Verdict, Informed Consent 7 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC MOTIONS IN LIMINE ORDERS Date Filed Doc. No. Docket Text Form, Dr. Kang Social Media Posts, Personal Traits of Employees and Witnesses for Booker Bellwether case 02/22/2018 10235 Order re Parties' Joint Stipulation re prohibiting raising certain issues in the presence of the jury for Booker Bellwether case 03/01/2018 10258 Order re Motions in Limine re Recovery® Filter Complications, Recovery® Filter Development, FDA Warning Letter, IVC Filter as Lifesaving Devices, IVC filters are Gold Standard, Nonparties at Fault, Statements from Associations and Other Groups, FDA Consent for Warnings or Recalls for Booker Bellwether case 03/09/2018 10382 Order re Plaintiff's use of the depositions of Drs. Moritz, Rogers, and Stein at trial 03/19/2018 10489 Order re Simon Nitinol Filter complication evidence 04/18/2018 10819 Order re reconsideration motions relating to Recovery® Filter Evidence and cephalad Migration Deaths for Jones Bellwether case 04/27/2018 10920 Order re Plaintiff’s motion for reconsideration of Court Order excluding evidence of Recovery® Filter Cephalad Migration Deaths for Jones Bellwether case 05/03/2018 10947 Order re Motions in Limine re (1) Case Specific Medical Issues (2) Relatives receipt of IVC Filters, (3) Experts Retained In Other Litigation, (4) Attorney Advertising, (5) Other Lawsuits for Jones Bellwether case 05/08/2018 11041 Order re cephalad migration deaths for Jones Bellwether case 05/15/2018 11082 Order re reconsideration of Recovery migration deaths 05/29/2018 11256 Order re cephalad migration, Recovery filter and deaths and FDA evidence for Jones Bellwether case 09/04/2018 12507 Order re SIR Guidelines and IFU for Hyde Bellwether case 09/07/2018 12533 Order re cephalad migration deaths, SNF as reasonable alternative design, personal opinions of Dr. Muehrcke, informed consent, FDA evidence, Surgeon General’s Call to Action, and falling accidents for Hyde Bellwether case 8 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC MOTIONS IN LIMINE ORDERS Date Filed Doc. No. Docket Text 04/23/2019 17285 Order re medical care as an intervening cause of injury for Tinlin Bellwether case 04/26/2019 17401 Order re Ms. Tinlin’s IVC Size, unrelated medical conditions, rates of filter complications, retrievable filter sales versus SNF sales, social security benefits, cephalad migration deaths, FDA warning letter, crisis communications plan, and patient at Dr. Muehrcke’s hospital for Tinlin Bellwether case DEPOSITION DESIGNATION ORDERS Date Filed Doc. No. Docket Text 03/07/2018 10348 Order re deposition designations for Booker Bellwether case 03/12/2018 10403 Order re deposition designations for Booker Bellwether case 03/14/2018 10438 Order re deposition designations for Booker Bellwether case 03/19/2018 10486 Order re deposition designations for Booker Bellwether case 03/21/2018 10497 Order re deposition designations for Booker Bellwether case 03/26/2018 10524 Order re deposition designations for Booker Bellwether case 05/01/2018 10922 Order re deposition designations for Jones Bellwether case 05/10/2018 11064 Order re deposition designations for Jones Bellwether case 05/11/2018 11073 Order re deposition designations for Jones Bellwether case 05/14/2018 11080 Order re deposition designations for Jones Bellwether case 05/31/2018 11313 Order re deposition designations for Jones Bellwether case 08/27/2018 12357 Order re deposition designations for Hyde Bellwether case 09/04/2018 12508 Order re deposition designations for Hyde Bellwether case 09/12/2018 12590 Order re deposition designations for Hyde Bellwether case 09/13/2018 12595 Order re deposition designations for Hyde Bellwether case 09/17/2018 12598 Order re deposition designations for Hyde Bellwether case 9 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC DEPOSITION DESIGNATION ORDERS Date Filed Doc. No. Docket Text 04/26/2019 17386 Order re deposition designations for Tinlin Bellwether case 05/03/2019 17513 Order re deposition designations for Tinlin Bellwether case 05/07/2019 17582 Order re deposition designations for Tinlin Bellwether case MISCELLANEOUS ORDERS Date Filed Doc. No. Docket Text 11/10/2015 269 Amended Stipulated Protective Order re Confidentiality 11/22/2017 8872 Order re Bard’s Motion for Summary Judgment on Preemption Grounds 11/22/2017 8874 Order re Bard’s Motion for Summary Judgment for Booker Bellwether case 03/12/2018 10404 Order re Bard’s Motion for Summary Judgment for Jones Bellwether case 03/30/2018 10587 Order re final trial preparation and setting Final Pretrial Conference for Jones Bellwether case. 06/01/2018 11321 Order re final trial preparation and setting Final Pretrial Conference for Mulkey Bellwether case. 06/28/2018 11659 Order re final trial preparation and setting Final Pretrial Conference for Kruse Bellwether case. 07/13/2018 11871 Order re final trial preparation and setting Final Pretrial Conference for Hyde Bellwether case. 07/26/2018 12007 Order re Bard’s Motion for Summary Judgment for Hyde Bellwether case 08/02/2018 12061 Order re final trial preparation for Tinlin Bellwether case. 08/17/2018 12202 Order re Bard’s Motion for Summary Judgment for Kruse Bellwether case 09/12/2018 12589 Order re Preemption of Negligence Per Se for Hyde Bellwether case 10 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC MISCELLANEOUS ORDERS Date Filed Doc. No. Docket Text 09/13/2018 12593 Order re reconsideration of Order denying Wisconsin Government Rules Rebuttable Presumption of Non-Defect for Hyde Bellwether case 10/05/2018 12853 Order re amended schedule for final trial preparation and setting Final Pretrial Conference for Mulkey and Tinlin Bellwether cases. 10/16/2018 12971 Order re amended schedule for final trial preparation and setting Final Pretrial Conference for Tinlin Bellwether case. 04/16/2019 17008 Order re Bard’s Motion for Summary Judgment for Tinlin Bellwether case 05/31/2019 18038 Order re Plaintiffs Steering Committee’s Motion to Modify CMO 6 to Increase the Common Benefit Assessments 03/04/2020 21461 Order Addressing Cases with Service of Process and Plaintiff Profile Form Issues, Cases for Which No Federal Jurisdiction Exists, and Duplicate Cases 07/08/2020 21527 Order re vacating dismissals of cases dismissed without prejudice MASTER AND SHORT-FORM PLEADINGS Date Filed Doc. No. Docket Text 10/30/2015 249 CMO 2 re Setting Deadlines, First Phase of Discovery 12/17/2015 363 CMO 4 re Master Complaint, Responsive Pleadings, Short Form Complaint, Waiver, and Answer 3/17/2016 1108 Amended CMO 4 re Master Complaint, Responsive Pleadings, Short Form Complaint, Waiver, and Answer 4/20/2016 1485 Second Amended CMO 4 re Master Complaint, Responsive Pleadings, Short Form Complaint, Waiver, and Answer 12/17/2015 364 Master Complaint for Damages for Individual Claims 11/30/2015 302 Master Short Form Complaint for Damages for Individual Claims 11 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC MASTER AND SHORT-FORM PLEADINGS Date Filed Doc. No. Docket Text 12/17/2015 366 Defendants’ Answer to Plaintiffs’ Master Complaint 12/17/2015 365 CMO 5 re Plaintiff and Defendant Profile Forms 03/03/2016 927 Amended CMO 5 re Plaintiff and Defendant Profile Forms 03/18/2016 1153-1 Plaintiff Fact Sheet 03/18/2016 1153-2 Defendant Fact Sheet 12 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 79 2/19/2004 Characterization of RNF - Migration resistance; TPR-04-02-02 REV 0 Test protocol for migration resistance Characterization of RNF - Migration resistance 354 9/19/2006 PPT re G2; Caudal Movement causes tilting which leads to perforation PPT last modified 3/16/2009 (custodian Mike Randall) 443 11/30/2008 G2 and G2X Fracture Analysis Reporting date range 7/1/2005 thru 11/30/2008 447 4/1/2009 Filter - Fracture Analysis (June 2010) 495 3/26/2015 Recovery Filter System; Recovery Filter Overview 504 Eclipse Concept POA 545 Altonaga Deposition, 10/22/2013, Exhibit 03 - 2/26-2/27/2004 E-mail exchange b/w Hudnall and David Rauch of BPV Re. "Case for Caval Centering" 546 Altonaga Deposition, 10/22/2013, Exhibit 04, Lehmann Deposition 4/2/13, Ex. 14 and Ferarra, Ex. 7, Barry Deposition, 01/31/2014, Exhibit 18 - 4/13-4/15/2004 E-mail exchange b/w Lee Lynch, Lehmann, and others Re. "Crisis Plan and Supporting Documents for Your Review" 552 Asch 202, 5/18/1999 Letter from Thomas Kinst, Product Manager of Filters at NMT Medical, to Monica Coutanche, Marketing Manager at Bard Canada, Inc. 553 Asch Deposition, 05/02/2016 - Exhibit 203 - 9/14/2002 Memo from Thomas Kinst to Recovery Filter Design History File Re. Recovery Filter Compassionate Use, Subject: "Conference call with Bard Peripheral Technologies regarding clinical assessment of Recovery Filter removal #5" 556 Asch Deposition, 05/02/2016 - Exhibit 207 - 1/26/2001 Letter from Mount Sinai Hospital to Dr. Asch Re. "Assessment of a New Temporary/Removable IVC Filter" - and - 11/8/2001 Letter from Mount Sinai Research Ethics Board Re. "MSH Reference #01-0161-U 557 Asch Ex. 208, BPV-17-01-00056765 -766, /28/2000 E-mail from Paul Stagg to Cavagnaro, Mellen, Uelmen, Vierling, and Field Re. "Fwd [2]: compassionate IVC filters" (from Asch) 559 Asch Exh. 210, BPV-17-01-00052621, 4/17/2002- Email from George Cavagnaro to Doug Uelmen and Carol Vierling, dated April 18, 2002 1 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 561 Asch Deposition, 05/02/2016 - Exhibit 212 - Special 510(k) Submission for the Recovery Filter System, K022236, dated 11/27/2002 563 Asch Deposition, 05/02/2016 - Exhibit 218 - Information for Use - Recovery Filter System, Dated 2004 567 Asch Deposition, 05/02/2016 - Exhibit 223 - 3/10/2003 Letter from Dr. Asch Re support for RF 571 Baird Deposition, 06/09/2016 - Exhibit 301 - PowerPoint Presentation entitled BPV Filter Franchise Review dated 5/6/2008 (colored and 43 pages) 587 Baird Deposition, 06/09/2016 - Exhibit 318 - Aug. 2010 Article by Nicholson et al. entitled "Online First: Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade" 588 Baird Deposition, 06/09/2016 - Exhibit 319 - 11/12/2009 E-mail from Bret Baird to Bill Little, John Van Vleet, and Gin Schulz, with others CC’ed, Re. "Bard Filter Fractures presentation online" 589 Baird Deposition, 06/09/2016 - Exhibit 320 - ABA Project Agreement with BPV, Inc., dated 11/9/2010 590 Baird Deposition, 06/09/2016 - Exhibit 321 - 11/29-12/1/2010 E-mail exchange b/w Bret Baird and Jimmy Balwit Re. "White Paper, Proof 2" 591 Baird Deposition, 06/09/2016 - Exhibit 322 - Bard Idea POA on the Denali Filter, Project No. 8108 Rev. 0.0, revised August 2009 by Bret Baird 592 Baird Deposition, 06/09/2016 - Exhibit 325 - 4/28/2010 E-mail from Bret Baird to the Sales Team 614 Betensky 02/2017 Expert Report - Adverse event reports and monthly sales totals through May 2011 631 Betensky Expert Report - DFMEA070044, Rev. 3: G2 Express - Design Failure Mode and Effects Analysis 635 Betensky Expert Report - DFMEA070077, Rev. 1: Eclipse (Vail) Filter System - Design Failure Mode and Effects Analysis 677 SOF Filter Fracture Analysis, August 2010, Reporting range 7/1/05 - 8/31/10, G2, G2X, and Eclipse 691 Boyle, 02/02/2017, Exhibit 842 - E-mail chain first one from John Van Vleet to Steve Williamson, dated 11/5/2015, 6 pages 2 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 696 Brauer Deposition, 05/23/2014 - Exhibit 16 - Testimony of Marcia Crosse, Director of Health Care, before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives Re. "Medical Devices ¬Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments", dated 6/18/2009 709 Brauer, 08/02/2017, Exhibit 1046 - Bard Simon Nitinol Filter, Postmarket Surveillance Study Amendment, August 10, 2014 730 Carr Deposition, 04/17/2013 - Exhibit 01 - Class of Plaintiffs' Notice of Taking Rule 30(b)(6) Deposition Duces Tecum in Case No. 12-80951- CIV-ROSENBAUM 735 Carr Deposition, 04/17/2013 - Exhibit 07 - Bard Idea POA - Eclipse Anchor Filter, caudal migration, Rev 0, 4/1/2010 E-mail exchange b/w Tracy Estrada and Ed Fitzpatrick 737 Carr Deposition, 04/17/2013 - Exhibit 09 - 8/22-8/25/2008 E-mail exchange b/w Bret Bard, Mike Randall, and Natalie Wong Re. "[Redacted] Conference call - complaint on fracture" 755 Carr Deposition, 10/29/2014 - Exhibit 3A - E-mail exchange b/w Hudnall and others from 3/9-10/4/2005 Re. "Special Accounts Roadshow" 764 REDACTED Carr Deposition, 11/05/2013 - Exhibit 14 - 5/27/2004 E-mail b/w Greer, Carr, Hudnall, and Sullivan re. "Bariatric patients and filters", "Stay out of the buffet line", BPVE-01-00010858 -859 769 Carr Deposition, 12/19/2013 - Exhibit 05 - BPV Meridian Claims Matrix, dated 7/2/2010 770 Carr Deposition, 12/19/2013 - Exhibit 06 - Bard's Denali Concept Product Opportunity Appraisal, POA-8108, Rev. 1.0 800 Carr Deposition, 12/19/2014 - Exhibit 18 - NMT RNF PDT Meeting Notes re Product Development Team, 01/13/1998 802 Carr Deposition, 12/19/2014 - Exhibit 20 - NMT R&D Technical Report, RD-RPT-128, 09/01/2000, Investigation Report of a Migrated Recovery Filter in the Human Use Experience at Mt. Sinai Hospital 854 REDACTED Carr Deposition, November 5, 2013 - Exhibit 15 - 12/12/2004 E-mail from Uelmen to Kellee Jones, attaching 12/9/2004 Remedial Action Plan (Revised) SPA-04-12-01 3 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 876 Chanduszko Deposition, 04/23/2015 - Exhibit 17 - Pages 30-44 of Notebook No. 7013, Project: Recovery Filter Arm Fatigue Testing 905 Ferrara Exh. 19, BPVE-01-00245186 -188, Email chain re G2 Caudal Migrations 12/27/2005 922 Ciavarella Deposition, 11/12/2013 - Exhibit 22 - Chart of Sales and Adverse Events for all competitors from Q3/00 through Q2/03, according to the MAUDE database. 923 Ciavarella Deposition, 11/12/2013 - Exhibit 24 - Summary of Sales and Adverse Events for all competitors from 01/00 through Q1/04 924 Ciavarella Deposition, 11/12/2013 - Exhibit 26 - Chart of Sales and Adverse Events for all competitors from 01/00 through Q1 2006, according to the MAUDE database. 925 Ciavarella Deposition, 11/12/2013 - Exhibit 28 - PowerPoint presentation entitled "Filters Complaint History Data as of 7/31/2007" by Natalie Wong. 926 REDACTED Ciavarella Deposition, 11/12/2013 - Exhibit 31 - 8/3/2005 Memo from C. Ganser to T. Ring/J. Weiland Re. IVC Recovery Filter Adverse Events (Migrations/Fractures) 927 Ciavarella Deposition, 11/12/2013 - Exhibit 35 - Health Hazard Evaluation Memo from Ciavarella to Uelmen Re. "Recovery Filter - Consultant's report", dated 12/17/2004 931 Ciavarella Deposition, 11/12/2013 - Exhibit 39 - Draft of Updated Health Hazard Evaluation Memo from Ciavarella to Uelmen, re: "Limb Fractures of Recovery Filter", dated 7/9/2004. 932 SWOT Analysis; 5/6/2008 PowerPoint presentation entitled "Filter Franchise Review" BPVE-01-00622862 - 900 945 Cohen Exh. 736, BPVE-01-00074004 - 006, IVC Filters - Covered Stents, Monthly Report April, 2004 965 Cohen Exh. 757, BPVEFILTER-01-00148562, E-mail dated 12/15/04, with attached FDA Filter Information, FDA called Temple to speak with Cohen 991 Cortelezzi, 11/11/2016, Exhibit 586 - 12/23/2005 E-mail from David Ciavarella Re. "G2 Caudal Migrations", forwarded to Brian Barry on 12/27. Worst case consequence of migrations - accompanied in a majority of tilt cases. Would like to now look at G2 complaints. 4 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 992 Cortelezzi, 11/11/2016, Exhibit 588 - 7/16/2005 E-mail from Jason Greer to many Re. "Westy's situation…everyone's situation", detailing Bard's need to respond to Cordis' bringing forward the Maude database to physicians and "causing a problem" 994 D'Ayala Exh. 4, G2 Filter System for Permanent Placement, IFU, G2 Filter System, 10/2006, Rev. 5, PK5100030, BPV-17-01-00137425 - 432 (also used with Muehrcke) 1001 D'Ayala Exh. 13, Evidence-Based Evaluation of Inferior Vena Cava Filter Complications Based on Filter Type 1006 DeCant Deposition, 05/24/2016 - Exhibit 254 - 12/9/2003 Meeting Minutes Memo from Brian Hudson to Len DeCant, Mike Casanova, Robert Carr, and Alex Tessmer Re. "Special Design Review for Recovery (Project #'s 7081 and 8008)" 1009 REDACTED DeCant Deposition, 05/24/2016 - Exhibit 258 - 4/6/2004 Memo from Peter Palermo to Doug Uelmen Re. "Remedial Action Plan - BPV Recovery Nitinol Vena Cava Filter", including the Remedial Action Plan SPA 04-03-01 on the Recovery Filter, dated 3/26/2004 1014 REDACTED DeCant Deposition, 05/24/2016 - Exhibit 264 - 6/11/2004 Memo from Pete Palermo to Doug Uelmen Re. "Remedial Action Plan - BPV Recovery Filter - Migration" 1018 REDACTED DeCant Deposition, 05/24/2016 - Exhibit 268 - 9/27/2004 Memo from Pete Palermo to Doug Uelmen Re. "Remedial Action Plan - BPV Recovery Filter - Migration (SPA-04-05-01)" 1022 REDACTED DeCant Deposition, 05/24/2016 - Exhibit 274 - Failure Investigation Report on the Recovery Filter Migration, FIR04-12-01 Rev. 00 1023 1031 1036 DeCant Deposition, 05/24/2016 - Exhibit 275 - Internal Presentation on the G2 Filter System for Permanent Use, detailing the design modifications, features/benefits, and comparison to the Recovery Filter REDACTED Deford Deposition, 06/02/2016 - Exhibit 283 - BPV File on The Recovery Filter Migration, including Minutes from the 2/12/2004 Migration Meeting Deford Deposition, 06/02/2016 - Exhibit 296 - 9/26-9/27/2007 High Importance E-mail exchange b/w Dennis Salzmann, John Van Vleet, and John Reviere of BPV, with others CC’ed, Re. "Comments on Rev H". Discussion about concern for over-reporting of the SIR guidelines re- classification and removal of the retroperitoneal bleed, and replacing consultant John Lehmann 5 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 1053 Edwards Deposition, 01/20/2014 - Exhibit 02 - 3/28/2003 Document RE. "Product Opportunity Appraisal for Recovery Filter", FM070018, Doc No. POA-7081, Version 000 1062 BPV PowerPoint presentation entitled "BPV/AngioMed New Product Development Review Meeting - April 26, 2004" 1130 Ferrara Exh. 3, Email Chain from Regina Busenbark to Robert Ferrara 1-12-2006 1133 Ferrera Deposition, 04/07/2017, Exhibit 11 - Recovery Filter Arm Fracture, Remedial Action Plan September 2, 2004 1140 REDACTED Ferrera Deposition, 04/07/2017, Exhibit 25 - Presentation titled Filter-Fracture Analysis 1149 Fuller Deposition, 01/11/2016 - Exhibit 123 - NMT Report Entitled "Line Extension to the Simon Nitinol Filter®/Straight Line System, To Be Referred As: TRADEMARK Retrievable Filter" 1211 Ganser Deposition, 10/11/2016 - Exhibit 516 - 21 U.S.C.A. § 351, Adultered Drugs and Devices, Effective 7/9/2012 1214 REDACTED 1216 Ganser Deposition, 10/11/2016 - Exhibit 523 - Several memos: (1) 12/8/2004 BPV Memo from John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report - November 2004"; (2) 12/8/2005 BPV Memo from John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report - November 2005; (3) 2/10/2006 BPV Memo from John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report - January 2006; and (4) 2/8/2007 BPV Memo from John McDermott to Tim Ring and John Weiland Re. "Monthly Global PV Report - January 2007 Ganser Deposition, 10/11/2016 - Exhibit 526 - Regulatory Affairs Manual Re. "Product Remedial Actions", RASTD-002 Rev. 08, dated 10/12/2000 1219 REDACTED Ganser Deposition, 10/11/2016 - Exhibit 529 - 6/30/2004 Updated Health Hazard Evaluation from David Ciavarella, M.D. to Doug Uelmen Re. "Migration of Recovery Filter" 1220 REDACTED Ganser Deposition, 10/11/2016 - Exhibit 530 - 8/25/2004 E-mail from Avijit Mukherjee to Robert Carr, Janet Hudnall CC’ed, Re. "Recovery Filter objective statement", proposing one objective statement for the Recovery Filter G1A project, which Hudnall thought sounded "great" 1221 REDACTED Ganser Deposition, 10/11/2016 - Exhibit 533 - 2/15/2006 Health Hazard Evaluation from David Ciavarella to Gin Schulz Re. "G2 Inferior Vena Cava Filter - Migration" 6 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. 1222 Notes REDACTED Description Ganser Deposition, 10/11/2016 - Exhibit 534 - PowerPoint Presentation for a meeting to analyze EVEREST and MAUDE data and provide justifications for proposed changes to G2 filter 1295 Graves Deposition, 02/27/2014 - Exhibit 10 - 3/23/2006 E-mail exchange b/w Mickey Graves and Charlie Simpson, FEA on G2, regarding Historical FEA analysis 1335 Hudnall Deposition, 11/01/2013, Exhibit 21 - Brochure - Recovery Cone Removal System 1336 Hudnall Deposition, 11/01/2013, Exhibit 22 - Recovery G2 Filter System brochure 1337 Hudnall Deposition, 11/01/2013, Exhibit 23 - G2 Brochure (permanent) - Patient Questions & Answers and Bard's website page about G2 Filter System, Indicated for removal, 6/10/2010 1339 REDACTED Hudnall Deposition, 11/01/2013, Exhibit 29 - 7/6/2004 E-mail exchange b/w Hudnall and Bob Cortelezzi Re. "Maude Website Discussion" 1369 Hudson Deposition, 01/17/2014 - Exhibit 16 - 3/24/2004 E-mail from Alex Tessmer to Charlie Benware and Ed Fitzpatrick Re. "Starguide Filter Migration Test Results" 1370 Hudson Deposition, 01/17/2014 - Exhibit 18 - 12/11/2003 E-mail exchange b/w Brian Hudson and Janet Hudnall, others CC’ed, Re. "Special Design Review for Recovery - Meeting Minutes". 1383 Hudson Deposition, 01/17/2014, Exhibit 13 - BPV Engineering Test Report - Characterization of Recovery Filter Migration Resistance in Comparison to Competitive Product - Phase 1, ETR-04-03-02, Rev 0. 1500 Kessler Report - August 7, 2010, John Van Vleet emailed BPV President Jim Beasley, Marketing Director Bill Little, and V.P. of QA Gin Schulz 1517 EVEREST Track wise and MAUDE PowerPoint, BPV-17-01-00188507 1568 Kessler Report - September 30, 2010 memo from Brett Baird to Eclipse DRT, with the subject line “Eclipse PostMarket Design Review/Marketing Summary,” stated: “The objective of the Eclipse Filter project was to enhance the G2 X filter surface finish…" 1578 ETR-06-28-29, revision 0, project #8049, Caudal Migration Test Method Development and G2 Filter Resistance Test Report, 11/27/06, BPVE-01-00789532 7 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 1580 REDACTED Kessler Report -July 12, 2004 email from Bard’s VP of Regulatory Sciences Chris Ganser, to Tim Ring and John Weiland, attached “an executive summary of Recovery Filter adverse events (migration and fracture” 1594 REDACTED Lehmann Deposition, 04/02/2013 - Exhibit 08 - 2/16/2005 E-mail from Charlie Simpson to Hudnall Re. "American Venous Forum - Mary Protocor presented an evaluation of filter related findings from the Maude database" 1612 Lehmann Deposition, 08/07/2014, Exhibit 08 - Updated Health Hazard Evaluation Memo from Ciavarella to Uelmen, re: "Limb Fractures of Recovery Filter", dated 7/9/2004 1613 Lehmann Deposition, 08/07/2014, Exhibit 09 - 6/10/2004 E-mail exchange b/w Ciavarella and Cindi Walcott Re. "Recovery Filter/Detachments" 1616 Little Deposition, 06/27/2016 - Exhibit 2003 - "Patient Questions & Answers" Brochure for the G2 Filter System 1617 Little Deposition, 06/27/2016 - Exhibit 2004 - Chart entitled "EVEREST/Cook Celect Clinical Comparison" 1618 Little Deposition, 06/27/2016 - Exhibit 2005 - 4/27/2010 BPV Memo from Filter Marketing to Bill Little Re. "Filter naming", detailing the name rational for the Eclipse and Denali 1621 Little Deposition, 06/27/2016 - Exhibit 2009 - "Fractures of a Nitinol IVC Filter" presentation by Dr. W. Jay Nicholson on www.CRTonline.org, in which he reviewed a single center experience on fractures with the Bard Recovery and G2 filters 1643 McDermott Deposition, 02/05/2014 - Exhibit 02 - Bard's Product Performance Specification Report on the Recovery Filter and Femoral Delivery System, PPS No. PPS070016 Rev. 0 1680 REDACTED McDonald Deposition, 07/29/2016 - Exhibit 21 - 7/13/2015 Warning Letter from the FDA regarding the 11/25/2014 Inspection of the C.R. Bard facility in NY and the 11/18/2014-1/5/2015 Inspection of the BPV facility in AZ 1740 Modra Deposition, 06/06/2014 - Exhibit 5 - 1/18/2010 E-mail from Bret Baird (Marketing Manager of IVC Filters) to Sales Team list serve (TPE-PV Sales-DG) Re. "Important: Eclipse Vena Cava Filter Launch Details" 1742 Modra Deposition, 06/06/2014 - Exhibit 7 - Product Opportunity Appraisal for the G2 Platinum Concept, POA-8088 Rev. 1.0, Revised on 5/5/2009 1763 Modra, 01/26/2017, Exhibit 771A - Chart entitled "Design Failure Mode and Effects Analysis" on the Simon Nitinol Filter - SNF/SL Filter Sets (DFMEA070042 Rev. 1) 8 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 1787 Orms Deposition, 08/16/2016 - Exhibit 13 - 11/9/2010 E-mail Thread from Chris Smith Re. "Northside(S) Filter Business" 1788 Orms Deposition, 08/16/2016 - Exhibit 14 - 10/2/2010 E-mail Thread from Jeffrey Pellicio Re. "Meridian Commercialization Plan" 1817 Raji-Kubba Deposition, 07/18/2016 - Exhibit 301 - 5/14/2009 E-mail from Bill Edwards to Raji-Kubba and Mike Randall Re. "Tomorrow" 1821 Raji-Kubba Deposition, 07/18/2016 - Exhibit 305 - 11/12/2009 E-mail from Bret Baird to Bill Little, John Van Vleet, and Gin Schulz 1822 Raji-Kubba Deposition, 07/18/2016 - Exhibit 307 - 1/21/2010 Bard Memo from Jeffrey Pellicio to "Reviewers" 1823 Raji-Kubba Deposition, 07/18/2016 - Exhibit 308 - 1/4/2010 E-mail from Gin Schulz to Beasley, Raji-Kubba, Van Vleet, Doherty, and Little Re. "Potential Actions" 1825 Raji-Kubba Deposition, 07/18/2016 - Exhibit 310 - 9/1/2009 E-mail from Mike Randall Re. "0809 Filters Monthly Report.doc" 1861 Only admitted Pgs. 38 & 70 Randall, 01/18/2017, Exhibit 634 - Binder labeled "Meridian Design History File DHF, Vol. II" 1912 Romney Deposition, 09/07/2016 - Exhibit 2039 3/16/2006 E-mail from Jason Greer to Janet Hudnall 1926 Romney, 01/18/2017, Exhibit 2061 - 8/6/2014 E-mail from Schyler Smith, Field Manager for BPV in WashingtonIdaho-Montana, to Kim Romney, Subject redacted, relaying that a redacted doctor had placed a Meridian in the past year and discovered at retrieval that an arm fractured, which imaging confirmed had occurred within 1 week of placement, and was now wondering if he should try to remove the filter or leave it in. Van Vleet forwarded to Treratola in a high importance e-mail on 8/7, requesting that he contact the doctor on Bard's behalf. 1940 REDACTED Schulz Deposition, 01/30/2014 - Exhibit 11 - Chart of Adverse Events and Deaths for all competitors from Prior Evaluation through Q3 2005 and from 1941 REDACTED Schulz Deposition, 01/30/2014 - Exhibit 12 - 11/30/2005 E-mail exchange b/w Gin Schulz and Kellee Jones re Gin, G2 v. Maude and attachments, Spread Sheet - Filter Sales (IMS Q1 '00 to Q4 '04, + Trend Q1 - Q3 '05) 9 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 1944 Schulz Deposition, 01/30/2014 - Exhibit 15 - 5/19/2006 E-mail from Natalie Wong to Gin Schulz and Candi Long, attaching the PowerPoint Presentation on "Recovery (Gen 1) Fracture Slides" (included in exhibit) and RNF Fracture Report (not included), updated to be current as of 5/18/2006 for the Management Review 1945 Schulz Exh. 16, BPVEFILTER-01-00008798 - 851, 10/1/2006 E-mail from Natalie Wong to Several Re. "Fracture Docs" 1946 Schulz Deposition, 01/30/2014 - Exhibit 17 - 2/2/2006 E-mail from Gin Schulz to Several Re. "Minutes" 1947 Schulz Deposition, 01/30/2014 - Exhibit 19 - 5/10/2006 E-mail from Natalie Wong Re. "FDA Proposed Response" 1948 Schulz Deposition, 01/30/2014 - Exhibit 2 - 1/31/2006 E-mail from Gin Schulz to Mickey Graves and Natalie Wong Re. "Caudal" 1949 Schulz Deposition, 01/30/2014 - Exhibit 21 - 6/28/2011 Email Chain from Brian Hudson to Kevin Bovee and Chad Modra Re Talking Points Including attachment 1950 Schulz Deposition, 01/30/2014 - Exhibit 4 - Meeting Summary of the IVC Filter Focus Group meeting held on 6/1/2006 in Chicago, IL at Hilton O'Hare 1951 Schulz Deposition, 01/30/2014 - Exhibit 5 - 1/31/2005 Memo from Peter Palermo to Kerry Chunko Re. "Quality Plan 2005" 2045 Sullivan Deposition, 09/16/2016 - Exhibit 431 - Marketing Brochure - G2 Filter System for Permanent Placement 2048 REDACTED Sullivan Deposition, 09/16/2016 - Exhibit 437 - Document entitled "Failure Investigations/R002 History Review" 2049 Sullivan Deposition, 09/16/2016 - Exhibit 439 - 11/17/2004 Updated Health Hazard Evaluation Memo from David Ciavarella, M.D. to Doug Uelmen, Re: "Limb Fractures of Recovery Filter" 2052 Wong Exh. 546, BPVE-01-01239757 - 775, Draft of PowerPoint Presentation entitled "G2 and G2X Fracture Analysis", dated 11/30/2008 2057 2059 REDACTED Sullivan, 11/03/2016, Exhibit 442 - Recovery Filter Migration Remedial Action Plan SPA-04-12-01 dated 1/4/2005, including the Lehmann Report and Dr. Ciavarella's 12/17/2004 HHE titled "Recovery Filter - Consultant's report" Tessmer Deposition, 06/12/2013 - Exhibit 02 - Project Status Report Form for the Recovery Filter, Project No. 7081, initiated 7/1/2002 with the goal to "Investigate Migration"; FM0700160, Rev. 1 10 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 2061 Tessmer 5, BPVE-01-00000230, 2/4/2004 E-mail from Alex Tessmer to Several Re. "Updated: Filter Migration Flow Loop Test Fixture" 2062 Tessmer Deposition, 06/12/2013 - Exhibit 07 - 1/14/2004 Memo from Rob Carr to File Re. "Design Review Meeting Minutes Response" 2063 Tessmer Deposition, 06/12/2013 - Exhibit 08 - 2/25/2004 E-mail from Alex Tessmer to Robert Carr and Brian Hudson Re. "Filter Migration Test Results 2065 Tessmer Deposition, 06/12/2013 - Exhibit 11 - BPV Engineering Test Report - Characterization of Recovery Filter Migration Resistance When Legs are Crossed or Hooks Removed - Phase 2, ETR-04-03-10, Rev 0 2068 Tessmer Deposition, 06/12/2013 - Exhibit 17 - 6/8/2004 "High" Importance E-mail from Alex Tessmer to Carr, Chanduszko, and Hudson Re. "Filter Improvement DOE" 2069 Tessmer Deposition, 06/12/2013 - Exhibit 19 - 8/26/2004 E-mail from Alex Tessmer to Robert Carr and Avijit Mukherjee Re. "Corporate Presentations" 2090 Tillman, 08/04/2017, Exhibit 1064 - NMT PowerPoint, Cprdos, 06/14/2000 2105 Trerotola, 01/20/2017, Exhibit 692 - 4/30/2015 E-mail from Dr. Trerotola to John Van Vleet, forwarding an article from Forbes Magazine about ALN filters entitled "Effect of a Retrievable IVC Filter Plus Anticoagulation vs. Anticoagulation Alone on Risk of Recurrent PE: A Randomized Clinic Trial". Per Trerotola, "not good for ALN...and maybe not good for the industry". The article was discussed through 5/4, as they were meeting that day to review articles before meeting with JVV. 2149 Vierling Deposition, 05/11/2016 - Exhibit 231 - 12/13/2001 E-mail from Carol Vierling to 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 11 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description of 939 filter complaints from 1/2013 to 1/2015, with a chart detailing whether the MDR classification changed for any complaints 2238 Wilson, 01/31/2017, Exhibit 801 - E-mail string, Subject: Meridian Commercialization Plan 2243 Wong Deposition, 10/18/2016 - Exhibit 537 - 4/23/2004 E-mail from John Lehmann to Carr and Uelmen Re. "Draft data set for statistician" 2244 REDACTED Wong Deposition, 10/18/2016 - Exhibit 538 - 12/17/2004 Health Hazard Evaluation from David Ciavarella to Doug Uelmen Re. "Recovery Filter - Consultant's Report", detailing the 76 reports of the Recovery filter, with 32 serious injury and 10 deaths of the 20,827 units sold during the reporting period 2245 Wong Exh. 540, Recovery Gen 1, Fracture and Migration Complaint Update, 6-20-2006 2245 Wong Deposition, 10/18/2016 - Exhibit 540 - Confidential PowerPoint Presentation entitled "Recovery (Gen 1) Fracture and Migration Complaint Update," dated 6/20/2006 2246 Wong Exh. 541, BPVE-01-01512188, Email from Natalie Wong to Gin Schulz Re RNF Fracture Report 8-1-06, 8-42006 2247 Wong Deposition, 10/18/2016 - Exhibit 542 - 12/2/2009 E-mail exchange b/w Sandy Kerns and Natalie Wong Re. "Filter Fractures" 2248 Wong Deposition, 10/18/2016 - Exhibit 543 - PAT PowerPoint Presentation entitled "G2 Caudal Migration Update," dated 3/2/2006, which Wong circulated via e-mail on 3/2/2006 to several for the presentation that afternoon 2249 Wong Deposition, 10/18/2016 - Exhibit 544 - 5/18/2006 Natalie Wong meeting documents, email re "Caudal Investigation" with attachments of G2 Caudal Report 05.18.06 and Caudal Pre-PAT minutes 2250 Wong Deposition, 10/18/2016 - Exhibit 545 - BPV's Failure Investigation Report on the G2 Filter - Caudal Migration, FIR-06-01-01, unsigned and forwarded by Wong to Gin Schulz for her review, in anticipation of the Friday deadline 2251 Wong Deposition, 10/18/2016 - Exhibit 547 - 4/10/2006 High Importance E-mail from Cindi Walcott to Allen, Schulz, and McDermott Re. "FW: FDA Request for Information" 2252 Wong Deposition, 10/18/2016 - Exhibit 548 - 9/25/2007 E-mail from John Lehmann to John Van Vleet and John Reviere Re. "EVEREST FSR rev H and supporting redlines 12 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 2253 Wong Deposition, 10/18/2016 - Exhibit 549 - 5/27/2004 E-mail from Natalie Wong to Doug Uelmen Re. "Recovery Stats" 2254 Wong Deposition, 10/18/2016 - Exhibit 552 - 2/17/2006 Memo from Mickey Graves and Natalie Wong Re. "Recovery Filter (Generation 1) Product Assessment Team Minutes - Fractures" 3262 REDACTED Complaint File - 03/09/2010, 263280, G2 - RF310F, 2907 Detachment of device or device component 3270 REDACTED Complaint File - 03/30/2010, 266286, G2 - RF310F, 2907 Detachment of device or device component 3304 REDACTED Complaint File - 07/28/2010, 282326, Eclipse - EC500J, 2907 Detachment of device or device component; 2907M Filter Limb(s) 3572 Securities and Exchange Commission Form 10-K for C.R. Bard, Inc. for the fiscal year ended December 31st, 2016 3573 Securities and Exchange Commission Form 10-Q for C.R. Bard, Inc. for the quarterly period ended September 30th, 2017 4327 REDACTED 2/10/06 monthly meeting - redesign due to caudal migration (excludes last 4 pages) 4328 Ganser Exh. 517 Device Labeling Guidance, General Program Memorandum 4330 Asch Deposition, 05/02/2016 - Exhibit 206, July 21, 1999 letter to Dr. Freeland from Dr. Asch 4332 Updated CV of Murray Asch 4392 Truthfulness and Accuracy Statement Vierling Deposition, Exhibit 227 4409 G2 Brochure 2 4412 Email from: Gin Schulz to Kevin Shiffrin regarding Recovery Filter Limb Fractures with attachment of RF Limb detach 4414 Email from Brian Reinkensmeyer to Baird cc Pellicio and Randall re "Filter study Idea" 4415 Email from Mike Randall to Carr and Raji-Kubba re "Misclassified??" 4416 Bill Little email re Eclipse Filter Naming 4420 REDACTED Meridian Vena Cava Filter and Jugular Delivery System Product Performance Specification PPS, Revision 3 13 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 4428 Eclipse Vena Cava Filter Ad 4430 Eclipse Vena Cava Filter Brochure 4433 Eclipse Vena Cava Filter Patient Questions & Answers 4438 G2 Express Vena Cava Filter Brochure 4454 Eclipse Vena Cava Filter Concept POA, Revision 2 4455 Vail Vena Cava Filter DIS 4456 Eclipse Vena Cava Filter Product Performance Specification (PPS) 4457 Vail Filter System DFMEA 4459 Eclipse Vena Cava Filter Jugular Vein Approach IFU 4467 8/12/2011 email from Mike Randall to Joni Creal re Corp approval needed for Cleveland Clinic Studies w/ attached PowerPoint slides re Filter Fixation and Migration: Forces and Design 4468 6/10/2011 email from Mike Randall re Meridian Presentation for SSM 2011 4469 Data Source Evaluation memo from Natalie Wong to Quality Systems Coordinator, October 2010 4486 G2 Express Project Plan FM0700150 Rev 6 1-30-07 4499 Meridian Vena Cava Filter vs. Eclipse Vena Cava Filter 4504 REDACTED Monthly Management Report, dated 4/8/09 4507 REDACTED Monthly Management Report, dated 7/9/09 4509 REDACTED Monthly Management Report, dated 10/8/09 4512 REDACTED Monthly Management Report, dated 1/1/10 4514 REDACTED Monthly Management Report, dated 3/8/10 4515 Only admitted pgs. 12 & 13 Monthly Management Report, dated 4/8/10 14 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 4519 REDACTED Monthly Management Report, dated 8/9/10 4522 REDACTED Monthly Management Report, dated 11/8/10 4528 REDACTED Monthly Management Report, dated 5/9/11 4532 REDACTED Monthly Management Report, dated 9/9/11 4533 REDACTED Monthly Management Report, dated 10/10/11 4534 REDACTED Monthly Management Report, dated 11/8/11 4552 Decant Deposition Exhibit 273, Failure Investigation Report, Recovery Filter Migration FIR-04-12-02, Rev. 00 4554 NMT Medical, BSC Presentation, 5/22/2000 4565 FRE 1006 Chart - Plaintiff's Compilation Complaint Record Detail 4595 Kandarpa Deposition, 07/19/2018 - Exhibit 05 - Medical Monitor Meeting Minutes, August 29, 2005, Beechwood Hotel, Worcester, MA, Version 1.0 (6 pages), signed 12/16/05. *only the last page is bates stamped BBA-00012962 4596 Kandarpa Deposition, 07/19/2018 - Exhibit 06 - Everest Clinical Trial, Medical Monitor Meeting agenda and power point, June 19, 2006, Revision B 4599 Kandarpa Deposition, 07/19/2018 - Exhibit 09 - Summary of Filter Movement, 5mm or greater, Final Clinical Summary Report EVEREST 4600 Kandarpa Deposition, 07/19/2018 - Exhibit 10 - Device Observation Table (as of 10/23/2006) 4601 Kandarpa Deposition, 07/19/2018 - Exhibit 11 - Listing of Device Observations, Final Clinical Summary Report EVEREST 4602 Kandarpa Deposition, 07/19/2018 - Exhibit 12 - Adjudication Manual of Operations, EVEREST (trial exhibit 5983 4603 Kandarpa Deposition, 07/19/2018 - Exhibit 13 - Recovery G2 Filter System - Femoral and Jugular/Subclavian Delivery Kits, Tradition 510(k), October 31, 2007 4604 Kandarpa Deposition, 07/19/2018 - Exhibit 14 - Article entitled "Technical Success and Safety of Retrieval of the G2 Filter in a Prospective, Multicenter Study", Nov. 2009 15 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 4607 Kandarpa Deposition, 07/19/2018 - Exhibit 17 - Memorandum dated June 21, 2006 Subject: G2 Caudal Migration Failure Investigation Team Agenda, From Natalie Wong 4617 VanVleet Deposition, 09/26/2016 - Exhibit 496 - Bard Recovery G2 EVEREST Final Study Report 4785 Fermanich Deposition, 3/17/17 - Exhibit 2: Email, from Tim Hug, 3/19/10, Re: Adversity-How are you going to respond (6 pages) 4786 Fermanich Deposition, 3/17/17 - Exhibit 3: Email, from Tim Hug, 4/27/10, Re: Flair-April Expected Results (3 pages) 4794 Fermanich Deposition, 3/17/17 - Exhibit 11: Email from Tim Hug to Hans Yentz (and others), 2/9/10, Subject: Filter Accounts-Eclipse Transition (2 pages) 4795 Fermanich Deposition, 3/17/17 - Exhibit 12: G2 Filter product brochure (4 pages) 4797 Fermanich Deposition, 3/17/17 - Exhibit 14: Email from Tim Hug to Nine Aghakhan (and others), 3/24/10, Subject: FW: G2 X not available for order (2 pages) 4798 Fermanich Deposition, 3/17/17 - Exhibit 15: Email from Bret Baird to TPW-PV Sales-DG, 4/28/10, Subject: When was the last time… (2 pages) 4800 Fermanich Deposition, 3/17/17 - Exhibit 17: Email from David Ciavarella to Brian Berry (and others), 12/27/05, Subject: FW: G2 Caudal Migrations (2 pages) 4804 Only admitted 1st email, redacted other emails Fermanich Deposition, 3/17/17 - Exhibit 21: Email from Mary Christine Starr to Matt Fermanich, 2/17/11, Subject: RE: Technician Registration (4 pages) 4806 Only admitted pg. 2 Fermanich Deposition, 3/17/17 - Exhibit 23: Email from Cynthia L. Haas to Matt Fermanich, 4/21/11, Subject: RE: Expired product (7 pages) 4809 Fermanich Deposition, 3/17/17 - Exhibit 26: Email from Tim Hug to Matt Fermanich, 12/13/00, Subject: G2 Filter Discontinued (2 pages) 16 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 4812 Fermanich Deposition, 3/17/17 - Exhibit 29: BPV Memo from Filter Marketing to Bill Little, 4/27/10, Subject: Filter naming (2 pages) 4820 Fermanich Deposition, 3/17/17 - Exhibit 37: Health Hazard Evaluation memo from David Ciavarella to Gin Schulz, 2/15/06, Re: G2 Inferior Vena Cava Filter - Migration (3 pages) 4842 Hug Deposition, 8/23/17 - Exhibit 1117: Email to Nine Aghakhan from Tim Hug, 3/8/11, Subject: FW: GW Fem Filter Backorder (2 pages) 4893 GX2 Risk Analysis 4894 Eclipse Risk Analysis 4895 Meridian Risk Analysis 4896 Caudal Migration Testing Meridian and Optease 4897 G2 Express Product Performance Specification, PPS-8058 4938 BPV Consulting Request Form 5001 Dec. 2004 Dear Doctor Letter 5003 Feb. 8, 2005 Conference FDA and BPV re Recovery Retrievable (K031328) 5017 Aug. 5, 1999 R&D Technical Report RNF Migration Study, Design Verification (RD-RPT-100) 5022 RD-LNB-087 Laboratory Notebook 5037 ETR-05-02-02 (Effects of Changes to the Recovery Filter & The Femoral Delivery System on Filter Stresses Based on FEA Analysis) 5126 Guidance for Industry and FDA Reviewers/Staff - Guidance for Cardiovascular Intravascular Filter 510(k) Submissions 5126 Guidance for Industry and FDA Reviewers/Staff - Guidance for Cardiovascular Intravascular Filter 510(k) Submissions 5164 July 8, 2003 Fax IMPRA to FDA re Recovery Retrievable (K031328) 17 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. 5169 Notes REDACTED Description Apr. 25, 2003 Recovery Retrievable Abbreviated 510(k) (K031328) 5177 Nov. 27, 2002 FDA Clearance Letter re Recovery Permanent (K022236) (Substantial Equivalence) 5178 Oct. 25, 2002 Letter IMPRA to FDA re Recovery (K022236) 5179 Oct. 4, 2002 Letter FDA to IMPRA re Recovery (K022236) 5182 Aug. 30, 2002 Letter IMPRA to FDA re Recovery (K022236) 5187 Aug. 5, 2002 Letter FDA to IMPRA re Recovery (K022236) 5189 July 10, 2002 IMPRA Recovery Permanent Special 510(k) (K022236) 5193 Feb. 28, 2005 Letter BPV to FDA re FDA AI re Recovery Retrievable (K031328) 5195 Nov. 30, 2004 Letter FDA to BPV re Recovery IFU and DDL, dear doctor letter 5196 Oct. 5, 2004 Letter BPV to FDA re Recovery IFU and DDL 5197 July 25, 2003 FDA Clearance Letter re Recovery Retrievable (K031328) (Substantial Equivalence) 5232 RD-RPT-116 (RNF Migration Study) (Test report for RD-SOP-035.02) RD-RPT-116 5233 RD-SOP-054.00 (Recovery Filter Endura TEC Fatigue Testing SOP NMT) 5234 RD-RPT-099 (Recovery Filter Endura TEC Fatigue Testing Report NMT) 5238 Slides from Bariatric Surgeons Panel Meeting on Feb. 12, 2005 5239 Jan. 21, 2005 Conference FDA and BPV re DDL and Recovery Retrievable (K031328) 5247 May 11, 2005 BPV began distributing DCL 5252 ETR-04-03-02 (RNF v. Competitive Product -- migration resistance) 5268 NMT's 510(k) (K963016) for modifications to the SNF(submitted by Hogan & Hartson) 5272 Nov. 23, 2009 BPV's Eclipse Filter System Special 510(k) (K093659) 5273 Jan. 14, 2010 FDA Clearance Letter Eclipse Filter (K093659) (Substantial Equivalence) 18 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 5283 G2 IFU (Femoral) PK5250500 Rev. 0 01/08 5290 TD-00456 (EVEREST Study Final Report) 5296 G2 Filter Product Performance Specification, v.2 5301 ETR-05-01-06 Animal Model Evaluation of Recovery Filter G1A Femoral System Report 5302 TPR 05-01-13 G1A Recovery Filter Femoral System Design Verification and Validation Protocol 5303 ETR-05-02-05 (G2® DV&V summary testing) 5304 ETR 05-02-11 G1A Recovery Filter Femoral System Chronic Animal Study Report 5315 Phase 2 Design Review G1A Recovery Filter Femoral Delivery System, BPV-17-01-00121226 -255 5316 Phase 3 Design Review (Design Review 3 & 4) G1A Recovery Filter Femoral Delivery System, BPV-17-0100121256 -286 5322 Nov. 2, 2005 FDA Grants Full Approval of G2 Everest Study (G051304) 5323 Aug. 8, 2005 FDA Grants BPV Conditional Approval for G2 Everest Study (G050134) 5324 July 8, 2005 BPV's original IDE submission re G2 Everest Study (G050134) 5325 REDACTED Oct. 3, 2005 Letter BPV to FDA re G2 Everest Study (G051034) and Conditional Approval 5329 REDACTED June 21, 2006 Letter BPV to FDA re G2 Everest Study (G051304) IDE Supplement 5333 Feb. 2, 2007 Letter BPV to FDA re G2 Everest Study (G051304) Annual Progress Report 5334 Sept. 21, 2007 Letter FDA to BPV Questions re G2 Everest Study (G051304) 5335 Aug. 23, 2007 Letter BPV to FDA re G2 Everest Study (G051304) Annual Progress Report 5336 Oct. 25, 2007 Letter BPV to FDA re Responses to FDA re G2 Everest Study (G051304), BPV-17-01-00123498 -562 5339 Jan. 15, 2008 FDA Clearance Letter G2 Filter Retrievable (K073090) (Substantial Equivalence) 5340 Oct. 31, 2007 BPV's G2 Filter Retrievable Traditional 510(k) (K073090) 5343 Aug. 29, 2005 FDA Clearance Letter re G2 Permanent (K050558) (Substantial Equivalence) 19 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 5344 July 28, 2005 Letter FDA to BPV re AI re Modified Recovery (K050558) 5348 Mar. 30, 2005 Letter FDA to BPV re Modified Recovery (K050558) 5349 Mar. 2, 2005 BPV's Modified Recovery Filter Special 510(k) (K050558) 5350 REDACTED June 3, 2005 Letter BPV to FDA re Modified Recovery conversion Traditional 510(k) (K050558) 5352 Aug. 10, 2005 Letter BPV to FDA Responses to AI re G2 (K050558) 5353 Nov. 25, 2005 FDA Clearance Letter G2 Filter - Jugular (K052578) (Substantial Equivalence) 5354 Sept. 19, 2005 BPV's G2 Filter - Jugular Subclavian Delivery Kit Special 510(k) (K052578) 5361 Sept. 25, 2006 BPV's G2 Filter - Femoral Delivery Kit Special 510(k) (K062887) 5362 Oct. 26, 2006 FDA Clearance Letter G2 Filter - Femoral Delivery Kit (K062887) 5368 July 30, 2008 FDA Clearance Letter G2 Express Filter (K080668) (Substantial Equivalence) 5373 Mar. 7, 2008 BPV's G2 Express Filter Special 510(k) (K080668) 5376 Oct. 31, 2008 FDA Clearance Letter G2X Filter (K082305) Substantial Equivalence 5379 Aug. 12, 2008 BPV's G2X Filter Special 510(k) (K082305) 5384 G2 Express Feasibility Acute Animal Study Report TR-07-05-18 5385 G2 Express Filter Arm Fatigue Comparison TR-07-07-04 5483 sopq1417500 Rev 1 -- Statistical Complaint Trending Procedure PMA Related, BPV-17-01-00144123 - 126 5486 Dec. 17, 2009 Letter from BPV to FDA re Eclipse Filter System Response to FDA Questions (K093659) 5488 June 21, 2010 Letter from BPV to FDA re Eclipse Filter System Response to FDA Questions (K101431) 5523 ETR-04-03-05 (RNF Characterization testing comparing GFO v. NMT manufactured filters) (followed TPR-04-0202) ETR-04-03-05, Rev. 0 (GFO and NMT Manufactured Recovery; Filters Migration Resistance Comparison, Phase 1) 20 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 5526 TPR-04-02-02 (Protocol for RNF Migration Testing v. Competitive) Test Protocol Number TPR-04-02-02 (Rev. 0) -Characterization of the Recovery Filter (RF) - Migration Resistance 5534 Picture of Clot from Feb. 2004 RNF Migration 5536 Meeting Summary from Filter Expert Panel June 1, 2006 5537 June 2006 Expert Panel Meeting Slides 5539 Only admitted pgs. 12 -32 G2 Caudal Migration Failure Investigation Report Aug. 4, 2005 G2 Filter Caudal Migration Failure Investigation Report (FIR-06-01-01) G2 Caudal Migration Failure Investigation Report 5560 Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 Rev 11, BPV-17-01-00166749 776. 5561 Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 Rev 12, BPV-17-01-00166777 806 5563 Standard Operating Procedures / Division Operating Procedures -- CQA-STD-R002 REv 14 5565 Standard Operating Procedures / Division Operating Procedures -- RA-STD-002 Rev 10 5586 May 20, 2010 BPV's Eclipse Filter Special 510(k) (K101431) 5587 June 18, 2010 Letter FDA to BPV re FDA AI Demand re Eclipse (K101431) 5588 Dec. 15, 2009 Letter FDA to BPV re FDA Al Demand re Eclipse (K093659) 5589 June 22, 2010 - FDA Clearance Letter for Eclipse Filter (K101431) (Substantial Equivalence) 5593 Aug. 14, 2009 Conference FDA and BPV re future Eclipse Filter 510(k) 5602 REDACTED FDA CONTACT REPORT January 7 2010 FINAL 5612 REDACTED Nov. 17, 2009 (Filters and future submissions) 5691 Only admitted pgs. 12-32 BPV FDA 483 Update Response March 26, 2015, BPV-17-01-00200156 - 338 21 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. 5706 Notes Only admitted pgs. 48-61 Description September 3 2015 Update Response to Warning Letter issued July 13 2015.pdf 5851 TD-04698 Retrospective IVC Filter Review.pdf 5872 FDA Warning Close Out Letter 5874 Bard filter rate information December 2016 5877 1996 Memo from Veronica Price 5879 April 11, 2006 Letter to FDA re Caudal Migration 5880 March 23, 2006 Letter to FDA re G2 Caudal Migration 5881 May 11, 2006 Letter to FDA re Caudal Migration 5905 Jan. 22, 2005 Email to FDA 5923 REDACTED September 2010 Letter to Clinicians re FDA PHN 5929 TR-07-12-01 (Test Report re G2 Express DV& V Flat Plate Fatigue and Corrosion) 5931 G2X (Jugular) 2009.10 – PK5100070 rev. 5 IFU 5942 January 7, 2010 FDA PowerPoint Presentation 5946 QMBR—July 2006 5949 ETR-06-05-02 (Test report re G2® Clot Trapping Efficiency) 5967 G2 Risk Benefit Analysis (RBA-0003, Rev. 0) 5970 HHE re G2 Caudal Migration February 15, 2006 5991 FM1287100 Rev. 5 (MDR Reportability Guidelines) 5994 TD-04316 Nov. 4, 2015 FDA and Bard Teleconference 5995 TD-04326 Oct. 26, 2015 FDA and Bard Teleconference 6013 Dec. 27, 2010 Letter from BPV to FDA re Meridian 22 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 6046 August 28, 2006 EVEREST Medical Monitor Adjudication Meeting Minutes 6061 Aug. 22, 2005 Internal FDA memo reviewing BPV's Responses to FDA Al re G2 (K050558) 6064 July 26, 2005 Internal FDA memo re BPV Responses to FDA AI re Modified Recovery (K050558) 6075 Nov. 10, 2004 FDA Internal Memo re Dear Doctor Letter 6082 FDA_PRODUCTION_00001288 -- July 2, 2003 Email chain FDA and BPV re Recovery Retrievable (K031328) 6089 Product Development Cycle PPT 6842 ACR-SIR-SPR Practice Parameter for the Performance of Inferior Vena Cava (IVC) Filter Placement for the Prevention of Pulmonary Embolism. Revised 2016. *** Note: “Admitted for the limited purpose to establish knowledge to the medical community, not for the truth of the matter asserted.” 6892 Binkert CA, Drooz AT, Caridi JG, Sands MJ, Bjarnason H, Lynch FC, Rilling WS, Zambuto DA, Stavropoulos SW, Venbrux AC, Kaufman JA. Technical success and safety of retrieval of the G2 filter in a prospective, multicenter study. J Vasc Interv Radiol. 2009 Nov;20(11):1449-53. doi: 10.1016/j.jvir.2009.08.007. 6991 FDA Safety - Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use, 08/09/2010. 6992 FDA Safety Communications, Removing Retrievable Inferior Vena Cava Filters. 05/06/2014. http://wayback.archiveit.org/7993/20170722215731/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm 6993 FDA Safety Communications, Removing Retrievable Inferior Vena Cava Filters: Initial Communication. 08/09/2010. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm 7312 SIR Guidelines for IVC Filters *** Note: “Admitted for the limited purpose to establish knowledge to the medical community, not for the truth of the matter asserted.” 23 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 7411 2008 Surgeon General's Call to Action re PE and DVT 7753 2014 Draft FDA Guidance re Benefit-Risk Factors When Determining Substantial Equivalence in Premarket Notifications 510k with Different Technological Characteristics 7758 2014 FDA Guidance re 510k Evaluating Substantial Equivalence in Premarket Notifications 7771 Braun Vena Tech LP Femoral – October 2010 7787 Cordis Optease Femoral Jugular Antecubital - 2013 7795 Screenshot from FDA, MAUDE - Manufacturer and User Facility Device Experience, available online at https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfmaude/search.cfm 7960 IVC Filters Clinical Overview 7961 Corporate Quality Assurance Manual, Standard for Product Complaint Handling 7962 Corporate Quality Assurance Manual, Standard for Medical Device Reporting 7900 Demonstrative depiction of sales of bard’s retrievable IVC filters 8325 Eclipse IFU 02.2010 PK5100600 Rev. 1 8358 TR-09-10-15 -- Eclipse Flat Plate Fatigue and Corrosion Examination of the Vail (Eclipse) Filter 8359 TR-09-10-16 DV&V Eclipse Filter Arm Fatigue Comparison Study (Project #8113) 8362 Eclipse Filter Patient Questions & Answers 8368 TP-09-10-15 Rev. 0 - Eclipse DV&V Flat Plate Fatigue and Corrosion Test Protocol 8482 Bard IVC Filter G3 Design/Development Timeline 8546 Draft Test Report re Rotary Beam Fatigue of Nitinol Wire 8572 G3 Meeting Minutes Nov 27, 2007 8574 TR 09-10-10, Test Report Cyclic Fatigue Testing of Electropolished Vail Filter Wire 8575 TP 09-10-10, Test Protocol Cyclic Fatigue Testing of Electropolished Vail Filter Wire 24 In re Bard IVC Filters Products Liability Litigation, No. MDL 15-02641-PHX-DGC TRANSFER ORDER (FOURTH) Exhibit 2 – Admitted Exhibit List from Bellwether Trials and Documents No Longer Subject to Protective Order Trial Ex. No. Notes Description 8583 G3 Project Status Report April 19, 2006 8837 Defendants' Exhibit 10 to Joint Report on Determining Filter Type 9080 10/7/07 Email from Dr. Lehman Document deemed no longer subject to the Protective Order Trial Ex. No. 908 Notes Description Ciavarella Deposition, 03/01/2011 - Exhibit 12 - 5/11/2005 "Dear Colleague" letter from BPV re. the Recovery filter system 25

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